I don't know why, but I love reading what analysts are thinking. The touchstone is always 'hyperbole', either bear or bullish. Unfortunately, investment-related articles like this may impair what would be otherwise logical, pragmatic thinking by HCV patients and treatment providers. Orelli happens to be right about an upcoming new wave of warehousing patients for more effective...and hopefully more tolerable...medications to treat Hepatitis C, and for all the wrong reasons. Don't succumb to hype. Outside of a patient being contraindicated for treatment or some other serious life issue, there's no reason to wait 2 1/2 - 3 years for new treatments that might/might not actually make it to market. The HCV drug development landscape is polluted with once-promising drugs that never made it out of Phase II trials. What we know about HCV is that the progression of disease can be slow, but it's also non-linear. Because a patient with HCV has a fibrosis score of '0' today, doesn't mean the patient won't advance to a '3' by 2014. We also know that the more advanced the disease, the less effective the medications are likely to be. The best bet is to get treated, and the earlier the better
The Biggest Fear for Hep C Investors
By Brian Orelli
November 28, 2011
There's no doubt about it -- the hepatitis C market is huge. There are 3.2 million people in the U.S. alone infected with the virus, according to the Centers for Disease Control and Prevention.
But one of the reasons for the large number of patients could be the downfall for hepatitis C drugmakers.
Hepatitis C is a chronic disease that's slow to progress. It eventually causes liver problems including scarring of the liver or liver cancer, but that's often years after the initial infection. In fact, many of those 3.2 million Americans don't even know they're infected.
The slow progression of the disease allowed doctors to put off treatment, called warehousing, and wait for Merck's Victrelis and Vertex Pharmaceuticals' Incivek to work their way through the drug-development process. The previous generation of treatment options -- Merck's PegIntron and Roche's Pegasys -- cure only around half of the patients and had nasty side effects that weren't all that appealing, considering the flip-of-a-coin chance at a cure.
Warehousing 2.0
Clearly, many doctors and their patients have decided that they've waited enough. Incivek is off to a blustering start, registering $420 million in sales during its first full quarter on the market.
But Incivek isn't perfect. It still requires patients to take PegIntron or Pegasys, albeit for a shorter duration of time than it was used when the drugs were taken on their own. Multiple companies are going after an interferon-free regimen that would be taken orally.
Pharmasset, which is being bought by Gilead Sciences, has a hepatitis C drug candidate, PSI-7977, which looks good so far as an interferon-free treatment. Gilead has other hepatitis C drug candidates it's developing that could be used in combination with PSI-7977 if it doesn't work on its own. And there are plenty of other drugmakers, including Achillion (Nasdaq: ACHN ) , Inhibitex (Nasdaq: INHX ) , Vertex, Merck, Johnson & Johnson, and Bristol-Myers Squibb (NYSE: BMY ) , developing other hepatitis C drugs that they hope can be part of an interferon-free cocktail.
It seems entirely possible that doctors will continue warehousing all but the most-progressed patients until there's an interferon-free treatment regimen that works as well as or better than the current standard of care. If that occurs, the peak sales of Incivek would be substantially diminished.
And then ...
If patients are going to wait for all-oral interferon-free regimens, why not wait until the drugs become generic and save some money? Granted, it'll take a while to get to that stage; patients being seen by doctors right now aren't likely to be thinking that way, but it seems entirely possible that the effective patent life of hepatitis C drugs could be cut short by a few years as patients considering treatment within a few years of patent expiration might just elect to wait.
And of course, at some point, the hepatitis C market will begin to shrink. Unlike HIV drugs that aren't really a cure, hepatitis C drugs rid the patients of the virus, so as more patients are cured, the number of newly infected individuals should drop. How far in the future the drop begins will be dictated by how quickly patients get on medication, so the faster the ramp-up in sales, the sooner sales will drop off.
Far enough in the future?
That's what every hepatitis C investor has to ask: Can you capture the value now and get out before things eventually blow up?
At this point, investors seem to be ignoring the future -- Pharmasset is up more than 500% over the last year -- but that seems a little risky for long-term investors. If you're going to invest in the space for any reasonable length of time, consider a company that has its hand in more than one market. Vertex, for instance, is developing drugs for cystic fibrosis, and it's on sale.
Wednesday, November 30, 2011
Tuesday, November 29, 2011
OraSure HCV test gets FDA nod for promotional expansion...
OraSure's HCV test gets a boost thanks to an FDA nod to expand the promotion and use of the test, which will be co-marketed by Merck. The test is said to be able to determine HCV positivity within 20 minutes. The approval should also be a boon to both Merck, Vertex and near-term HCV DAA developers as this is an opportunity to expand the pool of treatable patients
OraSure gets wider use for hep C test, shares up
* Test can check for hepatitis C virus in 20 minutes
* OraSure shares up 8.8 percent
Nov 29 (Reuters) - OraSure Technologies received approval to sell its test for the hepatitis C virus to a wider range of clinics and doctors' offices in the United States, sending shares of the company up nearly 9 percent.
The company said on Tuesday the Food and Drug Administration expanded approval for the OraQuick HCV test, allowing more than 180,000 facilities to use it for detecting the serious liver disease in patients.
The FDA approved the test in February, but initially limited its use to clinically trained staff.
The test for the virus can be done via blood samples taken from a vein, or with a finger-stick test, which draws a tiny amount of blood by pricking the finger.
OraSure, based in Bethlehem, Pennsylvania, said patients can get a diagnosis in 20 minutes.
About 4 million people in the United States, and 180 million worldwide, are infected with the hepatitis C virus, the company said. Untreated, hepatitis C can lead to chronic liver disease, liver cancer and the need for a liver transplant.
Infections with the hepatitis C virus are not generally obvious. In most cases there may be no symptoms for years while the hepatitis quietly damages the liver until it is finally diagnosed.
"New therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic," Dr. Willis Maddrey, president of the Chronic Liver Disease Foundation said in a statement provided by OraSure.
Vertex Pharmaceuticals and Merck & Co both received approval to market new hepatitis C drugs earlier this year. The market for such drugs is estimated to be worth about $15 billion by 2019, and both companies are conducting campaigns to raise awareness of the disease.
An increase in hepatitis C testing should help boost sales of the new medicines.
Merck will help promote the OraQuick HCV test in doctors' offices as part of a collaboration agreement, OraSure said.
OraSure shares closed up 69 cents, or 8.8 percent, to $8.55 on Nasdaq.
OraSure gets wider use for hep C test, shares up
* Test can check for hepatitis C virus in 20 minutes
* OraSure shares up 8.8 percent
Nov 29 (Reuters) - OraSure Technologies received approval to sell its test for the hepatitis C virus to a wider range of clinics and doctors' offices in the United States, sending shares of the company up nearly 9 percent.
The company said on Tuesday the Food and Drug Administration expanded approval for the OraQuick HCV test, allowing more than 180,000 facilities to use it for detecting the serious liver disease in patients.
The FDA approved the test in February, but initially limited its use to clinically trained staff.
The test for the virus can be done via blood samples taken from a vein, or with a finger-stick test, which draws a tiny amount of blood by pricking the finger.
OraSure, based in Bethlehem, Pennsylvania, said patients can get a diagnosis in 20 minutes.
About 4 million people in the United States, and 180 million worldwide, are infected with the hepatitis C virus, the company said. Untreated, hepatitis C can lead to chronic liver disease, liver cancer and the need for a liver transplant.
Infections with the hepatitis C virus are not generally obvious. In most cases there may be no symptoms for years while the hepatitis quietly damages the liver until it is finally diagnosed.
"New therapies are now available that can effectively treat a high percentage of people with HCV infection, making expanded and accessible testing for HCV a critical step in fighting this epidemic," Dr. Willis Maddrey, president of the Chronic Liver Disease Foundation said in a statement provided by OraSure.
Vertex Pharmaceuticals and Merck & Co both received approval to market new hepatitis C drugs earlier this year. The market for such drugs is estimated to be worth about $15 billion by 2019, and both companies are conducting campaigns to raise awareness of the disease.
An increase in hepatitis C testing should help boost sales of the new medicines.
Merck will help promote the OraQuick HCV test in doctors' offices as part of a collaboration agreement, OraSure said.
OraSure shares closed up 69 cents, or 8.8 percent, to $8.55 on Nasdaq.
Monday, November 28, 2011
Seeking Alpha.com's Chris Katje on Gilead potential for antiviral dominance...
A bullish outlook for Gilead from Seeking Alpha author Chris Katje. His view is that Gilead will have market dominance in both HIV and HCV. He sees that Gilead will have full control of the Pharmasset HCV portfolio through the buyout, thus negating any worry about royalty payments. I'd also add the potential for co-formulation between Pharmasset's portfolio and Gilead's current HCV portfolio, which has always been Gilead's hallmark. An interesting read and it seems the rest of the market seems to agree with Katje, as Gilead stock has received several outlook upgrades from analysts. It just took some time for the initial sticker shock to wear off.
Acquisition of Pharmasset
Gilead Sciences (GILD) announced its intent to acquire Pharmasset (VRUS) for a whopping $11 billion on Monday morning. The deal has led many analysts and investors to question if Gilead overpaid for the deal. I think the deal is a great long-term play for the company and actually could present a buying opportunity of shares, which were down sharply after the announcement. Shares were up around five percent the following day after the announcement. Gilead will now be a large player in the HIV and Hepatitis markets.
Pharmasset has no drugs on the market, which is the biggest reason why people question the valuation. Drug candidate PSI-7977 appears to show enough promise that other companies were nibbling at acquiring the company. Gilead is confident in its acquisition and is funding the deal through cash and $6 billion in debt it is taking on. Hepatitis C is being targeted by this drug and it could actually save many Americans from the life threatening liver damage that is usually caused by the disease and leads to many liver transplants. The drug is expected to be filed with the Food and Drug Administration in 2014. Pharmasset owned the worldwide rights to the drug so Gilead will take full control and will not have to worry about licensing or royalty payments. Gilead now will be the leader in the race to find an all oral drug for the treatment of Hepatitis C.
Why the Acquisition and Hefty Premium
Gilead presented a slide show on its website shortly after the announcement to acquire Pharmasset. Gilead reconfirmed its goal of creating the best Hepatitis C drug, which would be determined by some of the following:
Taken Once Daily
Manageable Side Effects
Higher Cure Rates Than Current Drugs on the Market
Increased Treatments With a New Drug
Gilead has recognized that a combination of two or more drugs may be needed to create this super Hepatitis C drug. This is where I believe that Gilead’s acquisition will ultimately pay off. Gilead has combined several of its own drugs with products of other companies to create better acting and more effective drugs for patients.
Competition in Hepatitis C Market
Several other Hepatitis C drugs have popped up on the market recently. Victrelis is a drug owned by Merck (MRK), acquired through its acquisition of Schering Plough. The drug has so far been a disappointment as it only brought in $31 million of revenue in the third quarter reported on October 31, for Merck. Incivek, a drug owned by Vertex Pharmaceuticals (VRTX), on the other hand posted sales of $419 million in the past quarter. Analysts have already been lowering price targets of VRTX because of the likely competition from PS-7977 pending approval. Vertex will enjoy a couple of years of dominating market share before the competing drug enters the market. Annual sales could hit $2 to $3 billion for Vertex. Merck on the other hand is playing second fiddle and is likely to never see blockbuster status with its Hepatitis C drug.
Gilead’s Biggest Acquisitions
Gilead has a long history of acquiring other drug companies as many large drug companies do. Highlights include:
1999 Nexstar Pharmaceuticals - Gained two drugs through the acquisition. One, Ambisome, is still a marketed drug by Gilead. Deal seemed to be made more for the company’s intent on expanding in Europe.
2003 Triangle Pharmaceuticals - Emtriva, now a part of two Gilead drugs, was gained through this $464 million acquisition. Atripla and Truvada both use the component emtricitabine, a former Triangle product.
2006 Corrus Pharma - Has a current drug in Gilead’s pipeline aimed at treating Cystic Fibrosis.
2006 Myogen - Myogen was the most expensive acquisition previous to Pharmasset coming in at $2.5 billion. This has also been one of the most important and successful acquisitions made by Gilead as it brought three drugs, two marketed, and one currently sold by Gilead to the company.
2009 CV Therapeutics - Billion dollar purchase helped strengthen and diversify Gilead’s pool of drugs as it gained two drugs aimed at cardiovascular diseases.
Several other million dollar deals were made by Gilead over the last eight years. Gilead has made many of its acquisitions to strengthen its own technology and combine existing drugs with new ones.
Gilead’s Products
Gilead remains the market leader in drugs that treat the HIV virus. Its marketed products in the HIV market are:
Atripla is marketed with Bristol Myers Squibb (BMY) after its approval in 2006. The drug treats HIV and will lose patent expiration in 2021.
