Hope you all have a safe and relaxing holiday. 2012 should be an exciting year for Hepatitis C drug development for patients, providers and investors. If any of you have any ideas on how to improve Viral Matters for the new year, please doing hesitate to comment to this thread.
Happy Holidays!
Chris Barnes
Friday, December 23, 2011
Wednesday, December 21, 2011
Clinical Care Options inPractice now offering free online Hepatology textbook...
Clinical Care Options inPractice now offering free online Hepatology textbook....
CCO's inPractice now offering a new Hepatology medical textbook to complement their companion texts in Oncology and HIV. It's free and updated on a regular basis. It's search function allows you to browse for answers at the point of care. It can be found here: http://www.clinicaloptions.com/inPractice.aspx
Some of the texts include:
Virology and Immunology of Hepatitis Viruses
Hepatitis A and E
Hepatitis B Epidemiology, Pathogenesis, Diagnosis, and Natural History
Management of Hepatitis B Infection
Hepatitis B Management in Special Populations
Hepatitis Delta Virus
Hepatitis C Virus Epidemiology, Pathogenesis, Diagnosis, and Natural History
Management of Hepatitis C Infection
Hepatitis C Management in Special Populations
Other Viruses That Affect the Liver
CCO's inPractice now offering a new Hepatology medical textbook to complement their companion texts in Oncology and HIV. It's free and updated on a regular basis. It's search function allows you to browse for answers at the point of care. It can be found here: http://www.clinicaloptions.com/inPractice.aspx
Some of the texts include:
Virology and Immunology of Hepatitis Viruses
Hepatitis A and E
Hepatitis B Epidemiology, Pathogenesis, Diagnosis, and Natural History
Management of Hepatitis B Infection
Hepatitis B Management in Special Populations
Hepatitis Delta Virus
Hepatitis C Virus Epidemiology, Pathogenesis, Diagnosis, and Natural History
Management of Hepatitis C Infection
Hepatitis C Management in Special Populations
Other Viruses That Affect the Liver
FierceBiotech interviews out-going Vertex CEO Matt Emmens and successor Jeffrey Leiden...
An interview with out-going CEO and successor to the throne, Jeffrey Leiden. Emmens appears to be jumping ship at a good time, with a record-breaking 3rd quarter with sales of it's HCV protease inhibitor incivek. Initial 4th quarter sales aren't living up to expectations, however. This may in part be due to the release of promising data hinting at interferon-free treatment for some patients in the next couple of years, reports of higher-than-anticipated anemia, DRESS and Stevens-Johnson syndrome driving providers and patients to use competitor Victrelis or simply taking a chance and waiting for more tolerable therapies. Successor Dr. Leiden faces an uphill battle as Vertex struggles to manage investor, patient and provider expectations as well as the prodigious problem of filling a considerable commercial gap in it's pipeline.
Interview: Vertex CEO concerned about investors' 'hyper-focus' on hep C
December 21, 2011 — 9:37am ET | By Ryan McBride
Matthew Emmens
On the heels of Vertex Pharmaceuticals' ($VRTX) big news last week about changing CEOs next year, FierceBiotech chatted with both current chief executive Matt Emmens (picture, top) and his successor Dr. Jeffrey Leiden. Both Emmens and Leiden are heavyweights in the biopharma industry, with hugely successful drug launches under their belts.
Still, Vertex needs another hit to follow the successful approval and launch of its hepatitis C drug Incivek this year, and it could have one in the experimental cystic fibrosis drug Kalydeco now under FDA review. Much of the company's stock growth of recent years has wilted over the past 6 months on fears that Incivek faces lots of competition in the years ahead from Merck's ($MRK) rival drug and interferon-free treatments against hep C in development, which analysts believe could rapidly eat into Vertex's Incivek business if approved.
Emmens, a 60-year-old biopharma veteran who headed Shire ($SHPGY) prior taking over as CEO of Vertex in 2009, is handing over his chief executive duties to Dr. Leiden on Feb. 1 and will serve as executive chairman until May. Leiden, 56, has served on the board of Vertex since 2009, and he made a name for himself in past leadership roles at Abbott Labs ($ABT), where he oversaw the launch of the blockbuster rheumatoid arthritis drug Humira.
Here's an edited version of FierceBiotech's conversation with Emmens and Leiden on Tuesday:
FierceBiotech: What has been your biggest mistake as CEO of Vertex?
Emmens: You ask tough questions, you know that [laughing]. I don't see any mistakes. I don't know if I'd do anything different. People are going to second-guess a lot of things. But when you look retrospectively at things, without all the information, that's easy to do. When you're there, the decisions that you have to make at the time have quite a different face on them. I don't think I would have done anything differently knowing what I knew then. Knowing what I know now, yeah, in the drug industry I think I would have gone back and bought Genentech when it was three people.
FierceBiotech: What's your biggest concern about Vertex's business heading into 2012?
Emmens: My biggest concern is the way it's perceived by some in the investment community. I think you have a company here that has the best pipeline that I've ever seen in any company in terms of numbers of projects that are successfully proven in man and in a time frame that's not 15 years out. You see, basically, 8 projects here that could all be on the market by [2017], and you see three or four that could be on the market by [2015]. That's very nice, I think. The hyper-focus on hepatitis C has taken people's focus away from that. And I think on top of that, in hepatitis C, we've got a number of projects that could put us in an all-oral regimen in the time frame of [2014]. That's being overlooked.
FierceBiotech: Do you see yourself being a biopharma CEO again after you leave your executive role at Vertex in May?
Emmens: No. I've been working since I was 11 years old. I retired once from Shire, as you probably know. I was on the board here at Vertex and I saw a unique opportunity to use my skill set at a time that the company needed it. I would not be willing to do that for the long term again. I'll be happy to be on boards and advise and help people who are earlier in their career be successful.
FierceBiotech: According to an online poll, lots of people believe that you are the best CEO in biotech this year. Do you agree with them?
Emmens: They were obviously deluded [laughing]. I thank those who voted and it's a nice honor but I have no idea whether I agree with them or not. I did the best I could, and I try to do the best job I can everywhere I've been. And I came here to help the company along into the commercial realm and be successful, and that's happened.
[FierceBiotech's Q&As with Leiden]
FierceBiotech: What's one meaningful change that you plan to bring to Vertex as CEO?
Leiden: I've been very involved in the strategy that Matt and the team have crafted on the management side and the board side. I'm very supportive of that strategy, and I don't anticipate any major changes to it.
FierceBiotech: Did you have any doubts about whether you should take the CEO job?
Leiden: There's no question that Matt is leaving some big shoes to fill, and, frankly, so did Josh Boger. There have been two fantastic CEOs of this company. So that's always a challenge. On the other hand, I see the opportunities at Vertex looking forward are just fantastic. I've had the good fortune to look at a number of biotech and pharma CEO jobs over the last 5 or 6 years, and this was absolutely a unique opportunity because of the pipeline, the team and the proven record of execution here. The job now is to come here and execute over and over, just like they executed on [Incivek and Kalydeco].
FierceBiotech: As a physician and scientist by training, do you see yourself getting more involved in R&D than Matt has been as CEO?
Leiden: I really see my job as integrating the R&D-scientific-medical function with the commercial function. It's what I did at Abbott and I think it made a difference at Abbott. One of the problems that biopharmas have had is a disconnect between the discovery organization, which first makes the molecules, the development organization, which takes it through human trials to approval, and the commercial organization, which obviously brings [a treatment] to patients and the market. The discovery organization makes drugs that are difficult to develop. The development organization develops them in a way that makes it difficult to sell them. So the real key to the success of a modern-day biotech company is a highly integrated organization.
FierceBiotech: Does Vertex spend enough money on R&D, or too little, to keep growing?
Leiden: I've never seen an R&D organization spend as relatively little money and produce so much. The key metric at Vertex is to look at the productivity per dollars spent, and I would hold that up against any company out there--Pfizer, Merck or Genentech. We're spending an 8th to a 10th of what most of the Big Pharmas are spending and producing more.
Read more: Interview: Vertex CEO concerned about investors' 'hyper-focus' on hep C - FierceBiotech http://www.fiercebiotech.com/story/interview-vertex-ceo-concerned-about-investors-hyper-focus-hep-c/2011-12-21#ixzz1hESYZiaF
Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech
Interview: Vertex CEO concerned about investors' 'hyper-focus' on hep C
December 21, 2011 — 9:37am ET | By Ryan McBride
Matthew Emmens
On the heels of Vertex Pharmaceuticals' ($VRTX) big news last week about changing CEOs next year, FierceBiotech chatted with both current chief executive Matt Emmens (picture, top) and his successor Dr. Jeffrey Leiden. Both Emmens and Leiden are heavyweights in the biopharma industry, with hugely successful drug launches under their belts.
Still, Vertex needs another hit to follow the successful approval and launch of its hepatitis C drug Incivek this year, and it could have one in the experimental cystic fibrosis drug Kalydeco now under FDA review. Much of the company's stock growth of recent years has wilted over the past 6 months on fears that Incivek faces lots of competition in the years ahead from Merck's ($MRK) rival drug and interferon-free treatments against hep C in development, which analysts believe could rapidly eat into Vertex's Incivek business if approved.
Emmens, a 60-year-old biopharma veteran who headed Shire ($SHPGY) prior taking over as CEO of Vertex in 2009, is handing over his chief executive duties to Dr. Leiden on Feb. 1 and will serve as executive chairman until May. Leiden, 56, has served on the board of Vertex since 2009, and he made a name for himself in past leadership roles at Abbott Labs ($ABT), where he oversaw the launch of the blockbuster rheumatoid arthritis drug Humira.
Here's an edited version of FierceBiotech's conversation with Emmens and Leiden on Tuesday:
FierceBiotech: What has been your biggest mistake as CEO of Vertex?
Emmens: You ask tough questions, you know that [laughing]. I don't see any mistakes. I don't know if I'd do anything different. People are going to second-guess a lot of things. But when you look retrospectively at things, without all the information, that's easy to do. When you're there, the decisions that you have to make at the time have quite a different face on them. I don't think I would have done anything differently knowing what I knew then. Knowing what I know now, yeah, in the drug industry I think I would have gone back and bought Genentech when it was three people.
FierceBiotech: What's your biggest concern about Vertex's business heading into 2012?
Emmens: My biggest concern is the way it's perceived by some in the investment community. I think you have a company here that has the best pipeline that I've ever seen in any company in terms of numbers of projects that are successfully proven in man and in a time frame that's not 15 years out. You see, basically, 8 projects here that could all be on the market by [2017], and you see three or four that could be on the market by [2015]. That's very nice, I think. The hyper-focus on hepatitis C has taken people's focus away from that. And I think on top of that, in hepatitis C, we've got a number of projects that could put us in an all-oral regimen in the time frame of [2014]. That's being overlooked.
FierceBiotech: Do you see yourself being a biopharma CEO again after you leave your executive role at Vertex in May?
Emmens: No. I've been working since I was 11 years old. I retired once from Shire, as you probably know. I was on the board here at Vertex and I saw a unique opportunity to use my skill set at a time that the company needed it. I would not be willing to do that for the long term again. I'll be happy to be on boards and advise and help people who are earlier in their career be successful.
FierceBiotech: According to an online poll, lots of people believe that you are the best CEO in biotech this year. Do you agree with them?
Emmens: They were obviously deluded [laughing]. I thank those who voted and it's a nice honor but I have no idea whether I agree with them or not. I did the best I could, and I try to do the best job I can everywhere I've been. And I came here to help the company along into the commercial realm and be successful, and that's happened.
[FierceBiotech's Q&As with Leiden]
FierceBiotech: What's one meaningful change that you plan to bring to Vertex as CEO?
Leiden: I've been very involved in the strategy that Matt and the team have crafted on the management side and the board side. I'm very supportive of that strategy, and I don't anticipate any major changes to it.
FierceBiotech: Did you have any doubts about whether you should take the CEO job?
Leiden: There's no question that Matt is leaving some big shoes to fill, and, frankly, so did Josh Boger. There have been two fantastic CEOs of this company. So that's always a challenge. On the other hand, I see the opportunities at Vertex looking forward are just fantastic. I've had the good fortune to look at a number of biotech and pharma CEO jobs over the last 5 or 6 years, and this was absolutely a unique opportunity because of the pipeline, the team and the proven record of execution here. The job now is to come here and execute over and over, just like they executed on [Incivek and Kalydeco].
FierceBiotech: As a physician and scientist by training, do you see yourself getting more involved in R&D than Matt has been as CEO?
Leiden: I really see my job as integrating the R&D-scientific-medical function with the commercial function. It's what I did at Abbott and I think it made a difference at Abbott. One of the problems that biopharmas have had is a disconnect between the discovery organization, which first makes the molecules, the development organization, which takes it through human trials to approval, and the commercial organization, which obviously brings [a treatment] to patients and the market. The discovery organization makes drugs that are difficult to develop. The development organization develops them in a way that makes it difficult to sell them. So the real key to the success of a modern-day biotech company is a highly integrated organization.
FierceBiotech: Does Vertex spend enough money on R&D, or too little, to keep growing?
Leiden: I've never seen an R&D organization spend as relatively little money and produce so much. The key metric at Vertex is to look at the productivity per dollars spent, and I would hold that up against any company out there--Pfizer, Merck or Genentech. We're spending an 8th to a 10th of what most of the Big Pharmas are spending and producing more.