Complera is one of Gilead’s newest drugs on the market. It was approved by the FDA in August of 2011, and is co-marketed with Johnson and Johnson (JNJ).
Emtriva was approved in 2003 and will expire in 2021.
Truvada treats HIV and is one of Gilead’s top selling drugs. It was approved in 2004 and will lose its patent protection in 2021.
Viread treats Hepatitis B and HIV viruses. The drug was the first successfully launched HIV drug in 2001 by Gilead. The drug, which is a huge seller for Gilead, will lose patent protection in 2017.
Gilead has drugs in several other fields that compete with numerous other large drug companies. The other drugs currently on the market are:
Ambisome treats infections like fungal, meningitis, and Cryptococcus. The drug was approved in 1997 and will lose patent protection in 2016. The marketing partner on the drug is Astellas Pharma.
Cayston is Gilead’s cystic fibrosis drug that was approved in 2010. The drug has exclusive patent protection until 2021. Gilead markets the drug on its own and maintains all revenue from the drug.
Hepsera treats Hepatitis B and is owned and marketed by Gilead. The drug was approved in 2002 and its patent expires in 2014.
Letairis has since 2007 treated Pulmonary Hypertension. The drug is co-marketed with GlasxoSmithKline (GSK) and loses patent protection in 2015.
Lexiscan is a cardiovascular drug marketed with Astellas Pharma and it will lose patent protection in 2019.
Macugen is an age-related macular degeneration drug first approved in 2004, which is shared with Pfizer (PFE) and will lose patent protection in 2017.
Ranexa treats chest pain and will lose patent protection in 2019. The drug is co-marketed with Swiss drug company Roche.
Tamiflu treats the influenza virus as an oral capsule. The drug, which loses its patent protection in 2016, is licensed to Roche.
Vistide treats Cytomegalovirus and also certain eye problems involving the retina. The drug was founded in 1996 and has since lost its patent protection.
Gilead’s Pipeline
Gilead has twenty drugs listed on its site in current phases of trial. The drugs target HIV, Hepatitis C, numerous Cardiovascular diseases, Diabetes, Leukemia, Non-Hodgkin’s Lymphoma, and other diseases. Like many other large drug companies, Gilead has kept a strong pipeline targeting some of the biggest diseases affecting the world today. Three drugs targeting HIV are in Phase III trials currently. The Pharmasset acquisition will improve the company’s pipeline as it focuses on becoming a large player in the Hepatitis C market. Gilead will likely test several of its own Hepatitis drugs with Pharmasset products to create dual drugs much like it has with its HIV drugs.
The most important drug for Gilead in my opinion is known as the Quad. The drug combines Gilead’s own products and will help cut part of its revenue share with other marketing partners. The drug has held up well in trials. The drug will be brought in front of the FDA in 2012 and could be a substantial revenue earner for Gilead. The Quad drug is cutting down on symptoms from Gilead’s Atripla including dizziness, insomnia and depression. There are two trials testing Gilead drugs together in the Quad trials. Atripla had sales of $2.9 billion over the last year. However a portion of that revenue is given to Bristol Myers Squibb for its contribution to the drug. The approval of the quad pill could provide a nice bump to the share price in 2012.
Gilead’s Current Sales
Gilead is the leader in the HIV drug market and has shown its dominance. From the slide show presentation after the Pharmasset announcement it listed trailing twelve month revenue at $7.4 billion. The total market for HIV drugs is currently $13 billion so Gilead controls 50% of this blockbuster medical category. In the last fiscal year Gilead had earnings per share of $3.32 based on earnings of $2.9 billion.
Analysts call for earnings of $4.37 for the next fiscal year. With a closing share price of $39.28 on Friday, the price-to-earnings ratio is less than nine. According to Yahoo Finance, over 91% of the shares are currently held by institutions and mutual funds. More than 900 funds hold shares of Gilead as it represents one of the best plays on the healthcare and drugs industry.
Analyst Upgrades
Several days after the acquisition of Pharmasset was announced, analysts have upgraded shares. Citigroup and Bank of America both upgraded the shares after revaluating. Bank of America said that the company’s Hepatitis C program could some day be worth $15 to $30 billion. Gilead currently has a market capitalization of just under $30 billion so this deal could clearly define the company for the future.
My Share Valuation
I think the buyout of Pharmasset is a great purchase for Gilead. Gilead has made great use of drugs acquired through pipelines of companies it has bought out. Gilead absolutely owns the HIV drug market and the deal should help insure it gets a large portion of the Hepatitis C drug market in the future as well. For the coming year shares should trade closer to 12 times earnings, which would represent a share price of $52.44. The approval of the Quad drug as well as earnings announcements could power shares past $60. I think long term the company could double its market capitalization to $60 billion with its marketed HIV drugs and several Hepatitis C drugs on the market. I think shares would be a great purchase for an IRA as a bet on the company for the future.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in GILD over the next 72 hours.
Acquisition of Pharmasset
Gilead Sciences (GILD) announced its intent to acquire Pharmasset (VRUS) for a whopping $11 billion on Monday morning. The deal has led many analysts and investors to question if Gilead overpaid for the deal. I think the deal is a great long-term play for the company and actually could present a buying opportunity of shares, which were down sharply after the announcement. Shares were up around five percent the following day after the announcement. Gilead will now be a large player in the HIV and Hepatitis markets.
Pharmasset has no drugs on the market, which is the biggest reason why people question the valuation. Drug candidate PSI-7977 appears to show enough promise that other companies were nibbling at acquiring the company. Gilead is confident in its acquisition and is funding the deal through cash and $6 billion in debt it is taking on. Hepatitis C is being targeted by this drug and it could actually save many Americans from the life threatening liver damage that is usually caused by the disease and leads to many liver transplants. The drug is expected to be filed with the Food and Drug Administration in 2014. Pharmasset owned the worldwide rights to the drug so Gilead will take full control and will not have to worry about licensing or royalty payments. Gilead now will be the leader in the race to find an all oral drug for the treatment of Hepatitis C.
Why the Acquisition and Hefty Premium
Gilead presented a slide show on its website shortly after the announcement to acquire Pharmasset. Gilead reconfirmed its goal of creating the best Hepatitis C drug, which would be determined by some of the following:
Taken Once Daily
Manageable Side Effects
Higher Cure Rates Than Current Drugs on the Market
Increased Treatments With a New Drug
Gilead has recognized that a combination of two or more drugs may be needed to create this super Hepatitis C drug. This is where I believe that Gilead’s acquisition will ultimately pay off. Gilead has combined several of its own drugs with products of other companies to create better acting and more effective drugs for patients.
Competition in Hepatitis C Market
Several other Hepatitis C drugs have popped up on the market recently. Victrelis is a drug owned by Merck (MRK), acquired through its acquisition of Schering Plough. The drug has so far been a disappointment as it only brought in $31 million of revenue in the third quarter reported on October 31, for Merck. Incivek, a drug owned by Vertex Pharmaceuticals (VRTX), on the other hand posted sales of $419 million in the past quarter. Analysts have already been lowering price targets of VRTX because of the likely competition from PS-7977 pending approval. Vertex will enjoy a couple of years of dominating market share before the competing drug enters the market. Annual sales could hit $2 to $3 billion for Vertex. Merck on the other hand is playing second fiddle and is likely to never see blockbuster status with its Hepatitis C drug.
Gilead’s Biggest Acquisitions
Gilead has a long history of acquiring other drug companies as many large drug companies do. Highlights include:
1999 Nexstar Pharmaceuticals - Gained two drugs through the acquisition. One, Ambisome, is still a marketed drug by Gilead. Deal seemed to be made more for the company’s intent on expanding in Europe.
2003 Triangle Pharmaceuticals - Emtriva, now a part of two Gilead drugs, was gained through this $464 million acquisition. Atripla and Truvada both use the component emtricitabine, a former Triangle product.
2006 Corrus Pharma - Has a current drug in Gilead’s pipeline aimed at treating Cystic Fibrosis.
2006 Myogen - Myogen was the most expensive acquisition previous to Pharmasset coming in at $2.5 billion. This has also been one of the most important and successful acquisitions made by Gilead as it brought three drugs, two marketed, and one currently sold by Gilead to the company.
2009 CV Therapeutics - Billion dollar purchase helped strengthen and diversify Gilead’s pool of drugs as it gained two drugs aimed at cardiovascular diseases.
Several other million dollar deals were made by Gilead over the last eight years. Gilead has made many of its acquisitions to strengthen its own technology and combine existing drugs with new ones.
Gilead’s Products
Gilead remains the market leader in drugs that treat the HIV virus. Its marketed products in the HIV market are:
Atripla is marketed with Bristol Myers Squibb (BMY) after its approval in 2006. The drug treats HIV and will lose patent expiration in 2021.
Complera is one of Gilead’s newest drugs on the market. It was approved by the FDA in August of 2011, and is co-marketed with Johnson and Johnson (JNJ).
Emtriva was approved in 2003 and will expire in 2021.
Truvada treats HIV and is one of Gilead’s top selling drugs. It was approved in 2004 and will lose its patent protection in 2021.
Viread treats Hepatitis B and HIV viruses. The drug was the first successfully launched HIV drug in 2001 by Gilead. The drug, which is a huge seller for Gilead, will lose patent protection in 2017.
Gilead has drugs in several other fields that compete with numerous other large drug companies. The other drugs currently on the market are:
Ambisome treats infections like fungal, meningitis, and Cryptococcus. The drug was approved in 1997 and will lose patent protection in 2016. The marketing partner on the drug is Astellas Pharma.
Cayston is Gilead’s cystic fibrosis drug that was approved in 2010. The drug has exclusive patent protection until 2021. Gilead markets the drug on its own and maintains all revenue from the drug.
Hepsera treats Hepatitis B and is owned and marketed by Gilead. The drug was approved in 2002 and its patent expires in 2014.
Letairis has since 2007 treated Pulmonary Hypertension. The drug is co-marketed with GlasxoSmithKline (GSK) and loses patent protection in 2015.
Lexiscan is a cardiovascular drug marketed with Astellas Pharma and it will lose patent protection in 2019.
Macugen is an age-related macular degeneration drug first approved in 2004, which is shared with Pfizer (PFE) and will lose patent protection in 2017.
Ranexa treats chest pain and will lose patent protection in 2019. The drug is co-marketed with Swiss drug company Roche.
Tamiflu treats the influenza virus as an oral capsule. The drug, which loses its patent protection in 2016, is licensed to Roche.
Vistide treats Cytomegalovirus and also certain eye problems involving the retina. The drug was founded in 1996 and has since lost its patent protection.
Gilead’s Pipeline
Gilead has twenty drugs listed on its site in current phases of trial. The drugs target HIV, Hepatitis C, numerous Cardiovascular diseases, Diabetes, Leukemia, Non-Hodgkin’s Lymphoma, and other diseases. Like many other large drug companies, Gilead has kept a strong pipeline targeting some of the biggest diseases affecting the world today. Three drugs targeting HIV are in Phase III trials currently. The Pharmasset acquisition will improve the company’s pipeline as it focuses on becoming a large player in the Hepatitis C market. Gilead will likely test several of its own Hepatitis drugs with Pharmasset products to create dual drugs much like it has with its HIV drugs.
The most important drug for Gilead in my opinion is known as the Quad. The drug combines Gilead’s own products and will help cut part of its revenue share with other marketing partners. The drug has held up well in trials. The drug will be brought in front of the FDA in 2012 and could be a substantial revenue earner for Gilead. The Quad drug is cutting down on symptoms from Gilead’s Atripla including dizziness, insomnia and depression. There are two trials testing Gilead drugs together in the Quad trials. Atripla had sales of $2.9 billion over the last year. However a portion of that revenue is given to Bristol Myers Squibb for its contribution to the drug. The approval of the quad pill could provide a nice bump to the share price in 2012.
Gilead’s Current Sales
Gilead is the leader in the HIV drug market and has shown its dominance. From the slide show presentation after the Pharmasset announcement it listed trailing twelve month revenue at $7.4 billion. The total market for HIV drugs is currently $13 billion so Gilead controls 50% of this blockbuster medical category. In the last fiscal year Gilead had earnings per share of $3.32 based on earnings of $2.9 billion.
Analysts call for earnings of $4.37 for the next fiscal year. With a closing share price of $39.28 on Friday, the price-to-earnings ratio is less than nine. According to Yahoo Finance, over 91% of the shares are currently held by institutions and mutual funds. More than 900 funds hold shares of Gilead as it represents one of the best plays on the healthcare and drugs industry.
Analyst Upgrades
Several days after the acquisition of Pharmasset was announced, analysts have upgraded shares. Citigroup and Bank of America both upgraded the shares after revaluating. Bank of America said that the company’s Hepatitis C program could some day be worth $15 to $30 billion. Gilead currently has a market capitalization of just under $30 billion so this deal could clearly define the company for the future.