Read more: Interview: Vertex CEO concerned about investors' 'hyper-focus' on hep C - FierceBiotech http://www.fiercebiotech.com/story/interview-vertex-ceo-concerned-about-investors-hyper-focus-hep-c/2011-12-21#ixzz1hESYZiaF
Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech
Scynexis aims to raise $15M to support phase 2 development of cycophilin inhibitor SCY-635...
(Scynexis aims to raise $15 M to support phase 2 trials for it's lead candidate, cycophilin inhibitor SCY-635 which they hope to eventually replace recombinant interferon)
Scynexis aims to raise $15M; hepatitis C drug candidate in phase 2 trials
Posted By Frank Vinluan On December 19, 2011 @ 11:09 am In MedCity News
Drug discovery and development firm Scynexis which is moving forward on a new hepatitis C treatment, has raised $5 million in a fundraising effort targeted to reach up to $15 million.
A total of nine investors have invested in the round that is a combination of equity, debt, warrants and options, according to securities filings. Durham, North Carolina-based Scynexis’ investors include Alta Partners, Burrill & Company, KBL Healthcare Ventures, Societe Generale, Ventech, CDC Innovation and SR One, the venture capital arm of GlaxoSmithKline. Scynexis’ last fundraiser was in 2008 when the company hauled in $13.5 million in equity financing.
Scynexis collaborates with pharmaceutical companies on their drug discovery and development efforts and it already has a long list of drug partners that include Merck, Sanofi and Roche. In the last five years, Scynexis has helped its partners advance 11 preclinical and clinical drug candidates.
The company also has drug candidates of its own. Scynexis’ proprietary internal pipeline is based on cyclophilin inhibitors, a class of drugs that Scynexis believes hold potential to treatment of a broad range of diseases. Hepatitis C is Scynexis’ first target. SCY-635, the first drug candidate to emerge from the drug pipeline, is being studied as a treatment for hepatitis C virus infection. The compound, currently in phase 2 clinical trials, works by reactivating the body’s natural defense mechanism that makes it capable of inhibiting replication of the virus.
According to the World Health Organization, an estimated 3 percent of the world’s population is infected with hepatitis C and there are more than 170 million carriers at risk of developing liver cirrhosis or liver cancer. Scynexis sees SCY-635 as meeting an unmet medical need by serving as a potential replacement for recombinant interferon, the current standard hepatitis C treatment that has several serious side effects.
Scynexis aims to raise $15M; hepatitis C drug candidate in phase 2 trials
Posted By Frank Vinluan On December 19, 2011 @ 11:09 am In MedCity News
Drug discovery and development firm Scynexis which is moving forward on a new hepatitis C treatment, has raised $5 million in a fundraising effort targeted to reach up to $15 million.
A total of nine investors have invested in the round that is a combination of equity, debt, warrants and options, according to securities filings. Durham, North Carolina-based Scynexis’ investors include Alta Partners, Burrill & Company, KBL Healthcare Ventures, Societe Generale, Ventech, CDC Innovation and SR One, the venture capital arm of GlaxoSmithKline. Scynexis’ last fundraiser was in 2008 when the company hauled in $13.5 million in equity financing.
Scynexis collaborates with pharmaceutical companies on their drug discovery and development efforts and it already has a long list of drug partners that include Merck, Sanofi and Roche. In the last five years, Scynexis has helped its partners advance 11 preclinical and clinical drug candidates.
The company also has drug candidates of its own. Scynexis’ proprietary internal pipeline is based on cyclophilin inhibitors, a class of drugs that Scynexis believes hold potential to treatment of a broad range of diseases. Hepatitis C is Scynexis’ first target. SCY-635, the first drug candidate to emerge from the drug pipeline, is being studied as a treatment for hepatitis C virus infection. The compound, currently in phase 2 clinical trials, works by reactivating the body’s natural defense mechanism that makes it capable of inhibiting replication of the virus.
According to the World Health Organization, an estimated 3 percent of the world’s population is infected with hepatitis C and there are more than 170 million carriers at risk of developing liver cirrhosis or liver cancer. Scynexis sees SCY-635 as meeting an unmet medical need by serving as a potential replacement for recombinant interferon, the current standard hepatitis C treatment that has several serious side effects.
Monday, December 19, 2011
Committee is split on whether or not to use chimpanzees in US viral drug research...
Acording to an article posted on the Fox News website,guidelines for chimpanzee use in U.S. research are being crafted by committee, however "The committee's 10 members were also split on whether a vaccine intended to prevent or minimize hepatitis C infection would require safety testing on chimpanzees."
First Guidelines for Lab Chimps Drawn Up
By Wynne Parry
For the first time, criteria have been issued on research using our closest relatives in the animal kingdom, chimpanzees.
Guidelines now govern the use of our closest living relatives, chimpanzees, in federally funded U.S. research, and because of them, some biomedical studies are likely to come to an end.
In fact, nearly all research using chimpanzees to develop drugs or answer other questions with medical applications for humans should end, according to a committee charged with establishing the first set of criteria for research on chimpanzees. The committee released its report Thursday (Dec. 15).
Research into genetic or behavioral questions — such as looking for insight into human behavior by studying how chimpanzees help one another out, or searching for the genetic underpinnings of language — are acceptable, or could become so with only minor modifications, according the committee convened by the National Academy of Sciences.
These types of projects are typically less invasive than biomedical research, which could involve, for instance, infecting chimpanzees with a virus.
For example, in behavioral research, chimpanzees — which, like humans, are social — must live with others, and may not be anesthetized by being shot with a dart. However, chimpanzees can be trained to offer their arms to have blood drawn or accept anesthesia so they can be examined, according to the committee.
New principles
The criteria for both types of research are based upon three general guidelines: The knowledge gained by the research must be necessary to advance public health; the research cannot ethically be done on a human being, or is not possible on another animal or in something that is not a living organism; and the chimpanzees used in the research must be given appropriate places to live.
In practice, this means the National Institutes of Health (NIH) will not award any new grants for research until an assessment process is in place, and a project-by-project review will be conducted to determine if ongoing research fits the criteria, said NIH Director Francis Collins, who accepted the committee's recommendations.
"Chimpanzees are our closest relatives in the animal kingdom, providing exceptional insights into human biology, and the need for special consideration and respect," Collins said in a statement on Thursday.
He estimated that about 37 research projects might be affected, and that, of these, about half may not be continued.
These criteria will only apply to research projects that receive some kind of NIH support, including animals used by private groups but housed using federal money, according to committee member Warner Greene, a virologist at the University of California, San Francisco.
The exceptions
Although the committee did not review projects, it did provide two examples of biomedical research that met its criteria to continue, at least temporarily.
Research using chimps to study monoclonal antibodies was given a temporary reprieve to avoid substantially slowing research. Monoclonal antibodies are similar to the regular antibodies your immune system produces, but they are designed to target specific molecules. They are used to treat a variety of conditions, including cancer and autoimmune disorders.
The committee's 10 members were also split on whether a vaccine intended to prevent or minimize hepatitis C infection would require safety testing on chimpanzees.
"I think the committee accurately identified the few biomedical topics for which continuing involvement of chimpanzees is essential," said Joseph Erwin, a primatologist who specializes in the care of captive primates and the neurobiology of aging.
Erwin, along with many others, presented his views to the committee during its deliberations.
"If research is done in humane ways under good conditions with consideration for the animals, I don't see why anyone should be against it," Erwin said. "People who oppose all animal research seem not to be aware that scientific research can be done without harming or hurting animals. In fact, that is the only kind of study I find acceptable."
A future of chimpanzee research?
But Theodora Capaldo, president of the New England Anti-Vivisection Society/Release & Restitution for Chimpanzees, said she believes the new guidelines mean an end to all work with chimpanzees, including those typically considered less invasive, such as for instance, a behavioral study involving an MRI scan.
"If that criteria is scrupulously applied, it is an end to chimpanzee research. We do not believe there are any projects out there that can meet that criteria," Capaldo said.
Even though the committee did leave the door open to future testing on chimpanzees, biomedical research on chimpanzees is on its way out, said Andrew Rowan, chief scientific officer of the Humane Society of the United States.
"Biomedical and research technology has changed dramatically in the last 25 years. What was necessary in 1980 is no longer necessary today, and what is necessary today will no longer be necessary in 2020," Rowan said.
The use of cell cultures — when cells are grown without an organism — allows researchers to generate higher volumes of data under more easily controlled conditions and have replaced animals, including chimpanzees, in labs, Rowan said.
"Chimpanzees deserve greater moral consideration than we are currently giving them. It is going to come to an end, the question now is when," Rowan said.
First Guidelines for Lab Chimps Drawn Up
By Wynne Parry
For the first time, criteria have been issued on research using our closest relatives in the animal kingdom, chimpanzees.
Guidelines now govern the use of our closest living relatives, chimpanzees, in federally funded U.S. research, and because of them, some biomedical studies are likely to come to an end.
In fact, nearly all research using chimpanzees to develop drugs or answer other questions with medical applications for humans should end, according to a committee charged with establishing the first set of criteria for research on chimpanzees. The committee released its report Thursday (Dec. 15).
Research into genetic or behavioral questions — such as looking for insight into human behavior by studying how chimpanzees help one another out, or searching for the genetic underpinnings of language — are acceptable, or could become so with only minor modifications, according the committee convened by the National Academy of Sciences.
These types of projects are typically less invasive than biomedical research, which could involve, for instance, infecting chimpanzees with a virus.
For example, in behavioral research, chimpanzees — which, like humans, are social — must live with others, and may not be anesthetized by being shot with a dart. However, chimpanzees can be trained to offer their arms to have blood drawn or accept anesthesia so they can be examined, according to the committee.
New principles
The criteria for both types of research are based upon three general guidelines: The knowledge gained by the research must be necessary to advance public health; the research cannot ethically be done on a human being, or is not possible on another animal or in something that is not a living organism; and the chimpanzees used in the research must be given appropriate places to live.
In practice, this means the National Institutes of Health (NIH) will not award any new grants for research until an assessment process is in place, and a project-by-project review will be conducted to determine if ongoing research fits the criteria, said NIH Director Francis Collins, who accepted the committee's recommendations.
"Chimpanzees are our closest relatives in the animal kingdom, providing exceptional insights into human biology, and the need for special consideration and respect," Collins said in a statement on Thursday.
He estimated that about 37 research projects might be affected, and that, of these, about half may not be continued.
These criteria will only apply to research projects that receive some kind of NIH support, including animals used by private groups but housed using federal money, according to committee member Warner Greene, a virologist at the University of California, San Francisco.
The exceptions
Although the committee did not review projects, it did provide two examples of biomedical research that met its criteria to continue, at least temporarily.
Research using chimps to study monoclonal antibodies was given a temporary reprieve to avoid substantially slowing research. Monoclonal antibodies are similar to the regular antibodies your immune system produces, but they are designed to target specific molecules. They are used to treat a variety of conditions, including cancer and autoimmune disorders.
The committee's 10 members were also split on whether a vaccine intended to prevent or minimize hepatitis C infection would require safety testing on chimpanzees.
"I think the committee accurately identified the few biomedical topics for which continuing involvement of chimpanzees is essential," said Joseph Erwin, a primatologist who specializes in the care of captive primates and the neurobiology of aging.
Erwin, along with many others, presented his views to the committee during its deliberations.
"If research is done in humane ways under good conditions with consideration for the animals, I don't see why anyone should be against it," Erwin said. "People who oppose all animal research seem not to be aware that scientific research can be done without harming or hurting animals. In fact, that is the only kind of study I find acceptable."
A future of chimpanzee research?
But Theodora Capaldo, president of the New England Anti-Vivisection Society/Release & Restitution for Chimpanzees, said she believes the new guidelines mean an end to all work with chimpanzees, including those typically considered less invasive, such as for instance, a behavioral study involving an MRI scan.
"If that criteria is scrupulously applied, it is an end to chimpanzee research. We do not believe there are any projects out there that can meet that criteria," Capaldo said.
Even though the committee did leave the door open to future testing on chimpanzees, biomedical research on chimpanzees is on its way out, said Andrew Rowan, chief scientific officer of the Humane Society of the United States.
"Biomedical and research technology has changed dramatically in the last 25 years. What was necessary in 1980 is no longer necessary today, and what is necessary today will no longer be necessary in 2020," Rowan said.
The use of cell cultures — when cells are grown without an organism — allows researchers to generate higher volumes of data under more easily controlled conditions and have replaced animals, including chimpanzees, in labs, Rowan said.
"Chimpanzees deserve greater moral consideration than we are currently giving them. It is going to come to an end, the question now is when," Rowan said.
Friday, December 16, 2011
Merck & Roche team up for HCV product trials..
The unlikely pairing of these former arch-enemies and Hepatitis C juggernauts Merck and Roche continue to raise eyebrows. This time, the duo had agreed to a series of planned clinical trials to investigate combinations of currently marketed and investigational compounds to treat HCV, with a focus on the genotype 1 population. The first appears to be a phase II study called DYNAMO 1, which will look at Boceprevir in combination with with Roche's mericitabine (RO5024048), their oral HCV NS5B nucleoside polymerase inhibitor in combination with pegylated interferon (Pegasys, for those keeping a scorecard) and ribavirin in genotype 1 patients with a prior null response to P/R. The fact that there doesn't appear to be an interferon-free arm leads me to believe that these two interferon giants do not believe that prior null responders can be cured without interferon, which, to their credit, may indeed be the case.