My Share Valuation
I think the buyout of Pharmasset is a great purchase for Gilead. Gilead has made great use of drugs acquired through pipelines of companies it has bought out. Gilead absolutely owns the HIV drug market and the deal should help insure it gets a large portion of the Hepatitis C drug market in the future as well. For the coming year shares should trade closer to 12 times earnings, which would represent a share price of $52.44. The approval of the Quad drug as well as earnings announcements could power shares past $60. I think long term the company could double its market capitalization to $60 billion with its marketed HIV drugs and several Hepatitis C drugs on the market. I think shares would be a great purchase for an IRA as a bet on the company for the future.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in GILD over the next 72 hours.
Hep C Protease Inhibitors May Not Be Cost-Effective For Some First-Time Treatment Takers
From http://www.hepmag.com, a synopsis of an AASLD study authored byZiad Gellad, MD, MPH, of Duke University Medical Center that argues triple therapy may not be the most cost-effective stragtegy for genotype 1 patients with the IL-28B CC genotype. As we know, patients with the CC genotype are more likely to respond to peg-interferon and ribavirin alone, at a significant cost savings compared to starting these patients on a HCV protease inhibitor. According to Gellad, " for first-time treatment takers with the IL-28B CC genotype, adding Incivek “is unlikely to be cost-effective under current cost and efficacy conditions”
Hepatitis C virus (HCV) protease inhibitors are not cost-effective for first-time treatment takers with HCV genotype 1 and the IL-28B CC genotype, according to analysis conducted by Ziad Gellad, MD, MPH, of Duke University Medical Center in Durham, North Carolina, and his colleagues. They reported their findings on Monday, November 7, at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. According to the study authors, people with the IL-28B CC genotype are more likely to be cured with pegylated interferon and ribavirin alone than people with the IL-28B CT or TT genotypes, for whom the addition of either Incivek (telaprevir) or Victrelis (boceprevir) may be more cost effective.
A 24- to 48-week course of pegylated interferon and ribavirin ranges from $18,000 to $30,000. As Gellad noted, “adding Incivek (telaprevir) or Victrelis (boceprevir)”—both recently approved HCV protease inhibitors—“more than doubles the cost of therapy, to a range of $48,000 to $85,000.”
An advantage of Incivek and Victrelis is that they can improve the effectiveness of treatment when added to a combination of pegylated interferon and ribavirin. This is particularly true for people with the IL-28B CT or TT genotype, which is believed to reduce the effectiveness of pegylated interferon, which remains a backbone of hepatitis C treatment. Conversely, those with the IL-28B CC genotype are much more likely to respond effectively to pegylated interferon-ribavirin therapy. Thus, it remains unclear if adding either Incivek or Victrelis to pegylated interferon/ribavirin—provided that the patient has an IL-28B CC genotype and is starting therapy for the first time—translates into added effectiveness worth the additional cost of either drug.
The authors created a model that allowed them to analyze three HCV treatment strategies. The first strategy involved 48 weeks of treatment with pegylated interferon plus ribavirin. The second strategy involved 24 weeks of pegylated interferon and ribavirin according to response-guided therapy (RGT) rules, which take into consideration viral load measurements at weeks four and 12 of treatment. The third strategy involved 12 weeks of Incivek in combination with either 24 or 38 weeks of pegylated interferon plus ribavirin.
According to the analysis by Gellad’s team, the cure rates among first-time treatment takers with the CC genotype were similar, yet the costs of each regimen varied considerable. Among those who qualified for 24 weeks of RGT with pegylated interferon and ribavirin alone, the cure rate was expected to be roughly 71 percent at a cost of $46,785. The cost increased to $54,931 when interferon/ribavirin was used for a total of 48 weeks, with an expected cure rate of 66 percent. If retreatment was necessary in either circumstance, roughly 87 percent to 91 percent would be cured.
Starting hepatitis C treatment with an Incivek-inclusive regimen was expected to cure 89 percent of HCV-positive individuals with the CC IL-28B genotype—at a cost of $68,788. According to estimates of lifetime treatment costs and quality-adjusted life-years (QALYs) measurements, however, the gain did not differ significantly compared with the other two strategies.
Adding Incivek to pegylated interferon and ribavirin was cost-effective for first-time treatment takers in certain circumstances, Gellad and his colleagues noted, such as when it enhanced the early response to hepatitis C treatment (known as extended rapid virologic response, or eRVR). An eRVR—when hepatitis C viral load is undetectable at treatment week 4 and remains that way at week 12—is a strong predictor of being cured. Incivek was considered cost-effective when it boosted the eRVR rate to 89 percent. For people who did not have an eRVR, Incivek was cost effective if it could increase cure rates to over 80 percent. In addition, the authors considered Incivek to be cost-effective for retreating people who relapsed or did not respond to dual therapy.
In summary, for first-time treatment takers with the IL-28B CC genotype, adding Incivek “is unlikely to be cost-effective under current cost and efficacy conditions,” said Gellad, who concluded by recommending research to compare effectiveness of treatment with and without an HCV protease inhibitor in this group.
Hepatitis C virus (HCV) protease inhibitors are not cost-effective for first-time treatment takers with HCV genotype 1 and the IL-28B CC genotype, according to analysis conducted by Ziad Gellad, MD, MPH, of Duke University Medical Center in Durham, North Carolina, and his colleagues. They reported their findings on Monday, November 7, at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco. According to the study authors, people with the IL-28B CC genotype are more likely to be cured with pegylated interferon and ribavirin alone than people with the IL-28B CT or TT genotypes, for whom the addition of either Incivek (telaprevir) or Victrelis (boceprevir) may be more cost effective.
A 24- to 48-week course of pegylated interferon and ribavirin ranges from $18,000 to $30,000. As Gellad noted, “adding Incivek (telaprevir) or Victrelis (boceprevir)”—both recently approved HCV protease inhibitors—“more than doubles the cost of therapy, to a range of $48,000 to $85,000.”
An advantage of Incivek and Victrelis is that they can improve the effectiveness of treatment when added to a combination of pegylated interferon and ribavirin. This is particularly true for people with the IL-28B CT or TT genotype, which is believed to reduce the effectiveness of pegylated interferon, which remains a backbone of hepatitis C treatment. Conversely, those with the IL-28B CC genotype are much more likely to respond effectively to pegylated interferon-ribavirin therapy. Thus, it remains unclear if adding either Incivek or Victrelis to pegylated interferon/ribavirin—provided that the patient has an IL-28B CC genotype and is starting therapy for the first time—translates into added effectiveness worth the additional cost of either drug.
The authors created a model that allowed them to analyze three HCV treatment strategies. The first strategy involved 48 weeks of treatment with pegylated interferon plus ribavirin. The second strategy involved 24 weeks of pegylated interferon and ribavirin according to response-guided therapy (RGT) rules, which take into consideration viral load measurements at weeks four and 12 of treatment. The third strategy involved 12 weeks of Incivek in combination with either 24 or 38 weeks of pegylated interferon plus ribavirin.
According to the analysis by Gellad’s team, the cure rates among first-time treatment takers with the CC genotype were similar, yet the costs of each regimen varied considerable. Among those who qualified for 24 weeks of RGT with pegylated interferon and ribavirin alone, the cure rate was expected to be roughly 71 percent at a cost of $46,785. The cost increased to $54,931 when interferon/ribavirin was used for a total of 48 weeks, with an expected cure rate of 66 percent. If retreatment was necessary in either circumstance, roughly 87 percent to 91 percent would be cured.
Starting hepatitis C treatment with an Incivek-inclusive regimen was expected to cure 89 percent of HCV-positive individuals with the CC IL-28B genotype—at a cost of $68,788. According to estimates of lifetime treatment costs and quality-adjusted life-years (QALYs) measurements, however, the gain did not differ significantly compared with the other two strategies.
Adding Incivek to pegylated interferon and ribavirin was cost-effective for first-time treatment takers in certain circumstances, Gellad and his colleagues noted, such as when it enhanced the early response to hepatitis C treatment (known as extended rapid virologic response, or eRVR). An eRVR—when hepatitis C viral load is undetectable at treatment week 4 and remains that way at week 12—is a strong predictor of being cured. Incivek was considered cost-effective when it boosted the eRVR rate to 89 percent. For people who did not have an eRVR, Incivek was cost effective if it could increase cure rates to over 80 percent. In addition, the authors considered Incivek to be cost-effective for retreating people who relapsed or did not respond to dual therapy.
In summary, for first-time treatment takers with the IL-28B CC genotype, adding Incivek “is unlikely to be cost-effective under current cost and efficacy conditions,” said Gellad, who concluded by recommending research to compare effectiveness of treatment with and without an HCV protease inhibitor in this group.
Tuesday, November 22, 2011
University of Liverpool launches an iPhone app for HCV DAA drug interactions...
(Finally, an app that is immediately practical! The new HEP i-Chart app launched by University of Liverpool researchers assists patients and providers alike in keeping up to date with possible drug-drug interactions between the new Direct Acting Antivirals for Hepatitis C and other medications and herbs. More info at http://www.hep-druginteractions.org/ )
The University of Liverpool has launched an iphone app, HEP i-chart, that provides Hepatitis C (HCV) patients with quick and easy access to the latest information about drug interactions.
Hepatitis C was first discovered in the 1980s when it became apparent that there was a new virus (not the already known hepatitis A or B) causing liver damage. Hepatitis C causes inflammation and swelling of the liver. It is estimated that over 170million individuals – representing 3% of the world's population – are chronically infected with the Hepatitis C virus (HCV). Statistically, as many people are infected with HCV as are with HIV.
Since its identification, drug treatment to eradicate the virus has advanced greatly, especially in the last few years. Two new drugs have recently been licensed for treatment of HCV, and there are more drugs in development.
HEP i-chart is based on the website (http://www.hep-druginteractions.org/) developed at the University by Professor David Back and Professor Saye Khoo which provides a comprehensive online guide to the interactions between anti-hepatitis drugs and other drugs. It is a tool that provides Hepatitis C patients and healthcare professionals with immediate access to up-to-date information on potential drug interactions between HCV drugs, and other drugs that the patient may be prescribed as well as over-the-counter, recreational or herbal medications.
Existing HCV drugs, newly licensed drugs and drugs in development can have interactions with each other and with other drugs which can impact on their effectiveness – sometimes with serious consequences. For this reason, some drug combinations must not be used, whilst others must be given with caution, possibly requiring adjustment or monitoring.
Professor of Pharmacology, David Back, said: "We are delighted to launch with our partners – KnowledgePoint360, MSD and Janssen- this new i-phone application that provides Hepatitis C patients and healthcare professionals with instant and easy access to information about HCV drug interactions which is relevant and reliable and up-to-date. This resource is especially important as new HCV drug treatments are approved and come into use."
Professor Graham Foster, President of the British Association for the Study of the Liver (BASL) said: "This new app, HEP i-chart, is a timely and much-needed resource for HCV patients as the number of new drugs which are available to treat Hepatitis C increases."
The University of Liverpool has launched an iphone app, HEP i-chart, that provides Hepatitis C (HCV) patients with quick and easy access to the latest information about drug interactions.
Hepatitis C was first discovered in the 1980s when it became apparent that there was a new virus (not the already known hepatitis A or B) causing liver damage. Hepatitis C causes inflammation and swelling of the liver. It is estimated that over 170million individuals – representing 3% of the world's population – are chronically infected with the Hepatitis C virus (HCV). Statistically, as many people are infected with HCV as are with HIV.
Since its identification, drug treatment to eradicate the virus has advanced greatly, especially in the last few years. Two new drugs have recently been licensed for treatment of HCV, and there are more drugs in development.
HEP i-chart is based on the website (http://www.hep-druginteractions.org/) developed at the University by Professor David Back and Professor Saye Khoo which provides a comprehensive online guide to the interactions between anti-hepatitis drugs and other drugs. It is a tool that provides Hepatitis C patients and healthcare professionals with immediate access to up-to-date information on potential drug interactions between HCV drugs, and other drugs that the patient may be prescribed as well as over-the-counter, recreational or herbal medications.
Existing HCV drugs, newly licensed drugs and drugs in development can have interactions with each other and with other drugs which can impact on their effectiveness – sometimes with serious consequences. For this reason, some drug combinations must not be used, whilst others must be given with caution, possibly requiring adjustment or monitoring.
Professor of Pharmacology, David Back, said: "We are delighted to launch with our partners – KnowledgePoint360, MSD and Janssen- this new i-phone application that provides Hepatitis C patients and healthcare professionals with instant and easy access to information about HCV drug interactions which is relevant and reliable and up-to-date. This resource is especially important as new HCV drug treatments are approved and come into use."
Professor Graham Foster, President of the British Association for the Study of the Liver (BASL) said: "This new app, HEP i-chart, is a timely and much-needed resource for HCV patients as the number of new drugs which are available to treat Hepatitis C increases."
The San Francisco Chronicle on the Gilead/Pharmasset deal...