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
New Clinical Trial Will Evaluate an Investigational Therapeutic Regimen with VICTRELIS™ (boceprevir)
WHITEHOUSE STATION, N.J., Dec. 15, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck, in collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY), has initiated the first of a series of planned clinical trials to examine novel combinations of marketed and investigational medicines to expedite the availability of potential new treatment regimens for patients with chronic hepatitis C virus (HCV) genotype 1 infection. Clinical development collaboration is part of the overarching strategic agreement between Merck and Roche to improve treatment, diagnosis and awareness of chronic HCV in developed and emerging markets.
"VICTRELIS is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus," said Eliav Barr, M.D., vice president, Infectious Diseases Project Leadership and Management, Merck Research Laboratories. "The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform VICTRELIS provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasizes our ongoing commitment to seeking novel treatment options for patients with chronic HCV."
The first trial is designed to provide clinical data on the use of VICTRELIS™ (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally. For further details of the clinical trial please visit www.clinicaltrials.gov, or contact (888) 662-6728 (U.S. only) or Genentechclinicaltrials@drug info.com.
Indications and usage for VICTRELIS
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011 for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
•VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
•VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
•VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
•Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and neutropenia have been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
New Clinical Trial Will Evaluate an Investigational Therapeutic Regimen with VICTRELIS™ (boceprevir)
WHITEHOUSE STATION, N.J., Dec. 15, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck, in collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY), has initiated the first of a series of planned clinical trials to examine novel combinations of marketed and investigational medicines to expedite the availability of potential new treatment regimens for patients with chronic hepatitis C virus (HCV) genotype 1 infection. Clinical development collaboration is part of the overarching strategic agreement between Merck and Roche to improve treatment, diagnosis and awareness of chronic HCV in developed and emerging markets.
"VICTRELIS is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus," said Eliav Barr, M.D., vice president, Infectious Diseases Project Leadership and Management, Merck Research Laboratories. "The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform VICTRELIS provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasizes our ongoing commitment to seeking novel treatment options for patients with chronic HCV."
The first trial is designed to provide clinical data on the use of VICTRELIS™ (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally. For further details of the clinical trial please visit www.clinicaltrials.gov, or contact (888) 662-6728 (U.S. only) or Genentechclinicaltrials@drug info.com.
Indications and usage for VICTRELIS
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011 for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
•VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
•VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
•VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
•Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and neutropenia have been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
The Motley Fool - Investors flee Inhibitex and Idenix stock on Pharmasset PSI-938 news...
Idenix Shares Plunged: What You Need to Know
By Evan Niu, The Motley Fool
Posted 3:59PM 12/16/11 Investing
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Idenix (NAS: IDIX) are plunging today, down by 16% at the low, after competitor Pharmasset (NAS: VRUS) discontinued use of one of its experimental drugs due to safety concerns.
So what: Pharmasset's experimental hepatitis C drug PSI-938 reported complications with liver function, although the developments aren't expected to interfere with Gilead Sciences' (NAS: GILD) planned acquisition of the company. Idenix also has a hepatitis C drug in its pipeline, which is the company's current focus.
Now what: The news is causing concern among some hepatitis C drugmakers, including Inhibitex (NAS: INHX) , which is also seeing downside today. Interestingly, rival Vertex Pharmaceuticals (NAS: VRTX) is seeing healthy gains, with setbacks for PSI-938 considered positive for Vertex. Idenix's and Inhibitex's hepatitis C drugs are more similar to Pharmassets, which is causing investors to flee for cover.
By Evan Niu, The Motley Fool
Posted 3:59PM 12/16/11 Investing
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Idenix (NAS: IDIX) are plunging today, down by 16% at the low, after competitor Pharmasset (NAS: VRUS) discontinued use of one of its experimental drugs due to safety concerns.
So what: Pharmasset's experimental hepatitis C drug PSI-938 reported complications with liver function, although the developments aren't expected to interfere with Gilead Sciences' (NAS: GILD) planned acquisition of the company. Idenix also has a hepatitis C drug in its pipeline, which is the company's current focus.
Now what: The news is causing concern among some hepatitis C drugmakers, including Inhibitex (NAS: INHX) , which is also seeing downside today. Interestingly, rival Vertex Pharmaceuticals (NAS: VRTX) is seeing healthy gains, with setbacks for PSI-938 considered positive for Vertex. Idenix's and Inhibitex's hepatitis C drugs are more similar to Pharmassets, which is causing investors to flee for cover.
Wednesday, December 14, 2011
Boehringer Ingelheim enrolls final patient in BI 210335 HCV protease inhibitor phase III trial....
The race for the 2nd generation of HCV Direct Acting Antivirals continues to be too close to call, with BI's BI 210335 HCV protease inhibitor finalizing it's last patient for it's phase III trial. The asute observer of the HCV marketplace will recall the interim results of BI's SOUND-C2 trial looking at the interferon-free combo of BI 201335 and BI's BI 207127 polymerase inhibitor in genotype 1 tx-naive patients. At week 12, 76% of patients had VR with a respectable 63% of patients achieved SVR12.
From Medical News Today
Boehringer Ingelheim Completes Patient Entry For Phase III Trial Program In Hepatitis C
12 Dec 2011
According to Boehringer Ingelheim's announcement, the company's large-scale Phase III clinical trial program for BI210335, an investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV) has randomized the final patient for treatment.
Their current extensive trial program is conducted in 15 countries, with key regions in the E.U., Japan, the U.S., Canada, Korea, Taiwan and Russia at over 350 sites and involves almost 2,000 treatment-experienced and treatment-naïve patients overall.
The program's three Phase III trials will be carried out to assess BI 201335 combined with the golden standard treatment of pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. The majority of HCV patients infected with the genotype 1 virus are amongst the most difficult patient groups to treat. The study program's primary clinical endpoint is the assessment of "sustained viral response" (SVR), considered to be a viral cure, with results from the Phase III trials expected in the first half of 2013.
The complete BI 201335 program was awarded a Fast Track designation by the FDA. The U.S. Food and Drug Administration has designed the Fast Track process to enable the development and review process of important new drugs to treat serious diseases more rapidly than usual to fill an unmet medical need.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim said: "We are progressing our BI 201335 program with a high priority to leverage its potential to improve cure rates in HCV treatment. We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide."
Last month at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, Boehringer Ingelheim presented findings of their Phase IIb trial, which demonstrated that the interferon-free combination of BI 201335, with their polymerase inhibitor BI 207127 (SOUND-C2) resulting in 76% of patients achieving a virological response at week 12 and 63% of patients achieved SVR12, an undetectable virus 12 weeks after treatment, at week 16.
In addition to their BI 201335 results, the company also presented their SILEN-C1 and SILEN-C3 study results at the AASLD, demonstrating that BI 201335/ PegIFN/RBV's potentially shortens the time of treatment and improves the likelihood of viral cure (SVR). These Phase IIb results provide a strong case for further development, whilst BI 201335 continues its progress through Phase III.
Written by: Grace Rattue
From Medical News Today
Boehringer Ingelheim Completes Patient Entry For Phase III Trial Program In Hepatitis C
12 Dec 2011
According to Boehringer Ingelheim's announcement, the company's large-scale Phase III clinical trial program for BI210335, an investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV) has randomized the final patient for treatment.
Their current extensive trial program is conducted in 15 countries, with key regions in the E.U., Japan, the U.S., Canada, Korea, Taiwan and Russia at over 350 sites and involves almost 2,000 treatment-experienced and treatment-naïve patients overall.
The program's three Phase III trials will be carried out to assess BI 201335 combined with the golden standard treatment of pegylated interferon (pegIFN) and ribavirin (RBV) in patients with chronic genotype-1 HCV. The majority of HCV patients infected with the genotype 1 virus are amongst the most difficult patient groups to treat. The study program's primary clinical endpoint is the assessment of "sustained viral response" (SVR), considered to be a viral cure, with results from the Phase III trials expected in the first half of 2013.
The complete BI 201335 program was awarded a Fast Track designation by the FDA. The U.S. Food and Drug Administration has designed the Fast Track process to enable the development and review process of important new drugs to treat serious diseases more rapidly than usual to fill an unmet medical need.
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim said: "We are progressing our BI 201335 program with a high priority to leverage its potential to improve cure rates in HCV treatment. We believe our HCV-pipeline may become an important tool to fight a chronic disease that affects over 170 million people worldwide."
Last month at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA, Boehringer Ingelheim presented findings of their Phase IIb trial, which demonstrated that the interferon-free combination of BI 201335, with their polymerase inhibitor BI 207127 (SOUND-C2) resulting in 76% of patients achieving a virological response at week 12 and 63% of patients achieved SVR12, an undetectable virus 12 weeks after treatment, at week 16.
In addition to their BI 201335 results, the company also presented their SILEN-C1 and SILEN-C3 study results at the AASLD, demonstrating that BI 201335/ PegIFN/RBV's potentially shortens the time of treatment and improves the likelihood of viral cure (SVR). These Phase IIb results provide a strong case for further development, whilst BI 201335 continues its progress through Phase III.
Written by: Grace Rattue
Tuesday, December 13, 2011
Xconomy.com: The Hepatitis C Market: Biotech’s Version of the Daytona 500
National Biotech Editor of Xconomy, Luke Timmerman likens the current HCV market to Daytona 500 vs a toe-to-toe slug fest between two competitors. Surprises lurk at every turn as a wide array of competitors, from Big Pharma to little Biotech upstarts vie to out-maneuver each other for the championship. This makes for trecherous ground for investors, as we know anything can happen and usually does in drug development. But for the patient suffering from HCV, all this is good news. Intense competition usually sparks innovation - we've already seen from the recent AASLD meeting that a possible all-oral regimen for HCV without the need for interferon may be a distinct possibility for some patients. possibly within 5 years. A good read whether you're an investor, treater or a patient.
Biotech rivalries are sometimes a bit like boxing matches, where you have two lone fighters vying for the prize. But the hepatitis C market is turning into a battle royal that’s more wide open and unpredictable, with all the competitive maneuvering, surprise crashes, and comebacks you might expect from the Daytona 500.
The medical advances in hepatitis C have been dizzying this year, especially in what it means in terms of multi-billion dollar business implications. The safest thing to say is that there’s plenty of good news for patients this year, but that shareholders in the major hepatitis C drug developers had better hold on tight as a new standard of care gets established.
Some commentators figured that Gilead Sciences (NASDAQ: GILD), the world’s biggest maker of HIV drugs, had essentially locked up the dominant position in this new drug class through its $11 billion acquisition last month of Princeton, NJ-based Pharmasset (NASDAQ: VRUS). But it’s still too soon for anyone to declare victory over the wily and fast-mutating virus that causes hepatitis C. Given the way drug development is going now, it’s possible we could have dueling antiviral drug cocktails that cure almost 100 percent of patients within five years. And before we get there, we’re going to see some fascinating chess moves—and probably a few surprising collaborations—from companies like Vertex Pharmaceuticals, Merck, Roche, Johnson & Johnson, Bristol-Myers Squibb, and Abbott Laboratories, as well as several smaller biotech startups like Alpharetta, GA-based Inhibitex (NASDAQ: INHX).
The Pharmasset compound that prompted Gilead to write such a big check, PSI-7977, is “certainly not a panacea, not the lone answer,” says Kleanthis Xanthopoulos, the CEO of San Diego-based Regulus Therapeutics, and the co-founder of another hepatitis C drug developer, Anadys Pharmaceuticals.
Regulus Therapeutics CEO Kleanthis Xanthopoulos
Xanthopoulos says Gilead was “taken to the cleaners,” and that the hepatitis C market is still up for grabs. “It’s going to take some time before people figure out how it plays out,” he says. The Pharmasset drug “is a powerful player, but you will need other direct-acting antivirals. You want to go to a 100 percent cure rate. I can guarantee the Pharmasset compound isn’t going to do it alone.”
Hepatitis C has never really captured big headlines in the U.S., as it has never benefitted from massive awareness boosting campaigns that have supported research for, say, HIV, or breast cancer. But hepatitis C has clearly emerged as one of the biggest opportunities in pharmaceuticals over the past few years. There are more than 3 million people in the U.S., and an estimated 170 million worldwide, with this liver infection that can lead to cirrhosis and liver cancer. Most people have never bothered to get treated, partly because the infection takes years to fully wreak havoc. The other reason is the standard of care with a combination of drugs—pegylated interferon alpha and ribavirin—causes flu-like symptoms that last for almost a year, and usually cures only 30-40 percent of patients. Essentially, most people figure the treatment is worse than the disease.
Vertex Pharmaceuticals changed the equation back in May. The company won FDA approval for a direct antiviral drug, a protease inhibitor called telaprevir (Incivek), that is added to the usual two-drug combo regimen. By adding the Vertex drug, researchers saw the cure rate boom to almost 80 percent of patients, while cutting the treatment time with the other drugs in half. The Vertex drug also significantly raised the cure rate for patients who failed to respond to prior rounds of therapy.