The San Francisco Chronicle speculates that Gilead's acquisition of Pharmasset...at a premium... may start a trend of other companies vested heavily in the antiviral arena buying similar, smaller companies with potentially commercially viable molecules in development. I don't know if we'll see this large a premium paid for a company again in the near future, but the article does name Inhibitex, Achillion and Idenix Pharmaceuticals as possible takeover targets by antiviral behemoths like J&J, BMS and Roche.
Gilead's Pharmasset buy may spur similar deals
Meg Tirrell,Tara Lachapelle, Bloomberg News
Tuesday, November 22, 2011
Gilead Sciences' acquisition of Pharmasset at the highest valuation on record for a drug takeover is turning makers of hepatitis C therapies from Inhibitex to Achillion Pharmaceuticals into the next targets.
Gilead agreed Monday to buy Pharmasset for $10.8 billion, valuing the developer of an experimental, oral treatment at 70 times its net assets, the most ever for a medical drug acquisition greater than $500 million, according to data compiled by Bloomberg. The price is 94 percent higher than Pharmasset's 20-day average, also the industry's richest on record. Applying that premium, Inhibitex would cost $1.1 billion, Achillion $791 million, and Idenix Pharmaceuticals $1.3 billion, the data show.
With the market for the next generation of hepatitis C therapies potentially worth $20 billion by 2020, Inhibitex, Achillion and Idenix may be bought within a year, William Blair & Co. said. While Gilead suffered its steepest stock drop in a year and a half Monday, and none of these unprofitable biotechnology companies have a hepatitis C drug for sale yet, the other targets would require no more than a fifth of the price for Pharmasset even with the same premium, the data show.
Waves of deals
"These deals tend to happen in waves," said Dan Veru, who oversees $3.4 billion including Pharmasset shares as chief investment officer of Palisade Capital Management LLC. "It's amazing to me that Gilead's willing to gamble $11 billion. It is a statement on the future opportunity to the market. Hepatitis C is an enormous business target."
Foster City's Gilead, the world's largest maker of HIV medicines, is paying $137 a share in cash for Pharmasset to gain an oral drug in development for a virus that is now largely treated with injections. The price tag is 70 times its book value, or the value of its assets minus liabilities, topping the industry's previous record of 60 times when Barr Laboratories Inc. bought Duramed Pharmaceuticals Inc. in 2001, according to data compiled by Bloomberg.
Pharmasset reported earlier this month that 40 patients who received its experimental hepatitis C treatment, PSI-7977, were responsive after 12 weeks. About half the patients had been followed up to 24 weeks and were all cured with no significant adverse events. The drug was tested in combination with ribavirin, a medication currently used in treating the disease, in patients with hepatitis C genotypes 2 and 3. Genotype 1 is most common and hardest to treat.
Hepatitis C is a viral infection that can lead to swelling of the liver. As many as 170 million people globally carry the virus, which is transmitted through exposure to infected blood, and more than 350,000 die from related illnesses each year, according to the World Health Organization.
"Hepatitis C is very prevalent in the population," said Andrew Berens, a senior health care analyst with Bloomberg Industries. "A lot of the market opportunity is going to expand if you have an all-oral regimen. We're going to see a land grab to try and get companies that are developing them."
Shares tripled
Even after Pharmasset's shares more than tripled this year before the deal was announced, the price is still 94 percent higher than its 20-day average of $70.65. That's a record for a takeover greater than $500 million in the drug industry, which has fetched an average premium of only 25 percent, according to data compiled by Bloomberg.
"Usually we associate these kinds of premiums with biotech bull markets, but it also can be a function of other possible bidders, scarcity and stage of assets," said Les Funtleyder, a health strategist and portfolio manager at Miller Tabak & Co., which owns Pharmasset shares. "If anybody was thinking about doing something in hepatitis C, they would be thinking a lot harder today than they would be yesterday."
Pharmaceutical companies that may look to expand in the market for hepatitis C treatments include Roche Holding AG, Merck & Co., Bristol-Myers Squibb Co. and Johnson & Johnson, according to Funtleyder and Brian Skorney, an analyst at Brean Murray Carret & Co.
These companies are "all heavily invested in the antiviral arena," Skorney said. "Worldwide this is a huge, huge market opportunity."
Market data provided by Bloomberg News
Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/11/22/BUBM1M2KS9.DTL#ixzz1eV5AwfCx
Gilead's Pharmasset buy may spur similar deals
Meg Tirrell,Tara Lachapelle, Bloomberg News
Tuesday, November 22, 2011
Gilead Sciences' acquisition of Pharmasset at the highest valuation on record for a drug takeover is turning makers of hepatitis C therapies from Inhibitex to Achillion Pharmaceuticals into the next targets.
Gilead agreed Monday to buy Pharmasset for $10.8 billion, valuing the developer of an experimental, oral treatment at 70 times its net assets, the most ever for a medical drug acquisition greater than $500 million, according to data compiled by Bloomberg. The price is 94 percent higher than Pharmasset's 20-day average, also the industry's richest on record. Applying that premium, Inhibitex would cost $1.1 billion, Achillion $791 million, and Idenix Pharmaceuticals $1.3 billion, the data show.
With the market for the next generation of hepatitis C therapies potentially worth $20 billion by 2020, Inhibitex, Achillion and Idenix may be bought within a year, William Blair & Co. said. While Gilead suffered its steepest stock drop in a year and a half Monday, and none of these unprofitable biotechnology companies have a hepatitis C drug for sale yet, the other targets would require no more than a fifth of the price for Pharmasset even with the same premium, the data show.
Waves of deals
"These deals tend to happen in waves," said Dan Veru, who oversees $3.4 billion including Pharmasset shares as chief investment officer of Palisade Capital Management LLC. "It's amazing to me that Gilead's willing to gamble $11 billion. It is a statement on the future opportunity to the market. Hepatitis C is an enormous business target."
Foster City's Gilead, the world's largest maker of HIV medicines, is paying $137 a share in cash for Pharmasset to gain an oral drug in development for a virus that is now largely treated with injections. The price tag is 70 times its book value, or the value of its assets minus liabilities, topping the industry's previous record of 60 times when Barr Laboratories Inc. bought Duramed Pharmaceuticals Inc. in 2001, according to data compiled by Bloomberg.
Pharmasset reported earlier this month that 40 patients who received its experimental hepatitis C treatment, PSI-7977, were responsive after 12 weeks. About half the patients had been followed up to 24 weeks and were all cured with no significant adverse events. The drug was tested in combination with ribavirin, a medication currently used in treating the disease, in patients with hepatitis C genotypes 2 and 3. Genotype 1 is most common and hardest to treat.
Hepatitis C is a viral infection that can lead to swelling of the liver. As many as 170 million people globally carry the virus, which is transmitted through exposure to infected blood, and more than 350,000 die from related illnesses each year, according to the World Health Organization.
"Hepatitis C is very prevalent in the population," said Andrew Berens, a senior health care analyst with Bloomberg Industries. "A lot of the market opportunity is going to expand if you have an all-oral regimen. We're going to see a land grab to try and get companies that are developing them."
Shares tripled
Even after Pharmasset's shares more than tripled this year before the deal was announced, the price is still 94 percent higher than its 20-day average of $70.65. That's a record for a takeover greater than $500 million in the drug industry, which has fetched an average premium of only 25 percent, according to data compiled by Bloomberg.
"Usually we associate these kinds of premiums with biotech bull markets, but it also can be a function of other possible bidders, scarcity and stage of assets," said Les Funtleyder, a health strategist and portfolio manager at Miller Tabak & Co., which owns Pharmasset shares. "If anybody was thinking about doing something in hepatitis C, they would be thinking a lot harder today than they would be yesterday."
Pharmaceutical companies that may look to expand in the market for hepatitis C treatments include Roche Holding AG, Merck & Co., Bristol-Myers Squibb Co. and Johnson & Johnson, according to Funtleyder and Brian Skorney, an analyst at Brean Murray Carret & Co.
These companies are "all heavily invested in the antiviral arena," Skorney said. "Worldwide this is a huge, huge market opportunity."
Market data provided by Bloomberg News
Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/11/22/BUBM1M2KS9.DTL#ixzz1eV5AwfCx
Monday, November 21, 2011
Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion
This is a game-changer in HCV drug development. Gilead, long a commercial juggernaut in the HBV and HIV commercial space, purchases Pharmasset whose HCV development portfolio includes it's AASLD show-stopper nucleotide analog PSI-7977. Gilead already has an impressive HCV drug development program in place and with it's expertise in antiviral co-formulation, one can foresee leveragin that expertise to Gilead's full advantage in developing all-oral HCV antiviral compounds. It will be interesting to see how the competition reacts. It could be game-over for many otherwise fledgling development programs whose molecules just won't be able to compete
Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion
- Accelerates Development of All-Oral Regimen for the Treatment of HCV -
- Leverages Gilead's Infrastructure and Expertise in Antiviral Drug Development, Manufacturing and Commercialization -
FOSTER CITY, Calif. & PRINCETON, N.J., Nov 21, 2011 (BUSINESS WIRE) --
Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) announced today that the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash. The transaction, which values Pharmasset at approximately $11 billion, was unanimously approved by Pharmasset's Board of Directors. Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes. The company expects the transaction, when completed, to be dilutive to Gilead's earnings through 2014 and accretive in 2015 and beyond. Further guidance will be provided when the transaction closes, which is expected to be in the first quarter of 2012.
Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.
"The acquisition of Pharmasset represents an important and exciting opportunity to accelerate Gilead's effort to change the treatment paradigm for HCV-infected patients by developing all-oral regimens for the treatment of the disease regardless of viral genotype," said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead. "Pharmasset presented compelling Phase 2 data earlier this month further characterizing the strong efficacy and safety profile of PSI-7977. The compound, together with Pharmasset's other pipeline candidates, represents a strong strategic fit with Gilead's vision, pipeline and capabilities. This transaction will serve to drive the long-term growth of our business, and we look forward to working closely with the Pharmasset team to advance a broad clinical program in HCV to address the unmet needs of patients and the medical community."
"We are excited to join together with Gilead, which shares our commitment to providing HCV patients with new, highly efficacious and safe oral therapies," said Schaefer Price, President and Chief Executive Officer, Pharmasset. "We are very encouraged by the data from our Phase 2 studies of PSI-7977 and believe strongly in the potential of this compound to be a component in the transformation of the treatment of chronic HCV. Gilead's established expertise and leadership in the field of antiviral drug development and commercialization, coupled with the company's existing portfolio of promising compounds for HCV, make this partnership an ideal step to fully realize the potential of our promising molecules as part of future all-oral combination therapies for millions of patients in need around the world."
Gilead's research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV. Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Gilead is focused on advancing multiple compounds with different mechanisms of action and resistance profiles in combinations that will support delivery of an all-oral regimen that would eliminate the need for pegylated interferon. Three separate all-oral Phase 2 studies are currently ongoing, and Gilead expects clinical data from these studies to become available in 2012 and early 2013. Pharmasset's compounds are complementary to Gilead's existing HCV portfolio, and the transaction will help advance Gilead's effort to develop an all-oral regimen for the treatment of HCV.
Terms of the Transaction
Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Pharmasset's common stock at a price of $137 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.
The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Pharmasset shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act, and other customary conditions. The tender offer is not subject to a financing condition.
The $137 per share price in the transaction represents an 89% premium to Pharmasset's closing share price on Friday, November 18, 2011, the last trading day prior to announcement, and 59% to Pharmasset's all time high closing stock price.
Gilead has received commitments from Bank of America Merrill Lynch and Barclays Capital in connection with financing of the transaction.
Barclays Capital and Bank of America Merrill Lynch are acting as financial advisors to Gilead in the transaction. Morgan Stanley & Co. LLC is acting as the financial advisor to Pharmasset. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to Gilead and Sullivan & Cromwell LLP is serving as legal counsel to Pharmasset.
Conference Call
Gilead will host a conference call today, Monday, November 21, 2011, at 8:00 a.m. Eastern Time, to discuss the proposed acquisition. To access the live call, please dial 1-800-599-9829 (U.S.) or 1-617-847-8703 (international). The conference passcode number is 61526607. Telephone replay is available approximately one hour after the call through 11:00 a.m. Eastern Time, November 24, 2011. To access, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international). The conference passcode number for the replay is 39677531. The information provided on the teleconference is only accurate at the time of the conference call, and Gilead will take no responsibility for providing updated information.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Pharmasset's research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Forward-Looking Statement
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 factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies' and members of their senior management team. Forward-looking statements include, without limitation, statements regarding business combination and similar transactions, prospective performance and opportunities and the outlook for the companies' businesses, including, without limitation, the ability of Gilead to advance Pharmasset's product pipeline or develop an all-oral antiviral regimen for HCV, performance and opportunities and regulatory approvals, the anticipated timing of data from clinical data; the possibility of unfavorable results of the companies' clinical trials; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Pharmasset's stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, customers, other business partners or governmental entities; other business effects, including the effects of industry, economic or political conditions outside of the companies' control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies' periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to the companies, and the companies assume no obligation to update any such forward-looking statements.
Additional Information and Where to Find It
The tender offer described in this document has not yet commenced. This announcement is neither an offer to purchase nor a solicitation of an offer to sell shares of Pharmasset. At the time the offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission, and Pharmasset will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the offer. Pharmasset stockholders and other investors are urged to read the tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other offer documents) and the Solicitation/Recommendation Statement because they will contain important information which should be read carefully before any decision is made with respect to the tender offer. The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all stockholders of Pharmasset at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the Commission's web site at www.sec.gov. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Pharmasset file annual, quarterly and special reports, proxy statements and other information with the Securities and Exchange Commission. You may read and copy any reports, statements or other information filed by Gilead or Pharmasset at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Gilead's and Pharmasset's filings with the Commission are also available to the public from commercial document-retrieval services and at the website maintained by the Commission at www.sec.gov.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.
Gilead
Susan Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)
or
Pharmasset
Richard E.T. Smith, 609-865-0693 (Investors)
or
Sard Verbinnen & Co
Andrew Cole/Chris Kittredge, 212-687-8080 (Media)
Gilead Sciences to Acquire Pharmasset, Inc. for $11 Billion
- Accelerates Development of All-Oral Regimen for the Treatment of HCV -
- Leverages Gilead's Infrastructure and Expertise in Antiviral Drug Development, Manufacturing and Commercialization -
FOSTER CITY, Calif. & PRINCETON, N.J., Nov 21, 2011 (BUSINESS WIRE) --
Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) announced today that the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash. The transaction, which values Pharmasset at approximately $11 billion, was unanimously approved by Pharmasset's Board of Directors. Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes. The company expects the transaction, when completed, to be dilutive to Gilead's earnings through 2014 and accretive in 2015 and beyond. Further guidance will be provided when the transaction closes, which is expected to be in the first quarter of 2012.
Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.
"The acquisition of Pharmasset represents an important and exciting opportunity to accelerate Gilead's effort to change the treatment paradigm for HCV-infected patients by developing all-oral regimens for the treatment of the disease regardless of viral genotype," said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead. "Pharmasset presented compelling Phase 2 data earlier this month further characterizing the strong efficacy and safety profile of PSI-7977. The compound, together with Pharmasset's other pipeline candidates, represents a strong strategic fit with Gilead's vision, pipeline and capabilities. This transaction will serve to drive the long-term growth of our business, and we look forward to working closely with the Pharmasset team to advance a broad clinical program in HCV to address the unmet needs of patients and the medical community."
"We are excited to join together with Gilead, which shares our commitment to providing HCV patients with new, highly efficacious and safe oral therapies," said Schaefer Price, President and Chief Executive Officer, Pharmasset. "We are very encouraged by the data from our Phase 2 studies of PSI-7977 and believe strongly in the potential of this compound to be a component in the transformation of the treatment of chronic HCV. Gilead's established expertise and leadership in the field of antiviral drug development and commercialization, coupled with the company's existing portfolio of promising compounds for HCV, make this partnership an ideal step to fully realize the potential of our promising molecules as part of future all-oral combination therapies for millions of patients in need around the world."
Gilead's research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV. Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Gilead is focused on advancing multiple compounds with different mechanisms of action and resistance profiles in combinations that will support delivery of an all-oral regimen that would eliminate the need for pegylated interferon. Three separate all-oral Phase 2 studies are currently ongoing, and Gilead expects clinical data from these studies to become available in 2012 and early 2013. Pharmasset's compounds are complementary to Gilead's existing HCV portfolio, and the transaction will help advance Gilead's effort to develop an all-oral regimen for the treatment of HCV.
Terms of the Transaction
Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Pharmasset's common stock at a price of $137 per share in cash. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.
The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Pharmasset shares on a fully diluted basis, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act, and other customary conditions. The tender offer is not subject to a financing condition.
The $137 per share price in the transaction represents an 89% premium to Pharmasset's closing share price on Friday, November 18, 2011, the last trading day prior to announcement, and 59% to Pharmasset's all time high closing stock price.
Gilead has received commitments from Bank of America Merrill Lynch and Barclays Capital in connection with financing of the transaction.
Barclays Capital and Bank of America Merrill Lynch are acting as financial advisors to Gilead in the transaction. Morgan Stanley & Co. LLC is acting as the financial advisor to Pharmasset. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to Gilead and Sullivan & Cromwell LLP is serving as legal counsel to Pharmasset.
Conference Call
Gilead will host a conference call today, Monday, November 21, 2011, at 8:00 a.m. Eastern Time, to discuss the proposed acquisition. To access the live call, please dial 1-800-599-9829 (U.S.) or 1-617-847-8703 (international). The conference passcode number is 61526607. Telephone replay is available approximately one hour after the call through 11:00 a.m. Eastern Time, November 24, 2011. To access, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international). The conference passcode number for the replay is 39677531. The information provided on the teleconference is only accurate at the time of the conference call, and Gilead will take no responsibility for providing updated information.
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Pharmasset's research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Forward-Looking Statement
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 factors. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including all statements regarding the intent, belief or current expectation of the companies' and members of their senior management team. Forward-looking statements include, without limitation, statements regarding business combination and similar transactions, prospective performance and opportunities and the outlook for the companies' businesses, including, without limitation, the ability of Gilead to advance Pharmasset's product pipeline or develop an all-oral antiviral regimen for HCV, performance and opportunities and regulatory approvals, the anticipated timing of data from clinical data; the possibility of unfavorable results of the companies' clinical trials; filings and approvals relating to the transaction; the expected timing of the completion of the transaction; the ability to complete the transaction considering the various closing conditions; and any assumptions underlying any of the foregoing. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Pharmasset's stockholders will tender their stock in the offer; the possibility that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of the transaction on relationships with employees, customers, other business partners or governmental entities; other business effects, including the effects of industry, economic or political conditions outside of the companies' control; transaction costs; actual or contingent liabilities; and other risks and uncertainties detailed from time to time in the companies' periodic reports filed with the Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to the companies, and the companies assume no obligation to update any such forward-looking statements.
Additional Information and Where to Find It
The tender offer described in this document has not yet commenced. This announcement is neither an offer to purchase nor a solicitation of an offer to sell shares of Pharmasset. At the time the offer is commenced, Gilead will file a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission, and Pharmasset will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the offer. Pharmasset stockholders and other investors are urged to read the tender offer materials (including an Offer to Purchase, a related Letter of Transmittal and certain other offer documents) and the Solicitation/Recommendation Statement because they will contain important information which should be read carefully before any decision is made with respect to the tender offer. The Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all stockholders of Pharmasset at no expense to them. The Tender Offer Statement and the Solicitation/Recommendation Statement will be made available for free at the Commission's web site at www.sec.gov. Free copies of these materials and certain other offering documents will be made available by Gilead by mail to Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, attention: Investor Relations.
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other offer documents, as well as the Solicitation/Recommendation Statement, Gilead and Pharmasset file annual, quarterly and special reports, proxy statements and other information with the Securities and Exchange Commission. You may read and copy any reports, statements or other information filed by Gilead or Pharmasset at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the public reference room. Gilead's and Pharmasset's filings with the Commission are also available to the public from commercial document-retrieval services and at the website maintained by the Commission at www.sec.gov.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.
Gilead
Susan Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)
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Richard E.T. Smith, 609-865-0693 (Investors)
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Saturday, November 19, 2011
Achillion Is in Talks With Potential Buyers or Partners...
This is a follow-up to the Motley Fool article I posted in the LinkedIn version of this blog, which proposed a more pragmatic approach to potential buyers or partners for Achillion drugs. Greenspan's "irrational exuberance" quote does come to mind here as larger companies race to get a competitive edge in the HCV marketplace. HCV drug development has particularly been unkind to Novartis, one of the rumored suitors named in this article.
Achillion Is in Talks With Potential Buyers or Partners
Nov. 18 (Bloomberg) -- Achillion Pharmaceuticals Inc., expecting clinical data on three experimental hepatitis C therapies, is in “advanced discussions” with potential partners and acquirers, Chief Executive Officer Michael Kishbauch said. The shares jumped 8.2 percent.
If the results, due about year’s end, are positive, “we become a probable ‘transactable’ company,” Kishbauch said yesterday in an interview at the Achillion’s headquarters in New Haven, Connecticut. “We’re prepared to be patient and pick the best deal.”
Licensing deals, asset sales or selling the entire company are all possibilities, Kishbauch said. Achillion doesn’t have any products on the market. The board’s preference would be for “simplicity,” he said, referring to a full sale.
“The nature of discussions suggests that’s most likely,” he said. The question is timing, as Achillion plans to have data on a combination of hepatitis C therapies by the middle of 2013. “Theoretically the value of the company is increasing” as those results approach, he said.
Achillion rose 44 cents to $5.84 at the close of trading in New York, for the biggest gain since Oct. 27. The shares have gained 41 percent this year.
The company had a market value earlier today of about $370 million, and could command double that in a sale, said Y. Katherine Xu, an analyst with William Blair & Co. in New York.
Awaiting Data
Data on the three experimental medicines would provide a “definitive point for people who want to take a look at the assets,” Xu said in a telephone interview today. Potential suitors may include GlaxoSmithKline Plc and Novartis AG, drugmakers that have interest in hepatitis C, with programs too early in development to be competitive, Xu said.
“They’re kind of losing the game and they have to do something,” Xu said. Achillion’s medicines “could be competitive. We just don’t know the data yet.”
“We don’t comment on rumors and speculation,” Eric Althoff, a spokesman for Basel, Switzerland-based Novartis, said by phone today. David Daley, a spokesman for Glaxo in London, couldn’t immediately be reached for comment.
--With assistance from Simeon Bennett in Geneva and Makiko Kitamura in London. Editors: Bruce Rule, Chris Staiti
To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Achillion Is in Talks With Potential Buyers or Partners
Nov. 18 (Bloomberg) -- Achillion Pharmaceuticals Inc., expecting clinical data on three experimental hepatitis C therapies, is in “advanced discussions” with potential partners and acquirers, Chief Executive Officer Michael Kishbauch said. The shares jumped 8.2 percent.
If the results, due about year’s end, are positive, “we become a probable ‘transactable’ company,” Kishbauch said yesterday in an interview at the Achillion’s headquarters in New Haven, Connecticut. “We’re prepared to be patient and pick the best deal.”
Licensing deals, asset sales or selling the entire company are all possibilities, Kishbauch said. Achillion doesn’t have any products on the market. The board’s preference would be for “simplicity,” he said, referring to a full sale.
“The nature of discussions suggests that’s most likely,” he said. The question is timing, as Achillion plans to have data on a combination of hepatitis C therapies by the middle of 2013. “Theoretically the value of the company is increasing” as those results approach, he said.
Achillion rose 44 cents to $5.84 at the close of trading in New York, for the biggest gain since Oct. 27. The shares have gained 41 percent this year.
The company had a market value earlier today of about $370 million, and could command double that in a sale, said Y. Katherine Xu, an analyst with William Blair & Co. in New York.
Awaiting Data
Data on the three experimental medicines would provide a “definitive point for people who want to take a look at the assets,” Xu said in a telephone interview today. Potential suitors may include GlaxoSmithKline Plc and Novartis AG, drugmakers that have interest in hepatitis C, with programs too early in development to be competitive, Xu said.
“They’re kind of losing the game and they have to do something,” Xu said. Achillion’s medicines “could be competitive. We just don’t know the data yet.”
“We don’t comment on rumors and speculation,” Eric Althoff, a spokesman for Basel, Switzerland-based Novartis, said by phone today. David Daley, a spokesman for Glaxo in London, couldn’t immediately be reached for comment.
--With assistance from Simeon Bennett in Geneva and Makiko Kitamura in London. Editors: Bruce Rule, Chris Staiti
To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Friday, November 18, 2011
Bioethics and the use of Chimpanzees in Hepatitis C-related research...
A sobering article from BioEdge.org, a website that focuses on bioethics. There is a tremendous amount of talk regarding Direct Acting Antivirals in development, especially now that we are in the afterglow of data, post-AASLD. What has significantly less mindshare is the pre-clinical processes behind those compounds including research on animals. This article focuses on the ethical implications of animal research within the realm of HCV drug development
Chimpanzee hepatitis C research in the firing line
by Jared Yee | 18 Nov 2011 |
Experiments on chimpanzees have often horrified animal rights advocates and worried the medical community. One story brings the panorama of concerns to light – the story of Katrina. At 9 months, the chimpanzee Katrina was taken from her mother and taken to a New York laboratory – where scientists began disease testing on her. She was infected with hepatitis B,hepatitis C, and HIV. After years of testing, sedation, biopsies, and pain, she was retired in 2002 at the age of 20. However, eight years later, she was sent back to the laboratory.