Vertex looked golden for a while, as its stock soared above $55 a share, sending its market value above $10 billion. Analysts were raving about how Vertex smashed sales expectations in its first few months on the market, and started turning profitable in just its second quarter of selling the drug. Waves of patients were suddenly showing up at doctors’ offices to get treatment for hepatitis C, now that the odds of a cure were so much higher.
But important as the Vertex advance has been, researchers have made it clear that this story isn’t over. The ultimate goal is to get rid of interferon, and its side effects, so that physicians can count on some combination of direct antivirals that can be taken as oral pills. That might include Vertex’s drug in combination with others, or might not.
So that’s why Vertex, and other companies, have feverishly been looking to mix and match various hepatitis C drugs. It’s all part of a quest to come up with the ideal combo that can raise the bar on cure rates, minimize side effects, and maximize convenience.
While people on Wall Street like to embrace a simple storyline with clear winners and losers, the hepatitis C virus is one tricky adversary. Like HIV, it has a tendency to mutate and develop resistance capabilities, whenever scientists throw a new antiviral drug against it. So there isn’t likely to be a single magic bullet. The most likely route to success is with a combination of two, three, or maybe four antiviral drugs that attack the virus from different angles, making it much harder for the bug to mutate and escape one drug.
As Steve Worland, the CEO of San Diego-based Anadys Pharmaceuticals, put it in a guest editorial for Xconomy in September, there are at least four important categories of hepatitis C antivirals. There are protease inhibitors on the market like Vertex’s drug and Merck’s boceprevir (Victrelis). There are nucleotide polymerase inhibitors like Pharmasset’s PSI-7977 and a rival drug called mericitabine from Roche. There are non-nucleotide polymerase inhibitors in the works from Abbott Laboratories, Vertex, and Anadys (which Roche acquired this fall for $230 million.) And Bristol-Myers Squibb is betting on another kind of compound, an NS5A inhibitor. (You could also count microRNA therapies, which Santaris Pharma and Regulus are working on at earlier stages of development.)
Just this year, we’ve seen some fascinating jockeying for position. Drug companies often don’t like to test combinations of experimental drugs together in clinical trials, because when side effects emerge, people often like to point the finger at the other guy’s drug. And who wants to divvy up the profits with some other pharma giant when you have the whole thing yourself?
But with hepatitis C, the market opportunity is so big, and the variety of drugs to attack it is so broad, that pharma companies have set aside those concerns just to get a piece of the action. We’ve already seen Merck and Roche form a partnership to co-market Victrelis against the leading drug on the market from Vertex. Gilead just shelled out the breathtaking sum of $11 billion for Pharmasset, even though the smaller company’s lead compound still has to navigate the third and final phase of clinical trials required for FDA approval. Bristol-Myers Squibb and Johnson & Johnson have teamed up in an interesting new collaboration. Roche, through internal efforts and acquisitions, has sought to put all the pieces of the puzzle together under one roof—a protease inhibitor, a nucleotide polymerase inhibitor, a non-nucleotide polymerase inhibitor.
Nobody knows which compounds will match up best together, which ones will be too toxic in combination, or even how many antivirals will be needed to raise the cure rate. But it’s worth noting that Vertex raised the bar very high, by getting cure rates up to around 80 percent. Doctors are certainly eager to get rid of the nasty interferon part of the regimen, but they will only do that when a new regimen can do at least as well on cure rates. And any of these drugs can be derailed by somewhat mild side effects, since the bar on safety is set quite high already.
It might be relatively safe and simple to declare Gilead/Pharmasset the winners in this market, but this race isn’t even close to over. There are 200 laps in the Daytona 500, and in the hepatitis C race, I’d say we’re at about lap 50. There are going to be some fascinating strategic maneuvers, and maybe even a spectacular crash or two, before somebody zooms in under the checkered flag.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com/ldtimmerman
Biotech rivalries are sometimes a bit like boxing matches, where you have two lone fighters vying for the prize. But the hepatitis C market is turning into a battle royal that’s more wide open and unpredictable, with all the competitive maneuvering, surprise crashes, and comebacks you might expect from the Daytona 500.
The medical advances in hepatitis C have been dizzying this year, especially in what it means in terms of multi-billion dollar business implications. The safest thing to say is that there’s plenty of good news for patients this year, but that shareholders in the major hepatitis C drug developers had better hold on tight as a new standard of care gets established.
Some commentators figured that Gilead Sciences (NASDAQ: GILD), the world’s biggest maker of HIV drugs, had essentially locked up the dominant position in this new drug class through its $11 billion acquisition last month of Princeton, NJ-based Pharmasset (NASDAQ: VRUS). But it’s still too soon for anyone to declare victory over the wily and fast-mutating virus that causes hepatitis C. Given the way drug development is going now, it’s possible we could have dueling antiviral drug cocktails that cure almost 100 percent of patients within five years. And before we get there, we’re going to see some fascinating chess moves—and probably a few surprising collaborations—from companies like Vertex Pharmaceuticals, Merck, Roche, Johnson & Johnson, Bristol-Myers Squibb, and Abbott Laboratories, as well as several smaller biotech startups like Alpharetta, GA-based Inhibitex (NASDAQ: INHX).
The Pharmasset compound that prompted Gilead to write such a big check, PSI-7977, is “certainly not a panacea, not the lone answer,” says Kleanthis Xanthopoulos, the CEO of San Diego-based Regulus Therapeutics, and the co-founder of another hepatitis C drug developer, Anadys Pharmaceuticals.
Regulus Therapeutics CEO Kleanthis Xanthopoulos
Xanthopoulos says Gilead was “taken to the cleaners,” and that the hepatitis C market is still up for grabs. “It’s going to take some time before people figure out how it plays out,” he says. The Pharmasset drug “is a powerful player, but you will need other direct-acting antivirals. You want to go to a 100 percent cure rate. I can guarantee the Pharmasset compound isn’t going to do it alone.”
Hepatitis C has never really captured big headlines in the U.S., as it has never benefitted from massive awareness boosting campaigns that have supported research for, say, HIV, or breast cancer. But hepatitis C has clearly emerged as one of the biggest opportunities in pharmaceuticals over the past few years. There are more than 3 million people in the U.S., and an estimated 170 million worldwide, with this liver infection that can lead to cirrhosis and liver cancer. Most people have never bothered to get treated, partly because the infection takes years to fully wreak havoc. The other reason is the standard of care with a combination of drugs—pegylated interferon alpha and ribavirin—causes flu-like symptoms that last for almost a year, and usually cures only 30-40 percent of patients. Essentially, most people figure the treatment is worse than the disease.
Vertex Pharmaceuticals changed the equation back in May. The company won FDA approval for a direct antiviral drug, a protease inhibitor called telaprevir (Incivek), that is added to the usual two-drug combo regimen. By adding the Vertex drug, researchers saw the cure rate boom to almost 80 percent of patients, while cutting the treatment time with the other drugs in half. The Vertex drug also significantly raised the cure rate for patients who failed to respond to prior rounds of therapy.
Vertex looked golden for a while, as its stock soared above $55 a share, sending its market value above $10 billion. Analysts were raving about how Vertex smashed sales expectations in its first few months on the market, and started turning profitable in just its second quarter of selling the drug. Waves of patients were suddenly showing up at doctors’ offices to get treatment for hepatitis C, now that the odds of a cure were so much higher.
But important as the Vertex advance has been, researchers have made it clear that this story isn’t over. The ultimate goal is to get rid of interferon, and its side effects, so that physicians can count on some combination of direct antivirals that can be taken as oral pills. That might include Vertex’s drug in combination with others, or might not.
So that’s why Vertex, and other companies, have feverishly been looking to mix and match various hepatitis C drugs. It’s all part of a quest to come up with the ideal combo that can raise the bar on cure rates, minimize side effects, and maximize convenience.
While people on Wall Street like to embrace a simple storyline with clear winners and losers, the hepatitis C virus is one tricky adversary. Like HIV, it has a tendency to mutate and develop resistance capabilities, whenever scientists throw a new antiviral drug against it. So there isn’t likely to be a single magic bullet. The most likely route to success is with a combination of two, three, or maybe four antiviral drugs that attack the virus from different angles, making it much harder for the bug to mutate and escape one drug.
As Steve Worland, the CEO of San Diego-based Anadys Pharmaceuticals, put it in a guest editorial for Xconomy in September, there are at least four important categories of hepatitis C antivirals. There are protease inhibitors on the market like Vertex’s drug and Merck’s boceprevir (Victrelis). There are nucleotide polymerase inhibitors like Pharmasset’s PSI-7977 and a rival drug called mericitabine from Roche. There are non-nucleotide polymerase inhibitors in the works from Abbott Laboratories, Vertex, and Anadys (which Roche acquired this fall for $230 million.) And Bristol-Myers Squibb is betting on another kind of compound, an NS5A inhibitor. (You could also count microRNA therapies, which Santaris Pharma and Regulus are working on at earlier stages of development.)
Just this year, we’ve seen some fascinating jockeying for position. Drug companies often don’t like to test combinations of experimental drugs together in clinical trials, because when side effects emerge, people often like to point the finger at the other guy’s drug. And who wants to divvy up the profits with some other pharma giant when you have the whole thing yourself?
But with hepatitis C, the market opportunity is so big, and the variety of drugs to attack it is so broad, that pharma companies have set aside those concerns just to get a piece of the action. We’ve already seen Merck and Roche form a partnership to co-market Victrelis against the leading drug on the market from Vertex. Gilead just shelled out the breathtaking sum of $11 billion for Pharmasset, even though the smaller company’s lead compound still has to navigate the third and final phase of clinical trials required for FDA approval. Bristol-Myers Squibb and Johnson & Johnson have teamed up in an interesting new collaboration. Roche, through internal efforts and acquisitions, has sought to put all the pieces of the puzzle together under one roof—a protease inhibitor, a nucleotide polymerase inhibitor, a non-nucleotide polymerase inhibitor.
Nobody knows which compounds will match up best together, which ones will be too toxic in combination, or even how many antivirals will be needed to raise the cure rate. But it’s worth noting that Vertex raised the bar very high, by getting cure rates up to around 80 percent. Doctors are certainly eager to get rid of the nasty interferon part of the regimen, but they will only do that when a new regimen can do at least as well on cure rates. And any of these drugs can be derailed by somewhat mild side effects, since the bar on safety is set quite high already.
It might be relatively safe and simple to declare Gilead/Pharmasset the winners in this market, but this race isn’t even close to over. There are 200 laps in the Daytona 500, and in the hepatitis C race, I’d say we’re at about lap 50. There are going to be some fascinating strategic maneuvers, and maybe even a spectacular crash or two, before somebody zooms in under the checkered flag.
Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com/ldtimmerman
Friday, December 9, 2011
HCV Infection May Predict Coronary Artery Disease...
I rarely post Hepatitis C disease state data because there are tons of other folks who do the same, but this caught my attention and thought it significant. It's not a prospective trial, but a decent enough 'n'. The authors found that the data "suggests that being HCV-positive increases the severity of, or risk for, CAD (Coronary Artery Disease)
NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.
"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.
To estimate the prevalence of CAD in hepatitis C patients, Dr. Satapathy and his colleagues reviewed data from 934 individuals with hepatitis C infection who were seen at a single center between May 2002 and December 2008. Of these patients, 63 had undergone coronary angiography. The investigators compared their data with data from 63 matched controls without hepatitis C.
Overall severity of CAD according to the combined Reardon severity score was significantly greater in the hepatitis C virus (HCV) group than in the controls (6.3 vs. 2.6, respectively), suggesting that being HCV-positive increases the severity of, or risk for, CAD, Dr. Satapathy said.
The researchers defined CAD in two different ways for their analysis. CAD defined as stenosis greater than 50% was found in 44 of the HCV cases (70%) compared with 30 controls (48%). CAD defined as stenosis greater than 75% was found in 42 patients with hepatitis C (67%) compared with 29 controls (46%).
In addition, the prevalence of multivessel coronary artery disease was significantly higher in the HCV patients compared with the controls (57% vs. 16%, respectively). The prevalence of single-vessel involvement was greater in the control group.
"HCV seropositive status is a strong predictor for CAD," Dr. Satapathy said. However, "HCV patients are more likely to remain undertreated with antiplatelet and lipid-lowering agents," he noted.
The study was limited by the retrospective design and small sample size, said Dr. Satapathy. However, the findings suggest that CAD is significantly more common and severe in HCV-positive patients, and this should be considered by clinicians treating these patients, he said.
Dr. Satapathy said he had no financial conflicts to disclose.
NATIONAL HARBOR, MD. – Coronary artery disease was significantly more prevalent in patients with hepatitis C virus infection, compared with control subjects, based on a retrospective review. The findings were presented at the annual meeting of the American College of Gastroenterology.
"An association of coronary artery disease [CAD] with hepatitis C has been suggested, but definitive data are still lacking," said Dr. Sanjaya Satapathy, who conducted the study while at Long Island Jewish Medical Center in New Hyde Park, N.Y.
To estimate the prevalence of CAD in hepatitis C patients, Dr. Satapathy and his colleagues reviewed data from 934 individuals with hepatitis C infection who were seen at a single center between May 2002 and December 2008. Of these patients, 63 had undergone coronary angiography. The investigators compared their data with data from 63 matched controls without hepatitis C.
Overall severity of CAD according to the combined Reardon severity score was significantly greater in the hepatitis C virus (HCV) group than in the controls (6.3 vs. 2.6, respectively), suggesting that being HCV-positive increases the severity of, or risk for, CAD, Dr. Satapathy said.
The researchers defined CAD in two different ways for their analysis. CAD defined as stenosis greater than 50% was found in 44 of the HCV cases (70%) compared with 30 controls (48%). CAD defined as stenosis greater than 75% was found in 42 patients with hepatitis C (67%) compared with 29 controls (46%).
In addition, the prevalence of multivessel coronary artery disease was significantly higher in the HCV patients compared with the controls (57% vs. 16%, respectively). The prevalence of single-vessel involvement was greater in the control group.
"HCV seropositive status is a strong predictor for CAD," Dr. Satapathy said. However, "HCV patients are more likely to remain undertreated with antiplatelet and lipid-lowering agents," he noted.
The study was limited by the retrospective design and small sample size, said Dr. Satapathy. However, the findings suggest that CAD is significantly more common and severe in HCV-positive patients, and this should be considered by clinicians treating these patients, he said.
Dr. Satapathy said he had no financial conflicts to disclose.
Vertex Pharmaceuticals begins Phase 1 studies of HCV NS5B polymerase inhibitors...
Vertex starts phase 1 trials of ALS-2200 and ALS-2158 and hopes to rapidly proceed to phase II trials. The clock is ticking on Incivek's relevance given the suggested tolerability, quality and efficacy of competitive products already in phase III development. Incivek has recently taken hits by unanticipated adverse event rumors, of which Merck is taking full advantage. Vertex has a terrific pair of CF drugs due to be reviewed soon, but the size of the market is too small to maintain current revenue. Both the Alios compounds are a bit late to the party but hopefully will differentiate themselves safely enough to successfully reach the market
Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C
BusinessWire · Dec. 9, 2011 | Last Updated: Dec. 9, 2011 8:30 AM ET
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) andAlios BioPharma, Inc.today announced the initiation of two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, which are inhibitors of the hepatitis C NS5B polymerase. The studies will evaluate the safety and tolerability of ALS-2200 and ALS-2158 in healthy volunteers followed by a seven-day evaluation to observe the effects on viral kinetics in people with chronic genotype-1 hepatitis C. Data are expected in the second quarter of 2012, which could enable the initiation of studies to evaluate multiple all-oral, interferon-free combination regimens for chronic hepatitis C in the second half of 2012. Vertex has worldwide development and commercialization rights for ALS-2200 and ALS-2158, which were discovered by Alios BioPharma. Alios and Vertex are jointly conducting the Phase 1 studies announced today.
“These studies are an important step in our ongoing efforts to strengthen our leadership position in hepatitis C by developing all-oral regimens that could further improve the future treatment of this disease,” said Peter Mueller, Ph.D., Executive Vice President, Global Research and Development, and Chief Scientific Officer for Vertex. “The studies of ALS-2200 and ALS-2158 announced today are designed to generate data that may provide the opportunity to rapidly advance into Phase 2 development where we could evaluate a number of nucleotide-based regimens beginning in the second half of next year, including regimens with INCIVEK or VX-222.”
Study Design
The two Phase 1 studies announced today will be randomized, double-blind, placebo-controlled studies. The primary goals are to evaluate the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C. A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.
Dosing is now underway for the study of ALS-2200, and dosing is expected to begin next week for the study of ALS-2158. Vertex and Alios BioPharma expect to have complete data, including seven-day viral kinetic data, from each trial in the second quarter of 2012, which could enable the initiation of all-oral, interferon-free Phase 2 combination studies in the second half of 2012. These Phase 2 studies are expected to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK (telaprevir) or VX-222, potential dual nucleotide regimens and other interferon-free combination regimens that may also include ribavirin. INCIVEK is Vertex’s FDA-approved protease inhibitor for chronic genotype-1 hepatitis C, and VX-222 is Vertex’s investigational hepatitis C non-nucleoside polymerase inhibitor. The combination studies will be designed to generate sustained viral response (SVR or viral cure) data.
About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are highly potent pan-genotypic nucleotide analogues that appear in in vitro and non-clinical studies to have a high barrier to drug resistance and the potential to be dosed orally once-daily. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound is structurally distinct and has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens, including regimens with INCIVEKTM (telaprevir) and VX-222. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in those in vitro studies,both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.
Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.
IMPORTANT SAFETY INFORMATION
Indication
INCIVEK™ (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 1,900 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.
About Alios BioPharma
Alios BioPharma is a biotechnology company located in South San Francisco, California, that is developing novel medicines aimed at the treatment of viral diseases. Alios has an innovative team of highly experienced scientists and clinical researchers who are developing direct acting antiviral agents against several human viral pathogens of public health importance including, hepatotropic and respiratory viruses and other chronic, acute and emerging viral diseases. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability. Alios is the recipient of the 2011 BayBio Pantheon Outstanding Partnering Award.
Special Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Mueller’s statements in the second paragraph of this press release and statements regarding (i) the expectation that Vertex will receive data from two Phase 1 studies in the second quarter of 2012 that could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012; (ii) the design, goals, objectives and expected timing of receiving data from the Phase 1 studies; (iii) the possible combination regimens that could be evaluated in Phase 2 studies and the potential design of such studies; and (iv) the potential for developing ALS-2200 and ALS-2158 together as a dual nucleotide regimen and as part of other combination therapy regimens. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, the possibilities that the outcomes from the Phase 1 studies may not be favorable, that the Company may not be able to successfully develop ALS-2200 or ALS-2158, and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
References:
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
(VRTX-GEN)
Contacts
Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Media:
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C
BusinessWire · Dec. 9, 2011 | Last Updated: Dec. 9, 2011 8:30 AM ET
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) andAlios BioPharma, Inc.today announced the initiation of two clinical studies for the nucleotide analogues ALS-2200 and ALS-2158, which are inhibitors of the hepatitis C NS5B polymerase. The studies will evaluate the safety and tolerability of ALS-2200 and ALS-2158 in healthy volunteers followed by a seven-day evaluation to observe the effects on viral kinetics in people with chronic genotype-1 hepatitis C. Data are expected in the second quarter of 2012, which could enable the initiation of studies to evaluate multiple all-oral, interferon-free combination regimens for chronic hepatitis C in the second half of 2012. Vertex has worldwide development and commercialization rights for ALS-2200 and ALS-2158, which were discovered by Alios BioPharma. Alios and Vertex are jointly conducting the Phase 1 studies announced today.
“These studies are an important step in our ongoing efforts to strengthen our leadership position in hepatitis C by developing all-oral regimens that could further improve the future treatment of this disease,” said Peter Mueller, Ph.D., Executive Vice President, Global Research and Development, and Chief Scientific Officer for Vertex. “The studies of ALS-2200 and ALS-2158 announced today are designed to generate data that may provide the opportunity to rapidly advance into Phase 2 development where we could evaluate a number of nucleotide-based regimens beginning in the second half of next year, including regimens with INCIVEK or VX-222.”
Study Design
The two Phase 1 studies announced today will be randomized, double-blind, placebo-controlled studies. The primary goals are to evaluate the safety and tolerability of single ascending doses of ALS-2200 and ALS-2158 in healthy volunteers and of multiple ascending doses in people with chronic genotype-1 hepatitis C. A secondary objective will be to evaluate the effects on viral kinetics of ALS-2200 and ALS-2158 during seven days of dosing in people with hepatitis C.
Dosing is now underway for the study of ALS-2200, and dosing is expected to begin next week for the study of ALS-2158. Vertex and Alios BioPharma expect to have complete data, including seven-day viral kinetic data, from each trial in the second quarter of 2012, which could enable the initiation of all-oral, interferon-free Phase 2 combination studies in the second half of 2012. These Phase 2 studies are expected to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK (telaprevir) or VX-222, potential dual nucleotide regimens and other interferon-free combination regimens that may also include ribavirin. INCIVEK is Vertex’s FDA-approved protease inhibitor for chronic genotype-1 hepatitis C, and VX-222 is Vertex’s investigational hepatitis C non-nucleoside polymerase inhibitor. The combination studies will be designed to generate sustained viral response (SVR or viral cure) data.
About ALS-2200 and ALS-2158
ALS-2200 and ALS-2158 are highly potent pan-genotypic nucleotide analogues that appear in in vitro and non-clinical studies to have a high barrier to drug resistance and the potential to be dosed orally once-daily. Both compounds are designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. Each compound is structurally distinct and has its own unique mechanism of action, which supports the potential for developing these compounds together as a dual nucleotide regimen and as part of combination therapy regimens, including regimens with INCIVEKTM (telaprevir) and VX-222. Data from in vitro studies showed that both ALS-2200 and ALS-2158 had a synergistic effect when combined together and with INCIVEK and VX-222. Additionally, in those in vitro studies,both compounds showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States.
Vertex gained worldwide rights to ALS-2200 and ALS-2158 through an exclusive worldwide licensing agreement signed with Alios BioPharma, Inc. in June 2011. The agreement also includes a research program that will focus on the discovery of additional nucleotide analogues that act on hepatitis C polymerase. Vertex has the option to select additional compounds for development emerging from the research program.
IMPORTANT SAFETY INFORMATION
Indication
INCIVEK™ (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.com.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1
Unlike HIV and hepatitis B virus, chronic hepatitis C can be cured.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8
More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada. Today, Vertex has more than 1,900 employees around the world, and Science magazine named Vertex number one on its 2011 list of Top Employers in the life sciences.
About Alios BioPharma
Alios BioPharma is a biotechnology company located in South San Francisco, California, that is developing novel medicines aimed at the treatment of viral diseases. Alios has an innovative team of highly experienced scientists and clinical researchers who are developing direct acting antiviral agents against several human viral pathogens of public health importance including, hepatotropic and respiratory viruses and other chronic, acute and emerging viral diseases. The overall goal for the Alios therapeutic platform is to maximize patient benefits in areas of high unmet medical need through optimization of potency, safety and tolerability. Alios is the recipient of the 2011 BayBio Pantheon Outstanding Partnering Award.
Special Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including Dr. Mueller’s statements in the second paragraph of this press release and statements regarding (i) the expectation that Vertex will receive data from two Phase 1 studies in the second quarter of 2012 that could enable initiation of interferon-free, nucleotide-based combination studies in the second half of 2012; (ii) the design, goals, objectives and expected timing of receiving data from the Phase 1 studies; (iii) the possible combination regimens that could be evaluated in Phase 2 studies and the potential design of such studies; and (iv) the potential for developing ALS-2200 and ALS-2158 together as a dual nucleotide regimen and as part of other combination therapy regimens. While the Company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, the possibilities that the outcomes from the Phase 1 studies may not be favorable, that the Company may not be able to successfully develop ALS-2200 or ALS-2158, and the other risks listed under Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the Company's website at www.vrtx.com. The Company disclaims any obligation to update the information contained in this press release as new information becomes available.
References:
1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.
2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.
3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.
4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.
5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.
7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).
8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.
9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.
11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.
12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.
(VRTX-GEN)
Contacts
Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
Media:
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
Thursday, December 8, 2011
HCV p7 inhibitor BIT225 posts strong EVR results....
...but is it viable in the new zeitgeist of interferon-free therapies?
Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.
Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.
Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.
This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.
The extent of virus reduction was dose-dependent, with the higher dose having the most effect.
Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.
Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.
Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.
Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.
Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.
Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.
Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.
This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.
The extent of virus reduction was dose-dependent, with the higher dose having the most effect.
Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.
Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.
Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.
Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.
Tuesday, December 6, 2011
Dendreon Corporation sells it's royalty stream for Victrelis...
Dendreon Selling Royalty Interest Of Hepatitis C Treatment To Boost Cash Position
Tuesday, December 06, 2011 1:07 PM
Dendreon Corp. (NASDAQ:DNDN),a biotechnology company, has agreed to sell its royalty interest associated with VICTRELIS, a treatment for chronic hepatitis C, for $125 million to boost its cash position.
The intellectual property related to VICTRELIS was co-developed by Corvas International, Inc. and Merck's unit Schering and, was acquired by Dendreon in July 2003.
The royalty interest was acquired by CPPIB Credit Investments Inc., a subsidiary of Toronto-based CPP Investment Board (CPPIB).
The transaction is expected to close this month.
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011. Dendreon’s first product, PROVENGE was approved by the FDA in April 2010.
Seattle, Washington-based Dendreon is trading unchanged at $8.80 at 12.35 pm EST. The stock has been trading in the 52-week range between $6.46 and $43.96.
Tuesday, December 06, 2011 1:07 PM
Dendreon Corp. (NASDAQ:DNDN),a biotechnology company, has agreed to sell its royalty interest associated with VICTRELIS, a treatment for chronic hepatitis C, for $125 million to boost its cash position.
The intellectual property related to VICTRELIS was co-developed by Corvas International, Inc. and Merck's unit Schering and, was acquired by Dendreon in July 2003.
The royalty interest was acquired by CPPIB Credit Investments Inc., a subsidiary of Toronto-based CPP Investment Board (CPPIB).
The transaction is expected to close this month.
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011. Dendreon’s first product, PROVENGE was approved by the FDA in April 2010.