Last year it emerged that Katrina and 201 other chimpanzees would be sent to the Southwest National Primate Research Centre, for hepatitis C research duties. Debate has since flared, and many are now reflecting on the ethical implications of chimpanzee testing. HIV testing on apes proved ineffective, and better alternatives existed for malaria testing. However, the most contentious disease is hepatitis C. Spread by blood-to-blood contact, hepatitis C kills 340,000 people around the world each year. There is no vaccine, and the chimpanzee is the only non-human animal that can be infected with hepatitis C. But whether chimpanzees are genuinely effective test subjects is hotly debated.
“In the US today, there are far more deaths due to the hepatitis C virus than HIV,” says virologist Stanley Lemon, of the University of North Carolina. “There’s no dispute about the ethical issues. The question is how you balance the need to recognize that with the potential for direct human benefit.” Hubert Blum, hepatologist at the University of Freiburg, said: “Chimpanzees for many reasons are no more the most important model for HCV infection… The possibility to infect cells in culture has revolutionized HCV research, especially in terms of testing antiviral agents.”
Bioethicist Ronald Green of Dartmouth College said:
“There must be overwhelming benefit for something that is truly injurious. I would think a requirement is to look upon these animals as very, very close to human research subjects. You don’t impose the same standards of research as on human subjects – but you’re not totally remote from that. I’d want to ask what the alternatives are, and a clear demonstration that this information is crucial to the control of disease. I’m not an opponent, but the benefits need to be immense.” ~ Wired, Nov 14
Chimpanzee hepatitis C research in the firing line
by Jared Yee | 18 Nov 2011 |
Experiments on chimpanzees have often horrified animal rights advocates and worried the medical community. One story brings the panorama of concerns to light – the story of Katrina. At 9 months, the chimpanzee Katrina was taken from her mother and taken to a New York laboratory – where scientists began disease testing on her. She was infected with hepatitis B,hepatitis C, and HIV. After years of testing, sedation, biopsies, and pain, she was retired in 2002 at the age of 20. However, eight years later, she was sent back to the laboratory.
Last year it emerged that Katrina and 201 other chimpanzees would be sent to the Southwest National Primate Research Centre, for hepatitis C research duties. Debate has since flared, and many are now reflecting on the ethical implications of chimpanzee testing. HIV testing on apes proved ineffective, and better alternatives existed for malaria testing. However, the most contentious disease is hepatitis C. Spread by blood-to-blood contact, hepatitis C kills 340,000 people around the world each year. There is no vaccine, and the chimpanzee is the only non-human animal that can be infected with hepatitis C. But whether chimpanzees are genuinely effective test subjects is hotly debated.
“In the US today, there are far more deaths due to the hepatitis C virus than HIV,” says virologist Stanley Lemon, of the University of North Carolina. “There’s no dispute about the ethical issues. The question is how you balance the need to recognize that with the potential for direct human benefit.” Hubert Blum, hepatologist at the University of Freiburg, said: “Chimpanzees for many reasons are no more the most important model for HCV infection… The possibility to infect cells in culture has revolutionized HCV research, especially in terms of testing antiviral agents.”
Bioethicist Ronald Green of Dartmouth College said:
“There must be overwhelming benefit for something that is truly injurious. I would think a requirement is to look upon these animals as very, very close to human research subjects. You don’t impose the same standards of research as on human subjects – but you’re not totally remote from that. I’d want to ask what the alternatives are, and a clear demonstration that this information is crucial to the control of disease. I’m not an opponent, but the benefits need to be immense.” ~ Wired, Nov 14
The Motley Fool preaches pragmatism to potential Achillion suitors...
This Biotech Stock Rose for All the Wrong Reasons
By Brian Orelli | More Articles
November 18, 2011
Achillion Pharmaceuticals (Nasdaq: ACHN ) might get bought, according to an article by Bloomberg. Shares jumped by as much as 17% today in response to the report, although it's pulled back a little since then.
And this is news because?
Achillion has three drugs in the clinic, which all treat hepatitis C, a disease that's quickly moving toward cocktail therapies as a standard of care. Pharmasset (Nasdaq: VRUS ) has separate partnerships with Johnson & Johnson (NYSE: JNJ ) and Bristol-Myers Squibb (NYSE: BMY ) to test its drug in combination with the big pharmas. Roche just bought Anadys Pharmaceuticals for its hepatitis C drug to be used in combination with its drugs and with drugs developed by Merck (NYSE: MRK ) , with which it has a partnership. Vertex Pharmaceuticals (Nasdaq: VRTX ) licensed compounds from Alios BioPharma. And the list goes on.
I'd expect Achillion to be talking with potential partners, and I'd expect that many of those companies would entertain the idea of purchasing the company at the right price.
What I don't expect is for a company's CEO to go blabbing to the media about it. There's just no reason for it.
And there's no reason for investors to jump onboard expecting that a sale is imminent. BioSante Pharmaceuticals' (Nasdaq: BPAX ) CEO made similar comments to the same news organization, causing its shares to spike in July, but shares have since fallen 40% from the high set that month.
Achillion expects to report interim phase 2 data by the end of the year for its lead compound ACH-1625. Most -- dare I say all -- potential buyers would want to see that data before making a purchase. And unless the purchase price was out of this world, Achillion's board would be crazy to agree to a sale with the data on the horizon. Assuming it's positive, the data will only make the company more valuable as a potential takeout target.
If you're going to purchase shares of Achillion, I'd consider looking for a pullback before jumping in. You might not get one -- sometimes rumors are true, and the phase 2 data will be available soon -- but I don't see how Achillion is more valuable after the Bloomberg report than it was yesterday.
By Brian Orelli | More Articles
November 18, 2011
Achillion Pharmaceuticals (Nasdaq: ACHN ) might get bought, according to an article by Bloomberg. Shares jumped by as much as 17% today in response to the report, although it's pulled back a little since then.
And this is news because?
Achillion has three drugs in the clinic, which all treat hepatitis C, a disease that's quickly moving toward cocktail therapies as a standard of care. Pharmasset (Nasdaq: VRUS ) has separate partnerships with Johnson & Johnson (NYSE: JNJ ) and Bristol-Myers Squibb (NYSE: BMY ) to test its drug in combination with the big pharmas. Roche just bought Anadys Pharmaceuticals for its hepatitis C drug to be used in combination with its drugs and with drugs developed by Merck (NYSE: MRK ) , with which it has a partnership. Vertex Pharmaceuticals (Nasdaq: VRTX ) licensed compounds from Alios BioPharma. And the list goes on.
I'd expect Achillion to be talking with potential partners, and I'd expect that many of those companies would entertain the idea of purchasing the company at the right price.
What I don't expect is for a company's CEO to go blabbing to the media about it. There's just no reason for it.
And there's no reason for investors to jump onboard expecting that a sale is imminent. BioSante Pharmaceuticals' (Nasdaq: BPAX ) CEO made similar comments to the same news organization, causing its shares to spike in July, but shares have since fallen 40% from the high set that month.
Achillion expects to report interim phase 2 data by the end of the year for its lead compound ACH-1625. Most -- dare I say all -- potential buyers would want to see that data before making a purchase. And unless the purchase price was out of this world, Achillion's board would be crazy to agree to a sale with the data on the horizon. Assuming it's positive, the data will only make the company more valuable as a potential takeout target.
If you're going to purchase shares of Achillion, I'd consider looking for a pullback before jumping in. You might not get one -- sometimes rumors are true, and the phase 2 data will be available soon -- but I don't see how Achillion is more valuable after the Bloomberg report than it was yesterday.
Project ECHO Standardizes Best Practices
From MD News.com A very nice piece on Project ECHO and it's director, Sanjeev Arora, MD. The program has been a great success in bringing Hepatitis C best practices to remote and rural areas. It appears that the model is being explored for other disease states.
Project ECHO Standardizes Best Practices
By: Conner Armstrong
Thursday, November 17, 2011
Best practice care rarely reaches rural healthcare markets. Project ECHO changes that.
In 2004, less than 5% of the approximately 28,000 New Mexico residents with hepatitis C had been treated—none of them by a local primary care physician. Project ECHO reached out to this market by developing a method for training local medical teams in hepatitis C treatment. Using web-based software and teleclinics, ECHO effectively provides medical staff in underserved areas with an experiential version of distance learning.
“Based on our studies, clinicians who we helped were as capable as specialists,” observes Sanjeev Arora, MD, FACP, FACG, director of Project ECHO. “After we had so much success with managing hepatitis C, we’ve recycled the ECHO model to deal with other diseases.”
Expanded ECHO
Project ECHO now services more than 300 sites across New Mexico by offering best practice care to patients with asthma, HIV, diabetes, and several other diseases. Factors such as case numbers, management complexity, and likelihood of societal impact help determine which diseases Project ECHO targets.
Fringe Benefits
“The potential benefits of the ECHO model are both immediate and long-term,” Arora says. “We could be changing the design of health care for years.”
Some of the benefits include:
*expansion of services to rural areas
*integration of public health into the treatment paradigm
*marketable rural workforce
*reduced testing and travel costs
*support for the medical home model
Project ECHO Standardizes Best Practices
By: Conner Armstrong
Thursday, November 17, 2011
Best practice care rarely reaches rural healthcare markets. Project ECHO changes that.
In 2004, less than 5% of the approximately 28,000 New Mexico residents with hepatitis C had been treated—none of them by a local primary care physician. Project ECHO reached out to this market by developing a method for training local medical teams in hepatitis C treatment. Using web-based software and teleclinics, ECHO effectively provides medical staff in underserved areas with an experiential version of distance learning.
“Based on our studies, clinicians who we helped were as capable as specialists,” observes Sanjeev Arora, MD, FACP, FACG, director of Project ECHO. “After we had so much success with managing hepatitis C, we’ve recycled the ECHO model to deal with other diseases.”
Expanded ECHO
Project ECHO now services more than 300 sites across New Mexico by offering best practice care to patients with asthma, HIV, diabetes, and several other diseases. Factors such as case numbers, management complexity, and likelihood of societal impact help determine which diseases Project ECHO targets.
Fringe Benefits
“The potential benefits of the ECHO model are both immediate and long-term,” Arora says. “We could be changing the design of health care for years.”
Some of the benefits include:
*expansion of services to rural areas
*integration of public health into the treatment paradigm
*marketable rural workforce
*reduced testing and travel costs
*support for the medical home model
Medscape article: Adverse CNS Effects of HCV Treatment Discourage Adherence
Medscape interviews clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City and Raymond Chung, MD,vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston regarding a large prospective study looking at CNS effects of Peg + riba and the resulting effect on adherence because of depression and/or 'brain fog'.
Adverse CNS Effects of HCV Treatment Discourage Adherence
Neil Canavan
November 18, 2011 (San Francisco, California) — Patients infected with hepatitis C virus (HCV) can experience a marked decline in neuropsychological cognitive function in the first 14 weeks of combination pegylated interferon and ribavirin therapy. This poses a potential treat to treatment adherence, said clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City, here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
These data are from a large prospective study looking at early treatment discontinuation and the onset of neuropsychiatric symptomatology in HCV monoinfected and HCV/HIV coinfected treatment-naïve patients receiving combination pegylated interferon/ribavirin therapy, Dr. Weiss explained.
"A lot of work has focused on depression, and not to the decrements in cognitive function," said Dr. Weiss. A host of neuropsychiatric symptoms should be considered when initiating a new treatment.
"In this era of direct-acting antivirals, when we're asking patients to take medications 3 times a day (every 6 to 9 hours)..., we need to be aware that, just at baseline, 40% to 50% of patients...[have] substantial deficits in cognitive functioning."
This investigation established the degree of neurocognitive decline during the first 12 and 48 weeks of treatment. Both HCV-infected and HCV/HIV-coinfected patients were evaluated. Neuropsychological instruments were used to explore which domains of cognitive functioning are most affected by combination pegylated interferon/ribavirin treatment, and whether being coinfected with HIV adds to the decrements in cognitive functioning.
There were no significant differences at baseline between the HCV-infected and HCV/HIV-coinfected cohorts for age, sex distribution, ethnicity, HCV RNA viral load, HCV genotype, or stage of liver disease. There were also no differences between the 2 groups at baseline for neuropsychological scores. However, although the same percentage of patients in the HCV and HCV/HIV cohorts reported depression, HCV patients had significantly worse depression scores.
After treatment, global neuropsychological function declined significantly in HCV patients during the first 24 weeks of HCV treatment. Domains with the greatest declines were memory, executive function, and motor function. "The HCV monoinfected group also had a greater decline in neuropsychological function than the coinfected group in the first 12 weeks," said Dr. Weiss. "This is probably due to more depression among HCV patients at baseline."