Seattle, Washington-based Dendreon is trading unchanged at $8.80 at 12.35 pm EST. The stock has been trading in the 52-week range between $6.46 and $43.96.
Zacks Investment Research on HCV market....
Zacks analysis of the current HCV market and speculation of what's to come. Interesting read especially if you're new to the HCV drug development space.
Spotlight On Hepatitis-C Market
By Zacks Investment Research on December 6, 2011
Is the hepatitis-C market the next Mecca for the pharma/biotech sector? It seems so if we go by the flurry of activity and heightened interest in this market in the past few quarters. The hepatitis-C virus (HCV) market seems to have caught the eye of several pharma/biotech companies – as evident by the deals being signed for the development of drugs for the treatment of HCV.
We are talking about the recent announcements made by big players like Johnson & Johnson (NYSE:JNJ), Bristol-Myers Squibb (NYSE:BMY) and Gilead Sciences, Inc. (NASDAQ:GILD). All three companies have made it clear they want a piece of the HCV market pie.
Johnson & Johnson’s Tibotec Pharmaceuticals and Bristol-Myers Squibb recently announced that they have decided to join forces for the development of Bristol-Myers’ daclatasvir (BMS-790052) in combination with Tibotec’s TMC435, for the treatment of chronic HCV. What the partners are aiming to do is create an oral once-daily interferon-free cocktail treatment for HCV patients.
Bristol-Myers and Johnson & Johnson’s announcement comes on the heels of Gilead’s announcement regarding its intention to buy Pharmasset, Inc. (NASDAQ:VRUS), a company focused on developing HCV treatments. We think the main attraction for Gilead in this $11 billion deal is Pharmasset’s HCV pipeline. Lead candidate PSI-7977 is currently in two phase III studies, with a third phase III study scheduled to commence in the first half of 2012. Successful development could lead to US approval in 2014 thereby making Gilead a front-runner in the oral once-daily interferon-free cocktail treatment HCV market.
We note that both TMC435 and daclatasvir are being evaluated separately in combination with Pharmasset’s PSI-7977.
The Allure of the HCV Market
HCV is a hot development area which has come into the limelight with the launch of two new treatments – Vertex Pharmaceuticals’ (NASDAQ:VRTX) Incivek and Merck’s (NYSE:MRK) Victrelis. Both drugs gained approval in the US earlier this year. Incivek, which was launched in May 2011, posted a whopping $419.6 million in sales in the first full quarter of its launch.
So, with two new recently launched products in the market, why is the HCV market considered so attractive? Firstly, it is estimated that about 170 million people suffer from HCV infection across the world. However, the treated population is much lower. In major markets like the US, EU, Japan, Australia, Turkey, Canada, etc. only 200,000 HCV patients out of a total of more than 12 million are estimated to receive treatment each year. This means a huge number of HCV patients go untreated, leaving the field open for new treatments.
Secondly, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment. A 48-week course of both peg-interferon (peg-INF – weekly injections) and ribavirin (RBV – oral drug), are the standard treatment for genotype 1 HCV infection. However, this treatment regimen is associated with significant side-effects like fatigue, flu-like symptoms, rash, depression and anemia.
With a large number of HCV patients failing to achieve a sustained viral response (SVR) on the current standard of care, there are several patients who would be open to treatment with new and potentially more effective therapies.
These factors have made the HCV market an attractive commercial opportunity for pharma and biotech companies. Victrelis and Incivek are examples of the changing treatment regimen in the HCV market. Both are protease inhibitors which when added to the standard of care reduce the treatment period and also improve the treatment outcome. However, both need to be administered with peg-IFN and RBV – this leaves the path open for the introduction of treatments with fewer side effects.
Cocktail Therapy – The Next Big Thing in HCV
Companies like Johnson & Johnson and Gilead are trying to develop the next crop of drugs, which are expected to change the treatment paradigm for HCV patients by providing them with all-oral treatment regimens. The aim is to develop a treatment which does not require the administration of interferon, thereby doing away with a whole range of side effects. The treatment duration will also be shorter.
Treatments being developed include HCV polymerase inhibitors and HCV NS5A inhibitors. The future HCV market will most likely consist of cocktail treatment regimens developed by combining different oral treatments.
Vertex Pharma has also recognized the need to continually evolve the HCV treatment pattern and is developing an all-oral combination of VX-222 (a polymerase inhibitor) and Incivek without peg-IFN.
Who Will Win the Rat Race?
With several companies pursuing cocktail therapies for HCV, it will be interesting to see which of these companies will be the first to hit the market with a new treatment option. Currently, it looks like Gilead might be the front-runner assuming the Pharmasset acquisition goes through.
Spotlight On Hepatitis-C Market
By Zacks Investment Research on December 6, 2011
Is the hepatitis-C market the next Mecca for the pharma/biotech sector? It seems so if we go by the flurry of activity and heightened interest in this market in the past few quarters. The hepatitis-C virus (HCV) market seems to have caught the eye of several pharma/biotech companies – as evident by the deals being signed for the development of drugs for the treatment of HCV.
We are talking about the recent announcements made by big players like Johnson & Johnson (NYSE:JNJ), Bristol-Myers Squibb (NYSE:BMY) and Gilead Sciences, Inc. (NASDAQ:GILD). All three companies have made it clear they want a piece of the HCV market pie.
Johnson & Johnson’s Tibotec Pharmaceuticals and Bristol-Myers Squibb recently announced that they have decided to join forces for the development of Bristol-Myers’ daclatasvir (BMS-790052) in combination with Tibotec’s TMC435, for the treatment of chronic HCV. What the partners are aiming to do is create an oral once-daily interferon-free cocktail treatment for HCV patients.
Bristol-Myers and Johnson & Johnson’s announcement comes on the heels of Gilead’s announcement regarding its intention to buy Pharmasset, Inc. (NASDAQ:VRUS), a company focused on developing HCV treatments. We think the main attraction for Gilead in this $11 billion deal is Pharmasset’s HCV pipeline. Lead candidate PSI-7977 is currently in two phase III studies, with a third phase III study scheduled to commence in the first half of 2012. Successful development could lead to US approval in 2014 thereby making Gilead a front-runner in the oral once-daily interferon-free cocktail treatment HCV market.
We note that both TMC435 and daclatasvir are being evaluated separately in combination with Pharmasset’s PSI-7977.
The Allure of the HCV Market
HCV is a hot development area which has come into the limelight with the launch of two new treatments – Vertex Pharmaceuticals’ (NASDAQ:VRTX) Incivek and Merck’s (NYSE:MRK) Victrelis. Both drugs gained approval in the US earlier this year. Incivek, which was launched in May 2011, posted a whopping $419.6 million in sales in the first full quarter of its launch.
So, with two new recently launched products in the market, why is the HCV market considered so attractive? Firstly, it is estimated that about 170 million people suffer from HCV infection across the world. However, the treated population is much lower. In major markets like the US, EU, Japan, Australia, Turkey, Canada, etc. only 200,000 HCV patients out of a total of more than 12 million are estimated to receive treatment each year. This means a huge number of HCV patients go untreated, leaving the field open for new treatments.
Secondly, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment. A 48-week course of both peg-interferon (peg-INF – weekly injections) and ribavirin (RBV – oral drug), are the standard treatment for genotype 1 HCV infection. However, this treatment regimen is associated with significant side-effects like fatigue, flu-like symptoms, rash, depression and anemia.
With a large number of HCV patients failing to achieve a sustained viral response (SVR) on the current standard of care, there are several patients who would be open to treatment with new and potentially more effective therapies.
These factors have made the HCV market an attractive commercial opportunity for pharma and biotech companies. Victrelis and Incivek are examples of the changing treatment regimen in the HCV market. Both are protease inhibitors which when added to the standard of care reduce the treatment period and also improve the treatment outcome. However, both need to be administered with peg-IFN and RBV – this leaves the path open for the introduction of treatments with fewer side effects.
Cocktail Therapy – The Next Big Thing in HCV
Companies like Johnson & Johnson and Gilead are trying to develop the next crop of drugs, which are expected to change the treatment paradigm for HCV patients by providing them with all-oral treatment regimens. The aim is to develop a treatment which does not require the administration of interferon, thereby doing away with a whole range of side effects. The treatment duration will also be shorter.
Treatments being developed include HCV polymerase inhibitors and HCV NS5A inhibitors. The future HCV market will most likely consist of cocktail treatment regimens developed by combining different oral treatments.
Vertex Pharma has also recognized the need to continually evolve the HCV treatment pattern and is developing an all-oral combination of VX-222 (a polymerase inhibitor) and Incivek without peg-IFN.
Who Will Win the Rat Race?
With several companies pursuing cocktail therapies for HCV, it will be interesting to see which of these companies will be the first to hit the market with a new treatment option. Currently, it looks like Gilead might be the front-runner assuming the Pharmasset acquisition goes through.
Monday, December 5, 2011
BioMedReports.com on Idenix... everything you wanted to know and then a little bit more...
For those of you who love to indulge themselves with HCV drug development minutia (meaning nerds like me) here is a nice investment piece from Proactive Investors.com, specifically a Biomed report on Idenix.
When it comes to Idenix, who are you betting with?
Mon 3:45 pm by M.E. Garza
Even if you're late to the break-out party, Idenix Pharmaceuticals (NASDAQ:IDIX) is still an intriguing market mover worth watching.
On Thursday, we told our subscribers that shares of Idenix had seen over $200K worth of insider buying during the month of November- making it one of the most purchased stocks by insiders in biotech. By Friday, the stock broke out and led all gainers in healthcare after shares traded as high as $8.51 before closing 8% higher at $8.22 +0.62.
Idenix Pharmaceuticals, Inc.
7.60 -0.62 (-7.54%)
Shares of Idenix Pharmaceuticals hit new highs after 1,221,246 traded hands (148% of the daily average). Still, it appears a growing number of traders are starting to feel that IDIX shares are now overbought as 5.2M of the stocks 56.5M shares are now positioned to the short side. With Idenix now priced more than 25% above its average consensus analyst price target, who could blame them? Still, there is more to this equation.
Investors who are long the stock may be a little on edge after the 42.73 % Daily Short Sale Volume on Friday. This figure was calculated using the daily aggregate reported share volume of executed short sale trades during regular trading hours and the daily aggregate reported share volume of all executed trades during regular trading hours. That being said, the shorts have approximately six days to cover their positions, so if any important news or developments are announced during that time we could see some heavy covering.
As we look at the BioMedReports FDA Calendar and World Wide Regulatory Catalyst Tracker for hints of any pending news, we see several listed milestones which are supposed to take place in the short term and could come into play to catch shorts off-guard.
For example, one of those catalysts involves an announcement made in early August, in which Idenix stated that it had selected IDX719 as the lead candidate for its NS5A program. The NS5A program is another focus of Idenix’s Hepatitis C virus (HCV) discovery efforts. The company states that it has identified NS5A compounds with multi-genotypic activity and favorable pharmacokinetics. Two candidates have been selected for preclinical development, their website as well as a recently filed SEC document indicate that the company plans to file an IND.
IDX719 showed potent activity and broad genotypic coverage in preclinical studies. The planned Investigational New Drug application remains on track, and the Company expects to submit regulatory filings by year-end 2011 and begin the clinical program in early 2012.
Idenix shares are trading much higher than their levels of support at the 50-day ($6.02) and 200-day moving averages ($5.05). Both of those averages have moved 1.82% higher and 2.38% higher over the past week, and shares are now trading 59% higher than when we told our readers (on October 18th) that Hepatitis C drug developers were seeing shares rise after Swiss drugmaker Roche agreed to buy Anadys Pharmaceuticals (Nasdaq:ANDS) for $230 million. IDIX shares were then priced at $5.51 per share.
Idenix is engaged in the discovery and development of drugs for the treatment of human viral diseases. Like shares of Achillion Pharmaceuticals (NASDAQ:ACHN) and Inhibitex (NASDAQ:INHX), IDIX shares have continued to climb much higher in the last couple of months.
Idenix has a robust pipeline focused on agents for advance treatment of hepatitis C. As we mentioned, they have an ongoing HCV development and discovery program building a critical mass of candidates in three different classes of drugs, including: nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors.
Its pipeline products include: IDX375, a lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program, IDX136, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C, IDX316, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C. etc. The company co-developed and co-launched the licensed hepatitis B drug candidate, Telbivudine. The firm has collaborations with Novartis Pharma AG, ViiV Healthcare, GlaxoSmithKline plc, Sareum Ltd, Galapagos nv, Microbiologica Quimica e Farmaceutica, Ltda., Institut Pasteur, National Center for Scientific Research (CNRS), and others.
From a financial perspective, in the firm's November 10Q filing, management stated "We believe that our current cash, cash equivalents and the expected royalty payments associated with product sales of Tyzeka®/Sebivo® will be sufficient to sustain operations into at least the second quarter of 2012." In mid November, Idenix announced the pricing of an underwritten registered public offering of 9,393,416 shares of its common stock at a public offering price of USD 6.50 per share. All of the shares were sold by Idenix.
Prior to that, in early April, Idenix Pharmaceuticals, Inc. announced the pricing of an underwritten registered public offering of 18,310,000 shares of its common stock at a public offering price of USD $2.80 per share.
As reported by the Motley Fool when shares rose on Friday, IDX184 is Idenix's greatest hope for a future blockbuster and the drug candidate is currently in phase 2b trials. "The oral drug is designed to enhance the efficiency of other medications. Idenix doesn't have a big-name partner for the endgame yet and might end up arm-in-arm with J&J or Bristol-Myers."
Disclosure: None
When it comes to Idenix, who are you betting with?
Mon 3:45 pm by M.E. Garza
Even if you're late to the break-out party, Idenix Pharmaceuticals (NASDAQ:IDIX) is still an intriguing market mover worth watching.
On Thursday, we told our subscribers that shares of Idenix had seen over $200K worth of insider buying during the month of November- making it one of the most purchased stocks by insiders in biotech. By Friday, the stock broke out and led all gainers in healthcare after shares traded as high as $8.51 before closing 8% higher at $8.22 +0.62.
Idenix Pharmaceuticals, Inc.
7.60 -0.62 (-7.54%)
Shares of Idenix Pharmaceuticals hit new highs after 1,221,246 traded hands (148% of the daily average). Still, it appears a growing number of traders are starting to feel that IDIX shares are now overbought as 5.2M of the stocks 56.5M shares are now positioned to the short side. With Idenix now priced more than 25% above its average consensus analyst price target, who could blame them? Still, there is more to this equation.
Investors who are long the stock may be a little on edge after the 42.73 % Daily Short Sale Volume on Friday. This figure was calculated using the daily aggregate reported share volume of executed short sale trades during regular trading hours and the daily aggregate reported share volume of all executed trades during regular trading hours. That being said, the shorts have approximately six days to cover their positions, so if any important news or developments are announced during that time we could see some heavy covering.
As we look at the BioMedReports FDA Calendar and World Wide Regulatory Catalyst Tracker for hints of any pending news, we see several listed milestones which are supposed to take place in the short term and could come into play to catch shorts off-guard.
For example, one of those catalysts involves an announcement made in early August, in which Idenix stated that it had selected IDX719 as the lead candidate for its NS5A program. The NS5A program is another focus of Idenix’s Hepatitis C virus (HCV) discovery efforts. The company states that it has identified NS5A compounds with multi-genotypic activity and favorable pharmacokinetics. Two candidates have been selected for preclinical development, their website as well as a recently filed SEC document indicate that the company plans to file an IND.
IDX719 showed potent activity and broad genotypic coverage in preclinical studies. The planned Investigational New Drug application remains on track, and the Company expects to submit regulatory filings by year-end 2011 and begin the clinical program in early 2012.
Idenix shares are trading much higher than their levels of support at the 50-day ($6.02) and 200-day moving averages ($5.05). Both of those averages have moved 1.82% higher and 2.38% higher over the past week, and shares are now trading 59% higher than when we told our readers (on October 18th) that Hepatitis C drug developers were seeing shares rise after Swiss drugmaker Roche agreed to buy Anadys Pharmaceuticals (Nasdaq:ANDS) for $230 million. IDIX shares were then priced at $5.51 per share.
Idenix is engaged in the discovery and development of drugs for the treatment of human viral diseases. Like shares of Achillion Pharmaceuticals (NASDAQ:ACHN) and Inhibitex (NASDAQ:INHX), IDIX shares have continued to climb much higher in the last couple of months.
Idenix has a robust pipeline focused on agents for advance treatment of hepatitis C. As we mentioned, they have an ongoing HCV development and discovery program building a critical mass of candidates in three different classes of drugs, including: nucleoside polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors.
Its pipeline products include: IDX375, a lead clinical candidate from its HCV non-nucleoside polymerase inhibitor discovery program, IDX136, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C, IDX316, a novel macrocyclic HCV protease inhibitor being developed as oral formulation for the treatment of Hepatitis C. etc. The company co-developed and co-launched the licensed hepatitis B drug candidate, Telbivudine. The firm has collaborations with Novartis Pharma AG, ViiV Healthcare, GlaxoSmithKline plc, Sareum Ltd, Galapagos nv, Microbiologica Quimica e Farmaceutica, Ltda., Institut Pasteur, National Center for Scientific Research (CNRS), and others.
From a financial perspective, in the firm's November 10Q filing, management stated "We believe that our current cash, cash equivalents and the expected royalty payments associated with product sales of Tyzeka®/Sebivo® will be sufficient to sustain operations into at least the second quarter of 2012." In mid November, Idenix announced the pricing of an underwritten registered public offering of 9,393,416 shares of its common stock at a public offering price of USD 6.50 per share. All of the shares were sold by Idenix.
Prior to that, in early April, Idenix Pharmaceuticals, Inc. announced the pricing of an underwritten registered public offering of 18,310,000 shares of its common stock at a public offering price of USD $2.80 per share.
As reported by the Motley Fool when shares rose on Friday, IDX184 is Idenix's greatest hope for a future blockbuster and the drug candidate is currently in phase 2b trials. "The oral drug is designed to enhance the efficiency of other medications. Idenix doesn't have a big-name partner for the endgame yet and might end up arm-in-arm with J&J or Bristol-Myers."
Disclosure: None
Achillion Pharmaceuticals announces preliminary proof-of-concept data with HCV NS5A inhibitor ACH-2928...
Looks like Achillion Pharmaceuticals' NS5A inhibitor is bearing fruit, with the company releasing three-day monotherapy proof-of-concept data for it's first generation NS5A inhibitor ACH-2928 as well as naming a second generation compound ACH-3102, which is slated for early trials in Q1/Q2 next year. CE0 Michael D. Kishbauch is aiming for "a proprietary interferon-free DAA combination regimen for the treatment of HCV within Achillion's pipeline." Looks like Achillion will have plenty to present at EASL 2012, as well as an intention to evaluate an all-oral comb including one of their protease inhibitors and an NS5A inhibitors.
Achillion Announces Preliminary Phase 1b Proof-of-Concept Data With ACH-2928 NS5A Inhibitor for the Treatment of Hepatitis C
Achieves 3.68 Log10 Reduction in HCV RNA After Three Days of Treatment
NEW HAVEN, Conn., Dec 5, 2011 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. ACHN +1.61% , a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported proof-of-concept data from its Phase 1b clinical trial of ACH-2928, a first-generation NS5A inhibitor, demonstrating that patients treated with ACH-2928 achieved a mean maximum 3.68 log10 reduction in HCV RNA after three-day monotherapy of 60 mg once daily. The compound also demonstrated good safety and tolerability both in healthy volunteers and in patients with chronic hepatitis C (HCV).
ACH-2928, Achillion's first generation inhibitor of the NS5A protein, was discovered through the Company's NS5A inhibitor program. Achillion also recently nominated a second-generation NS5A inhibitor, ACH-3102, which is currently undergoing IND-enabling studies and is expected to be advanced into clinical trials during the first half of 2012.
"We believe NS5A inhibitors have emerged as an important component for an all-oral, direct acting antiviral (DAA) regimen," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, NS5A inhibitors, when combined with a protease inhibitor, have achieved sustained viral responses in clinical trials in tough to treat genotype 1 HCV populations. We believe this highlights the potential to form a proprietary interferon-free DAA combination regimen for the treatment of HCV within Achillion's pipeline."
ACH-2928 Phase 1 Program
In July 2011, Achillion initiated dosing in a randomized, double-blind, placebo-controlled phase 1a/1b clinical trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2928. The trial consists of three segments: assessment of single ascending oral doses (SAD) in healthy volunteers, evaluation of 3 days of oral repeat doses in subjects with genotype 1a or 1b HCV, and a 5-day multiple ascending doses segment in healthy volunteers.
During the oral repeat doses segment in subjects infected with HCV, a total of 10 patients were enrolled with 2 patients (genotype 1a) receiving placebo and 8 patients (7 genotype 1a and 1 genotype 1b) treated with 3 doses of 60 mg ACH-2928 administered once daily. No serious adverse events (SAE) were reported and there were no patient discontinuations during treatment. The mean maximum HCV RNA decline during therapy was 3.68 log10 compared to a 0.54 log10 decline for patients receiving placebo. There were no viral breakthroughs observed during ACH-2928 monotherapy.
Preliminary data from the SAD trial segment demonstrated ACH-2928 was well tolerated at all doses evaluated up to and including the maximum dose of 500 mg. There were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, and were transient in nature.
Based upon these preliminary results, the ongoing Phase 1 study will continue to evaluate the pharmacokinetic, pharmacodynamic, and antiviral profile of ACH-2928. These Phase 1 results have been submitted for presentation at a medical meeting being held during the second quarter of 2012. In parallel, Achillion is advancing its second generation NS5A inhibitor ACH-3102 through IND-enabling studies and the Company expects to initiate clinical development during the first half of 2012.
"As we continue to evaluate ACH-2928 in this Phase 1 study, we are also working rapidly to advance ACH-3102, which has shown in preclinical studies to possess the same potent activity against genotype 1a HCV as ACH-2928, as well as enhanced activity against resistant HCV mutants that have been observed in this patient population," stated Milind Deshpande, PhD, President of Research and Development and Chief Scientific Officer. "We believe these results validate our NS5A development program, and look forward to developing an all-oral combination for clinical evaluation that includes one of our protease inhibitors and an NS5A inhibitor next year."
About NS5A Inhibitors
The NS5A protein is a clinically validated target that serves multiple functions at various stages of the HCV life cycle including involvement in virion production, interaction with host proteins and association with interferon-resistance. Achillion's NS5A inhibitors, including ACH-2928 and ACH-3102, possess potent in vitro activity against all HCV genotypes and demonstrate, in preclinical studies, additive to synergistic activity when combined with NS3 protease inhibitors, NS5B polymerase inhibitors, and ribavirin. In preclinical studies, ACH-2928 and ACH-3102 have demonstrated excellent potency, in the pico-molar range, against HCV RNA replication, including potent activity against genotype 1a while ACH-3102 has been shown to possess enhanced activity against recognized genotype 1 resistant variants.
About HCV
The hepatitis C virus infects the liver and is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80 percent of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors, including statements with respect to the potency, safety and other characteristics of Achillion's NS5A inhibitors, which may not be duplicated in clinical studies, and Achillion's expectations regarding results, timing and duration of clinical trials and reporting of results from clinical trials of Achillion's NS5A inhibitors. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to: Achillion's ability to advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; to obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; to establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agreements with appropriate third-parties; and to raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
Achillion Announces Preliminary Phase 1b Proof-of-Concept Data With ACH-2928 NS5A Inhibitor for the Treatment of Hepatitis C
Achieves 3.68 Log10 Reduction in HCV RNA After Three Days of Treatment
NEW HAVEN, Conn., Dec 5, 2011 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. ACHN +1.61% , a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today reported proof-of-concept data from its Phase 1b clinical trial of ACH-2928, a first-generation NS5A inhibitor, demonstrating that patients treated with ACH-2928 achieved a mean maximum 3.68 log10 reduction in HCV RNA after three-day monotherapy of 60 mg once daily. The compound also demonstrated good safety and tolerability both in healthy volunteers and in patients with chronic hepatitis C (HCV).
ACH-2928, Achillion's first generation inhibitor of the NS5A protein, was discovered through the Company's NS5A inhibitor program. Achillion also recently nominated a second-generation NS5A inhibitor, ACH-3102, which is currently undergoing IND-enabling studies and is expected to be advanced into clinical trials during the first half of 2012.
"We believe NS5A inhibitors have emerged as an important component for an all-oral, direct acting antiviral (DAA) regimen," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, NS5A inhibitors, when combined with a protease inhibitor, have achieved sustained viral responses in clinical trials in tough to treat genotype 1 HCV populations. We believe this highlights the potential to form a proprietary interferon-free DAA combination regimen for the treatment of HCV within Achillion's pipeline."
ACH-2928 Phase 1 Program
In July 2011, Achillion initiated dosing in a randomized, double-blind, placebo-controlled phase 1a/1b clinical trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2928. The trial consists of three segments: assessment of single ascending oral doses (SAD) in healthy volunteers, evaluation of 3 days of oral repeat doses in subjects with genotype 1a or 1b HCV, and a 5-day multiple ascending doses segment in healthy volunteers.
During the oral repeat doses segment in subjects infected with HCV, a total of 10 patients were enrolled with 2 patients (genotype 1a) receiving placebo and 8 patients (7 genotype 1a and 1 genotype 1b) treated with 3 doses of 60 mg ACH-2928 administered once daily. No serious adverse events (SAE) were reported and there were no patient discontinuations during treatment. The mean maximum HCV RNA decline during therapy was 3.68 log10 compared to a 0.54 log10 decline for patients receiving placebo. There were no viral breakthroughs observed during ACH-2928 monotherapy.
Preliminary data from the SAD trial segment demonstrated ACH-2928 was well tolerated at all doses evaluated up to and including the maximum dose of 500 mg. There were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, and were transient in nature.
Based upon these preliminary results, the ongoing Phase 1 study will continue to evaluate the pharmacokinetic, pharmacodynamic, and antiviral profile of ACH-2928. These Phase 1 results have been submitted for presentation at a medical meeting being held during the second quarter of 2012. In parallel, Achillion is advancing its second generation NS5A inhibitor ACH-3102 through IND-enabling studies and the Company expects to initiate clinical development during the first half of 2012.