How a patient's declining neuropsychological function affects their behavior is key, and can depend on clinical history, Dr. Weiss explained. "Patients who have a history of cognitive dysfunction might respond less to the onset of new symptoms. Patients with a significant pathology who are already well engaged in psychiatric treatment tend to do quite well on [antiretroviral] treatment because they are familiar with the symptoms and are being well managed." Those who are high functioning at baseline will have more trouble; to be successfully managed, the healthcare provider must be aware of the potential for central nervous system (CNS)-related treatment nonadherence.
CNS and the Hepatologist
Raymond T. Chung, MD, vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston, agrees that the hepatologist must be part psychiatrist. "We field these patients rather then pass them off since there can often be overlap with true advanced hepatic disease and hepatic encephalopathy."
He is mindful of the potential impact of HCV medications. "It has been a modest issue with both HCV/HIV and HCV alone." Symptoms are often called "brain fog," Dr. Chung explained. "This fog does get in the way, in high-functioning individuals, of their ability to carry out intricate calculative functions and memory at work, for instance." It would not be surprising for such a patient to become frustrated and consider forgoing medication, he observed.
Dr. Chung considers the issue manageable if it is proactively addressed. However, like many clinicians at the meeting, he's looking more toward preventing than managing adverse effects by eliminating pegylated interferon from standard HCV treatment.
Dr. Weiss reports being a consultant for Vertex Pharmaceuticals and Kadmon Pharmaceuticals. Dr. Chung has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 972. November 6, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Adverse CNS Effects of HCV Treatment Discourage Adherence
Neil Canavan
November 18, 2011 (San Francisco, California) — Patients infected with hepatitis C virus (HCV) can experience a marked decline in neuropsychological cognitive function in the first 14 weeks of combination pegylated interferon and ribavirin therapy. This poses a potential treat to treatment adherence, said clinical psychologist Jeffrey J. Weiss, PhD, MS, from Mount Sinai School of Medicine in New York City, here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
These data are from a large prospective study looking at early treatment discontinuation and the onset of neuropsychiatric symptomatology in HCV monoinfected and HCV/HIV coinfected treatment-naïve patients receiving combination pegylated interferon/ribavirin therapy, Dr. Weiss explained.
"A lot of work has focused on depression, and not to the decrements in cognitive function," said Dr. Weiss. A host of neuropsychiatric symptoms should be considered when initiating a new treatment.
"In this era of direct-acting antivirals, when we're asking patients to take medications 3 times a day (every 6 to 9 hours)..., we need to be aware that, just at baseline, 40% to 50% of patients...[have] substantial deficits in cognitive functioning."
This investigation established the degree of neurocognitive decline during the first 12 and 48 weeks of treatment. Both HCV-infected and HCV/HIV-coinfected patients were evaluated. Neuropsychological instruments were used to explore which domains of cognitive functioning are most affected by combination pegylated interferon/ribavirin treatment, and whether being coinfected with HIV adds to the decrements in cognitive functioning.
There were no significant differences at baseline between the HCV-infected and HCV/HIV-coinfected cohorts for age, sex distribution, ethnicity, HCV RNA viral load, HCV genotype, or stage of liver disease. There were also no differences between the 2 groups at baseline for neuropsychological scores. However, although the same percentage of patients in the HCV and HCV/HIV cohorts reported depression, HCV patients had significantly worse depression scores.
After treatment, global neuropsychological function declined significantly in HCV patients during the first 24 weeks of HCV treatment. Domains with the greatest declines were memory, executive function, and motor function. "The HCV monoinfected group also had a greater decline in neuropsychological function than the coinfected group in the first 12 weeks," said Dr. Weiss. "This is probably due to more depression among HCV patients at baseline."
How a patient's declining neuropsychological function affects their behavior is key, and can depend on clinical history, Dr. Weiss explained. "Patients who have a history of cognitive dysfunction might respond less to the onset of new symptoms. Patients with a significant pathology who are already well engaged in psychiatric treatment tend to do quite well on [antiretroviral] treatment because they are familiar with the symptoms and are being well managed." Those who are high functioning at baseline will have more trouble; to be successfully managed, the healthcare provider must be aware of the potential for central nervous system (CNS)-related treatment nonadherence.
CNS and the Hepatologist
Raymond T. Chung, MD, vice chief of the gastrointestinal unit and medical director of the liver transplant program at Massachusetts General Hospital in Boston, agrees that the hepatologist must be part psychiatrist. "We field these patients rather then pass them off since there can often be overlap with true advanced hepatic disease and hepatic encephalopathy."
He is mindful of the potential impact of HCV medications. "It has been a modest issue with both HCV/HIV and HCV alone." Symptoms are often called "brain fog," Dr. Chung explained. "This fog does get in the way, in high-functioning individuals, of their ability to carry out intricate calculative functions and memory at work, for instance." It would not be surprising for such a patient to become frustrated and consider forgoing medication, he observed.
Dr. Chung considers the issue manageable if it is proactively addressed. However, like many clinicians at the meeting, he's looking more toward preventing than managing adverse effects by eliminating pegylated interferon from standard HCV treatment.
Dr. Weiss reports being a consultant for Vertex Pharmaceuticals and Kadmon Pharmaceuticals. Dr. Chung has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting. Abstract 972. November 6, 2011.
Medscape Medical News © 2011 WebMD, LLC
Send comments and news tips to news@medscape.net.
Wedbush analyst Duane Nash talks, people listen... Idenix stock rises.
(I wish I had that kind of power. Wedbush analyst Duane Nash recommends Idenix stock. He feels that Idenix's nucleotide inhibitor IDX184 is currently ripe for partnership and cites Pharmasset's partnership with BMS and J&J with PSI-7977 as a prime example of small pharma partnering with Big Pharma to leverage economies of scale on the development and commercialization front.)
Idenix rises as analyst looks to partnerships
NEW YORK
Shares of Idenix Pharmaceuticals Inc. rose Tuesday after an analyst upgraded the stock, saying the company's experimental hepatitis C drug may become a hot commodity in 2012.
THE SPARK: Wedbush analyst Duane Nash raised his rating on Idenix shares to "Outperform" from "Neutral." Nash said big drugmakers will be interested in the heptatitis drug, now called IDX184. After Idenix reports more data on the drug candidate, he said, it could find a marketing partner or a company interested in acquiring the drug outright. He raised his price target on Idenix shares to $11 from $6.
The company plans to report early results from a mid-stage trial of IDX184 during the first quarter of 2012.
THE BIG PICTURE: Throughout this year, companies like Pharmasset Inc. have been reporting strong clinical trial data for new hepatitis C drugs. Some of those drugs, including Pharmasset's PSI-7977 and Idenix's IDX184, are nucleotide drugs designed to prevent the hepatitis C virus from making copies of itself. Vertex Pharmaceuticals Inc.'s new hepatitis C drug Incivek also stops the virus from replicating, but it attacks a different part of the virus' genome and is not a nucleotide drug.
Nash said the data will get large pharmaceutical companies interested in nucleotide drugs. However there are not many of them available: Pharmasset already has development partnerships with Bristol-Myers Squibb Co. and Johnson & Johnson, and several other drug companies have similar partnerships.
Nash said only two companies are running clinical trials of a nucleotide drug that is not already partnered: Idenix and Inhibitex Inc.
"Due to the growing likelihood that (nucleotide drugs) will be essential for interferon-free therapy, and combined with the scarcity value of available nucs, we are increasingly optimistic that IDX184 will be partnered or acquired in 2012," Nash wrote.
Idenix spokeswoman Kelly Barry said the company has "multiple ongoing discussions with potential partners."
SHARE ACTION: Shares of the Cambridge, Mass., company picked up 26 cents, or 3.9 percent, to $7 in afternoon trading. Earlier in the session, the stock reached a three-year high of $7.38.
Idenix rises as analyst looks to partnerships
NEW YORK
Shares of Idenix Pharmaceuticals Inc. rose Tuesday after an analyst upgraded the stock, saying the company's experimental hepatitis C drug may become a hot commodity in 2012.
THE SPARK: Wedbush analyst Duane Nash raised his rating on Idenix shares to "Outperform" from "Neutral." Nash said big drugmakers will be interested in the heptatitis drug, now called IDX184. After Idenix reports more data on the drug candidate, he said, it could find a marketing partner or a company interested in acquiring the drug outright. He raised his price target on Idenix shares to $11 from $6.
The company plans to report early results from a mid-stage trial of IDX184 during the first quarter of 2012.
THE BIG PICTURE: Throughout this year, companies like Pharmasset Inc. have been reporting strong clinical trial data for new hepatitis C drugs. Some of those drugs, including Pharmasset's PSI-7977 and Idenix's IDX184, are nucleotide drugs designed to prevent the hepatitis C virus from making copies of itself. Vertex Pharmaceuticals Inc.'s new hepatitis C drug Incivek also stops the virus from replicating, but it attacks a different part of the virus' genome and is not a nucleotide drug.
Nash said the data will get large pharmaceutical companies interested in nucleotide drugs. However there are not many of them available: Pharmasset already has development partnerships with Bristol-Myers Squibb Co. and Johnson & Johnson, and several other drug companies have similar partnerships.
Nash said only two companies are running clinical trials of a nucleotide drug that is not already partnered: Idenix and Inhibitex Inc.
"Due to the growing likelihood that (nucleotide drugs) will be essential for interferon-free therapy, and combined with the scarcity value of available nucs, we are increasingly optimistic that IDX184 will be partnered or acquired in 2012," Nash wrote.
Idenix spokeswoman Kelly Barry said the company has "multiple ongoing discussions with potential partners."
SHARE ACTION: Shares of the Cambridge, Mass., company picked up 26 cents, or 3.9 percent, to $7 in afternoon trading. Earlier in the session, the stock reached a three-year high of $7.38.
Tuesday, November 15, 2011
Medivir updates investors on Hepatitis C programs...
Medivir offers an update on it's HCV development projects including the phase IIb trials for it's once daily. HCV protease inhibitor TMC435 and the early development programs for it's HCV nucleoside and a nucleotide inhibitors. For TMC435: results from the PILLAR trial looking at TMC435 + P/R in treatment naive genotype 1 subjects found 81-86% of patients achieved SVR24, compared to 65% in the placebo + P/R arm. A majority of patients (86%) in the TMC435 treatment arms had a shortened treatment duration of treatment (24 weeks), compared to a 48 weeks in the placebo + P/R arm. For the ASPIRE trial, looking at TMC435 + P/R in partial and null responders to previous treatment. The TMC435 subgroups achieved substantially higher viral cure rates (SVR24) compared to the control group (PegIFN and RBV alone): 85% vs. 37% in prior relapsers, 75% vs. 9% in prior partial responders and 51% vs. 19% in prior null responders. Other interesting notes include a change in primary endpoint from SVR24 to SVR12 in the TMC435 Phase III trials; a Phase III TMC435 + P/R vs Telaprevir + P/R in nonresponders yet to be started; an interferon-free, combination trial looking at TMC435 + Pharmasset's PSI-7977 with and without ribavirin in genotype 1 non-responders. We're likely to see more companies pair combinations of drugs as the 2nd and 3rd generation DAAs move forward in development and others are abandoned due to inferior efficacy and/or side effect issues.
Medivir: Key News from the Ongoing Capital Markets Day
HUDDINGE, Sweden, Nov 15, 2011 (BUSINESS WIRE) -- Regulatory News:
Medivir AB, a research-based speciality pharmaceutical company focused on infectious diseases, reports the following key news concerning their hepatitis C projects.
Medivir programmes in collaboration with Tibotec Pharmaceuticals Medivir and Tibotec Pharmaceuticals have two programmes for the development of antiviral therapies for future treatment of hepatitis C (HCV), these are based on the HCV protease and polymerase drug targets.
In the protease project, TMC435 is in global phase III development in both treatment naive and in patients that have relapsed after previous treatment with pegylated interferon (PegIFN) and ribavirin (RBV) in patients with chronic hepatitis C genotype 1.
The HCV polymerase collaboration program consists of two early development projects, a nucleoside and a nucleotide inhibitor.
TMC435 (NS3/4A protease inhibitor) presently in development in Hepatitis C genotype 1 infected patients.
Phase IIb studies Final SVR24 data from the phase IIb study PILLAR, in treatment-naive patients, was presented last week at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, CA, USA. Results from this final PILLAR analysis showed that TMC435 administered in combination with peginterferon a-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR, with the majority of TMC435 patients able to shorten total treatment duration to 24 weeks based on response-guided therapy.
-- In the 150 mg TMC435 treatment groups, 81-86 percent of patients achieved SVR24, compared to 65 percent of patients treated in the placebo arm. In addition, 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R.
-- The once daily dosed TMC435 was generally safe and well tolerated at all doses and treatment durations.