"As we continue to evaluate ACH-2928 in this Phase 1 study, we are also working rapidly to advance ACH-3102, which has shown in preclinical studies to possess the same potent activity against genotype 1a HCV as ACH-2928, as well as enhanced activity against resistant HCV mutants that have been observed in this patient population," stated Milind Deshpande, PhD, President of Research and Development and Chief Scientific Officer. "We believe these results validate our NS5A development program, and look forward to developing an all-oral combination for clinical evaluation that includes one of our protease inhibitors and an NS5A inhibitor next year."
About NS5A Inhibitors
The NS5A protein is a clinically validated target that serves multiple functions at various stages of the HCV life cycle including involvement in virion production, interaction with host proteins and association with interferon-resistance. Achillion's NS5A inhibitors, including ACH-2928 and ACH-3102, possess potent in vitro activity against all HCV genotypes and demonstrate, in preclinical studies, additive to synergistic activity when combined with NS3 protease inhibitors, NS5B polymerase inhibitors, and ribavirin. In preclinical studies, ACH-2928 and ACH-3102 have demonstrated excellent potency, in the pico-molar range, against HCV RNA replication, including potent activity against genotype 1a while ACH-3102 has been shown to possess enhanced activity against recognized genotype 1 resistant variants.
About HCV
The hepatitis C virus infects the liver and is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80 percent of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors, including statements with respect to the potency, safety and other characteristics of Achillion's NS5A inhibitors, which may not be duplicated in clinical studies, and Achillion's expectations regarding results, timing and duration of clinical trials and reporting of results from clinical trials of Achillion's NS5A inhibitors. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to: Achillion's ability to advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; to obtain patent protection for its drug candidates, and the freedom to operate under third party intellectual property; to establish commercial manufacturing arrangements and to identify, enter into and maintain collaboration agreements with appropriate third-parties; and to raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Achillion Pharmaceuticals, Inc.
CONTACT: Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com
Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com
Media:
Christin Culotta Miller
Ogilvy PR
Tel. (212) 880-5264
christin.miller@ogilvy.com
Friday, December 2, 2011
BMS and Tibotec team up HCV antivirals for phase II trial....
The HCV development partnership space is jumpin'! Medivir/Tibotec now has two partnerships, one with Gilead/Pharmasset in combination with their nuc PSI-7977 and now with BMS's daclatasvir. The question of what happens to the development of BMS's peg lambda is still a bit of a mystery.
December 02, 2011 07:30 AM Eastern Time
Bristol-Myers Squibb Enters Clinical Collaboration Agreement with Tibotec Pharmaceuticals for Phase II Combination Study in Patients Chronically Infected with Hepatitis C
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).
Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels, senior vice president, Development. “We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy.”
About daclatasvir (BMS-790052)
Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir is the first NS5A replication complex inhibitor to be investigated in clinical trials and is currently in Phase III development. Daclatasvir is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from early stage development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contacts
Bristol-Myers Squibb
Media:
Jennifer Fron Mauer, 609-252-6579
jennifer.mauer@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
or
Teri Loxam, 609-252-3368
teri.loxam@bms.com
Company Information Center
Bristol-Myers Squibb Company
NYSE:BMY
December 02, 2011 07:30 AM Eastern Time
Bristol-Myers Squibb Enters Clinical Collaboration Agreement with Tibotec Pharmaceuticals for Phase II Combination Study in Patients Chronically Infected with Hepatitis C
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).
Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
“Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV,” said Brian Daniels, senior vice president, Development. “We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy.”
About daclatasvir (BMS-790052)
Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir is the first NS5A replication complex inhibitor to be investigated in clinical trials and is currently in Phase III development. Daclatasvir is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the compound described in this release will move from early stage development into full product development, that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or become a commercially successful product. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contacts
Bristol-Myers Squibb
Media:
Jennifer Fron Mauer, 609-252-6579
jennifer.mauer@bms.com
or
Investors:
John Elicker, 609-252-4611
john.elicker@bms.com
or
Teri Loxam, 609-252-3368
teri.loxam@bms.com
Company Information Center
Bristol-Myers Squibb Company
NYSE:BMY
Thursday, December 1, 2011
Journal article in Hepatology on green tea flavonoid that may prevent HCV reinfection post-liver transplant...
Some promising news published online in the journal Hepatology discussing in vivo research on the green tea catechin epigallocatechin-3-gallate (EGCG) that could possibly block HCV viral attachment to hepatocytes to prevent hepatitis C reinfection post-transplant.
Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Green tea flavonoid may prevent reinfection with hepatitis C virus following liver transplantation
German researchers have determined that epigallocatechin-3-gallate (EGCG)—a flavonoid found in green tea—inhibits the hepatitis C virus (HCV) from entering liver cells. Study findings available in the December issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, suggest that EGCG may offer an antiviral strategy to prevent HCV reinfection following liver transplantation.
HCV infection can lead to chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC) or primary liver cancer. HCV is one of the most common causes of chronic liver disease and a primary indication for liver transplantation, affecting up to 170 million individuals worldwide according to estimates from the World Health Organization (WHO). Prior studies report that nearly 2% of the world population is infected with chronic HCV and up to 20% of the population in some countries.
While standard treatment with interferon with ribavirin and newer protease inhibitors may clear infection in some individuals, a substantial number of patients still may not respond to these therapies. For individuals receiving liver transplants due to complications from HCV, reinfection of the healthy donor liver remains a significant concern. Antiviral strategies that target HCV in its early stages are urgently needed to prevent graft reinfection and improve long-term outcomes for patients.
To address this critical issue, Dr. Sandra Ciesek and Dr. Eike Steinmann from the Hannover Medical School in Germany investigated the effect of the EGCG molecule, which is a major component of green tea, in preventing HCV from attaching to liver cells. "Green tea catechins such as EGCG and its derivatives epigallocatechin (EGC), epicatechingallate (ECG), and epicatechin (EC) have been shown to exhibit antiviral and anti-oncogenic properties," explains Dr. Ciesek. "Our study further explores the potential effect these flavonoids have in preventing HCV reinfection following liver transplantation."
Results showed that unlike its derivatives, EGCG inhibits entry of HCV into liver cells. The authors suggest that EGCG may impede HCV cell entry by acting on the host cell as the green tea catechin was not found to alter the density of virus particles. Pretreatment of cells with EGCG before HCV inoculation did not reduce the infection; however application during inoculation inhibited the rapid spread of the HCV. Lastly, researchers showed that EGCG inhibits viral attachment—the initial step in the HCV infection process. "The green tea antioxidant EGCG inhibits HCV cell entry by blocking viral attachment and may offer a new approach to prevent HCV infection, particularly reinfection following liver transplantation." concludes Dr. Ciesek.
###
Full Citation: The Green Tea Polyphenol Epigallocatechin-3-Gallate (EGCG) Inhibits Hepatitis C Virus (HCV) Entry." Sandra Ciesek, Thomas von Hahn, Che C. Colpitts, Luis M Schang,Martina Friesland, Jörg Steinmann, Michael P. Manns, Michael Ott, Heiner Wedemeyer, Philip Meuleman, Thomas Pietschmann and Eike Steinmann. Hepatology; Published Online: November 30, 2011 (DOI: 10.1002/hep.24610); Print Issue Date: December 2011. http://onlinelibrary.wiley.com/doi/10.1002/hep.24610/abstract.
Author Contact: To arrange an interview with Dr. Sandra Ciesek or Dr. Eike Steinmann, please contact Jo Schilling at jo.schilling@twincore.de.
This study is published in Hepatology. Media wishing to receive a PDF of the article may contact healthnews@wiley.com.
About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Hepatology's current impact factor is 10.885.Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350 .
About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.
Contact: Dawn Peters
healthnews@wiley.com
781-388-8408
Wiley-Blackwell
Green tea flavonoid may prevent reinfection with hepatitis C virus following liver transplantation
German researchers have determined that epigallocatechin-3-gallate (EGCG)—a flavonoid found in green tea—inhibits the hepatitis C virus (HCV) from entering liver cells. Study findings available in the December issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, suggest that EGCG may offer an antiviral strategy to prevent HCV reinfection following liver transplantation.
HCV infection can lead to chronic hepatitis, cirrhosis, and hepatocellular carcinoma (HCC) or primary liver cancer. HCV is one of the most common causes of chronic liver disease and a primary indication for liver transplantation, affecting up to 170 million individuals worldwide according to estimates from the World Health Organization (WHO). Prior studies report that nearly 2% of the world population is infected with chronic HCV and up to 20% of the population in some countries.
While standard treatment with interferon with ribavirin and newer protease inhibitors may clear infection in some individuals, a substantial number of patients still may not respond to these therapies. For individuals receiving liver transplants due to complications from HCV, reinfection of the healthy donor liver remains a significant concern. Antiviral strategies that target HCV in its early stages are urgently needed to prevent graft reinfection and improve long-term outcomes for patients.
To address this critical issue, Dr. Sandra Ciesek and Dr. Eike Steinmann from the Hannover Medical School in Germany investigated the effect of the EGCG molecule, which is a major component of green tea, in preventing HCV from attaching to liver cells. "Green tea catechins such as EGCG and its derivatives epigallocatechin (EGC), epicatechingallate (ECG), and epicatechin (EC) have been shown to exhibit antiviral and anti-oncogenic properties," explains Dr. Ciesek. "Our study further explores the potential effect these flavonoids have in preventing HCV reinfection following liver transplantation."
Results showed that unlike its derivatives, EGCG inhibits entry of HCV into liver cells. The authors suggest that EGCG may impede HCV cell entry by acting on the host cell as the green tea catechin was not found to alter the density of virus particles. Pretreatment of cells with EGCG before HCV inoculation did not reduce the infection; however application during inoculation inhibited the rapid spread of the HCV. Lastly, researchers showed that EGCG inhibits viral attachment—the initial step in the HCV infection process. "The green tea antioxidant EGCG inhibits HCV cell entry by blocking viral attachment and may offer a new approach to prevent HCV infection, particularly reinfection following liver transplantation." concludes Dr. Ciesek.
###
Full Citation: The Green Tea Polyphenol Epigallocatechin-3-Gallate (EGCG) Inhibits Hepatitis C Virus (HCV) Entry." Sandra Ciesek, Thomas von Hahn, Che C. Colpitts, Luis M Schang,Martina Friesland, Jörg Steinmann, Michael P. Manns, Michael Ott, Heiner Wedemeyer, Philip Meuleman, Thomas Pietschmann and Eike Steinmann. Hepatology; Published Online: November 30, 2011 (DOI: 10.1002/hep.24610); Print Issue Date: December 2011. http://onlinelibrary.wiley.com/doi/10.1002/hep.24610/abstract.
Author Contact: To arrange an interview with Dr. Sandra Ciesek or Dr. Eike Steinmann, please contact Jo Schilling at jo.schilling@twincore.de.
This study is published in Hepatology. Media wishing to receive a PDF of the article may contact healthnews@wiley.com.
About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Hepatology's current impact factor is 10.885.Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350 .
About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.
The Motley Fool's Sean Williams on Inhibitex....
Inhibitex Shares Popped: What You Need to Know
By Sean Williams
December 1, 2011
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Inhibitex, one of many biotechnology companies involved in hepatitis C research, jumped as much as 13% earlier in the trading session before giving up almost all of its gains.
So what: Ever since Gilead Sciences agreed to purchase Pharmasset last week at a hefty premium, the sector has been abuzz with more buyout speculation. Optimists got more fuel for the fire earlier in the week when Inhibitex reported positive phase 2 results for INX-189, its experimental hepatitis C drug. Today's move appears to be a carryover effect of the bullishness from previous days.
Now what: To say that I'm not a fan of Inhibitex at its current valuation north of $1.1 billion might be an understatement. The company is going to face an onslaught of competition from Gilead and Pharmasset, but also from hep C drugs that are already approved by the FDA for sale, including Merck's Victrelis and Vertex Pharmaceuticals' Incivek. Then there's the fact that Inihibtex has already sold 1.9 million shares of stock into this unbelievable rally. With its leading drug candidate only in phase 2 clinical trials, there are plenty of moves left to be played in this chess game before I'd declare Inhibitex a winner. I'm so confident Inhibitex is overvalued at these levels I'm willing to bet my CAPS points on it!
By Sean Williams
December 1, 2011
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of Inhibitex, one of many biotechnology companies involved in hepatitis C research, jumped as much as 13% earlier in the trading session before giving up almost all of its gains.
So what: Ever since Gilead Sciences agreed to purchase Pharmasset last week at a hefty premium, the sector has been abuzz with more buyout speculation. Optimists got more fuel for the fire earlier in the week when Inhibitex reported positive phase 2 results for INX-189, its experimental hepatitis C drug. Today's move appears to be a carryover effect of the bullishness from previous days.
Now what: To say that I'm not a fan of Inhibitex at its current valuation north of $1.1 billion might be an understatement. The company is going to face an onslaught of competition from Gilead and Pharmasset, but also from hep C drugs that are already approved by the FDA for sale, including Merck's Victrelis and Vertex Pharmaceuticals' Incivek. Then there's the fact that Inihibtex has already sold 1.9 million shares of stock into this unbelievable rally. With its leading drug candidate only in phase 2 clinical trials, there are plenty of moves left to be played in this chess game before I'd declare Inhibitex a winner. I'm so confident Inhibitex is overvalued at these levels I'm willing to bet my CAPS points on it!
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