Medivir recently issued a press release on final results from phase IIb study ASPIRE This trial evaluated TMC435 once daily in addition to pegylated interferon (PegIFN) and ribavirin (RBV) in patients with chronic hepatitis C whose prior treatment with PegIFN and RBV was unsuccessful either because they relapsed, had a partial response or had a null response.
-- Data from the ASPIRE study showed that patients in each of these subgroups who were treated with TMC435-based combination therapy achieved superior rates of sustained virologic response (viral cure) compared to those retreated with pegylated-interferon and ribavirin alone.
-- All TMC435 subgroups achieved substantially higher viral cure rates (SVR24) compared to control group (PegIFN and RBV alone): 85% vs. 37% in prior relapsers, 75% vs. 9% in prior partial responders and 51% vs. 19% in prior null responders.
-- The once daily TMC435 was generally safe and well tolerated at all doses and treatment durations. Phase III studies
SVR12 - new endpoint
-- In the ongoing phase III studies in naive and patients that have relapsed following previous treatment, the primary endpoint has been changed from SVR24 to SVR12 following recent discussions with the FDA. These studies (QUEST 1 &2 and PROMISE) were all fully recruited in August.
Phase III study in non-responder patients to be initiated
-- Phase III study in prior partial and null responder HCV genotype 1 patients will start within six months. This study will evaluate efficacy, safety and tolerability for TMC435 vs telaprevir in combination with PegINFa-2a and Ribavirin in chronic Hepatitis C patients.
Phase II interferon free combination study with TMC435 and PSI-7977
-- This interferon free phase II combination study will commence shortly. It will evaluate TMC435 and PSI-7977 in combination with and without ribavirin for 12 and 24 weeks in genotype 1 patients who had a prior null response to Peg-IFN/RBV. The study design is now posted on www.clinicaltrials.gov .
HCV polymerase collaboration
TMC649128 TMC649128, the first NS5B nucleoside polymerase inhibitor under the collaboration, entered into clinical development in Q1-2011. It was safe and well tolerated at all doses tested for up to 14 days. However the antiviral activity failed to meet the target product profile and therefore the clinical development has now been discontinued.
Nucleotide program The focus of HCV polymerase collaboration is now on a liver targeted nucleotide polymerase inhibitor program. A clinical candidate has been selected and the project is now in preclinical development stage.
Capital Markets Day Presentation The presentation from this research & development update is available on our website under the heading Investor Relations / Latest Events.
For more information about Medivir, please visit the Company's website: www.medivir.com .
This information was brought to you by Cision http://www.cisionwire.com
SOURCE: Medivir
Medivir: Key News from the Ongoing Capital Markets Day
HUDDINGE, Sweden, Nov 15, 2011 (BUSINESS WIRE) -- Regulatory News:
Medivir AB, a research-based speciality pharmaceutical company focused on infectious diseases, reports the following key news concerning their hepatitis C projects.
Medivir programmes in collaboration with Tibotec Pharmaceuticals Medivir and Tibotec Pharmaceuticals have two programmes for the development of antiviral therapies for future treatment of hepatitis C (HCV), these are based on the HCV protease and polymerase drug targets.
In the protease project, TMC435 is in global phase III development in both treatment naive and in patients that have relapsed after previous treatment with pegylated interferon (PegIFN) and ribavirin (RBV) in patients with chronic hepatitis C genotype 1.
The HCV polymerase collaboration program consists of two early development projects, a nucleoside and a nucleotide inhibitor.
TMC435 (NS3/4A protease inhibitor) presently in development in Hepatitis C genotype 1 infected patients.
Phase IIb studies Final SVR24 data from the phase IIb study PILLAR, in treatment-naive patients, was presented last week at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, CA, USA. Results from this final PILLAR analysis showed that TMC435 administered in combination with peginterferon a-2a and ribavirin (PR) resulted in significantly higher sustained virologic response (SVR) rates compared to placebo plus PR, with the majority of TMC435 patients able to shorten total treatment duration to 24 weeks based on response-guided therapy.
-- In the 150 mg TMC435 treatment groups, 81-86 percent of patients achieved SVR24, compared to 65 percent of patients treated in the placebo arm. In addition, 86 percent of patients in the TMC435 treatment arms had a shortened treatment duration of 24 weeks, compared to a 48 weeks treatment duration for patients who received placebo plus P/R.
-- The once daily dosed TMC435 was generally safe and well tolerated at all doses and treatment durations.
Medivir recently issued a press release on final results from phase IIb study ASPIRE This trial evaluated TMC435 once daily in addition to pegylated interferon (PegIFN) and ribavirin (RBV) in patients with chronic hepatitis C whose prior treatment with PegIFN and RBV was unsuccessful either because they relapsed, had a partial response or had a null response.
-- Data from the ASPIRE study showed that patients in each of these subgroups who were treated with TMC435-based combination therapy achieved superior rates of sustained virologic response (viral cure) compared to those retreated with pegylated-interferon and ribavirin alone.
-- All TMC435 subgroups achieved substantially higher viral cure rates (SVR24) compared to control group (PegIFN and RBV alone): 85% vs. 37% in prior relapsers, 75% vs. 9% in prior partial responders and 51% vs. 19% in prior null responders.
-- The once daily TMC435 was generally safe and well tolerated at all doses and treatment durations. Phase III studies
SVR12 - new endpoint
-- In the ongoing phase III studies in naive and patients that have relapsed following previous treatment, the primary endpoint has been changed from SVR24 to SVR12 following recent discussions with the FDA. These studies (QUEST 1 &2 and PROMISE) were all fully recruited in August.
Phase III study in non-responder patients to be initiated
-- Phase III study in prior partial and null responder HCV genotype 1 patients will start within six months. This study will evaluate efficacy, safety and tolerability for TMC435 vs telaprevir in combination with PegINFa-2a and Ribavirin in chronic Hepatitis C patients.
Phase II interferon free combination study with TMC435 and PSI-7977
-- This interferon free phase II combination study will commence shortly. It will evaluate TMC435 and PSI-7977 in combination with and without ribavirin for 12 and 24 weeks in genotype 1 patients who had a prior null response to Peg-IFN/RBV. The study design is now posted on www.clinicaltrials.gov .
HCV polymerase collaboration
TMC649128 TMC649128, the first NS5B nucleoside polymerase inhibitor under the collaboration, entered into clinical development in Q1-2011. It was safe and well tolerated at all doses tested for up to 14 days. However the antiviral activity failed to meet the target product profile and therefore the clinical development has now been discontinued.
Nucleotide program The focus of HCV polymerase collaboration is now on a liver targeted nucleotide polymerase inhibitor program. A clinical candidate has been selected and the project is now in preclinical development stage.
Capital Markets Day Presentation The presentation from this research & development update is available on our website under the heading Investor Relations / Latest Events.
For more information about Medivir, please visit the Company's website: www.medivir.com .
This information was brought to you by Cision http://www.cisionwire.com
SOURCE: Medivir
Monday, November 14, 2011
UBS analysts see bright future in GSK's Promacta for HCV treatment-associated thrombocytopenia...
Article from Bloomberg.com. UBS analysts see potential 'blockbuster' status from GSK's Eltrombopag in the treatment of HCV treatment-associated thrombocytopenia.
Glaxo’s Promacta May Turn Into Blockbuster Medicine, UBS Says
By Makiko Kitamura
Nov. 7 (Bloomberg) -- GlaxoSmithKline Plc’s Promacta blood disorder medicine may generate as much as $2 billion in annual sales if the U.K.’s largest drugmaker can expand its use to the treatment of a condition associated with hepatitis C, according to UBS AG.
The medicine, already approved for sale in the U.S. to raise platelet counts in patients with a rare blood disorder, is being studied to extend use to patients with thrombocytopenia, a blood complication stemming from hepatitis C treatments. Glaxo will present results from the last of three stages of clinical testing required for regulatory approval on the new use at a medical meeting in San Francisco today.
As many as 170 million people worldwide are chronically infected with the hepatitis C virus, which can lead to cirrhosis of the liver and liver cancer, according to the World Health Organization. Glaxo’s Promacta would enable hepatitis C patients to be treated with antiviral medicines for longer periods of time, turning the drug into a “potential blockbuster,” said Gbola Amusa, a health-care analyst at UBS in London.
“Depending on how positive the data are, this could generate an additional $2 billion in annual sales,” Amusa said. Promacta had sales of 51 million pounds ($82 million) through the end of September, compared with 31 million pounds in 2010.
The study results are slated to be presented at the American Association for the Study of Liver Diseases’ annual Liver Meeting at 3:15 p.m. San Francisco time.
Sales Estimate
If the data are positive, an approval by regulators may come as early as the end of next year, Amusa said. The sales estimate assumes that antiviral medicines including interferon will continue to dominate hepatitis C treatments, Amusa said. Abbott Laboratories last month presented interim study results for a new alternative therapy that does not use interferon.
“Undoubtedly, this would be a big potential opportunity for the drug if it demonstrates strong results,” said Gustav Ando, a health-care analyst at consulting company IHS Global Insight in London. “We remain somewhat cautious until we see some of the side-effects data.”
Any potential damage to the liver in terms of toxicity along with blood clotting are of concern, Amusa and Ando said.
Glaxo said on Oct. 26 it plans to file as many as 10 drugs for approval next year. The compounds in late-stage development include Relovair, which Glaxo is developing as a successor to the Advair asthma inhaler. Advair, Glaxo’s best-selling product, generated 19 percent of total revenue in the first half of the year.
Three Glaxo products have been cleared for sale this year, including Benlysta, a therapy for the auto-immune disease lupus that was approved by U.S. regulators in March. The company’s global sales in the quarter ended Sept. 30 rose 4.3 percent to 7.1 billion pounds from a year earlier.
--Editors: Bruce Rule, Kristen Hallam
To contact the reporter responsible for this story: Makiko Kitamura in London at mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
Glaxo’s Promacta May Turn Into Blockbuster Medicine, UBS Says
By Makiko Kitamura
Nov. 7 (Bloomberg) -- GlaxoSmithKline Plc’s Promacta blood disorder medicine may generate as much as $2 billion in annual sales if the U.K.’s largest drugmaker can expand its use to the treatment of a condition associated with hepatitis C, according to UBS AG.
The medicine, already approved for sale in the U.S. to raise platelet counts in patients with a rare blood disorder, is being studied to extend use to patients with thrombocytopenia, a blood complication stemming from hepatitis C treatments. Glaxo will present results from the last of three stages of clinical testing required for regulatory approval on the new use at a medical meeting in San Francisco today.
As many as 170 million people worldwide are chronically infected with the hepatitis C virus, which can lead to cirrhosis of the liver and liver cancer, according to the World Health Organization. Glaxo’s Promacta would enable hepatitis C patients to be treated with antiviral medicines for longer periods of time, turning the drug into a “potential blockbuster,” said Gbola Amusa, a health-care analyst at UBS in London.
“Depending on how positive the data are, this could generate an additional $2 billion in annual sales,” Amusa said. Promacta had sales of 51 million pounds ($82 million) through the end of September, compared with 31 million pounds in 2010.
The study results are slated to be presented at the American Association for the Study of Liver Diseases’ annual Liver Meeting at 3:15 p.m. San Francisco time.
Sales Estimate
If the data are positive, an approval by regulators may come as early as the end of next year, Amusa said. The sales estimate assumes that antiviral medicines including interferon will continue to dominate hepatitis C treatments, Amusa said. Abbott Laboratories last month presented interim study results for a new alternative therapy that does not use interferon.
“Undoubtedly, this would be a big potential opportunity for the drug if it demonstrates strong results,” said Gustav Ando, a health-care analyst at consulting company IHS Global Insight in London. “We remain somewhat cautious until we see some of the side-effects data.”
Any potential damage to the liver in terms of toxicity along with blood clotting are of concern, Amusa and Ando said.
Glaxo said on Oct. 26 it plans to file as many as 10 drugs for approval next year. The compounds in late-stage development include Relovair, which Glaxo is developing as a successor to the Advair asthma inhaler. Advair, Glaxo’s best-selling product, generated 19 percent of total revenue in the first half of the year.
Three Glaxo products have been cleared for sale this year, including Benlysta, a therapy for the auto-immune disease lupus that was approved by U.S. regulators in March. The company’s global sales in the quarter ended Sept. 30 rose 4.3 percent to 7.1 billion pounds from a year earlier.
--Editors: Bruce Rule, Kristen Hallam
To contact the reporter responsible for this story: Makiko Kitamura in London at mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
DAA market whispers...
My affinity for robust data is only usurped somewhat by my affinity for market trends. Although my sample size is incredibly small and my methods are unscientific and most likely engulfed in torrents of biases, there are a few things that seem to be happening in the DAA market that I'd like to present to you all for input. Depending on the response, I'll propose more.
1. Interferon may be going the way of the dinosaur for treatment of HCV, but ribavirin is here to stay. At least for the foreseeable future.
2. New Rx's for the DAAs have leveled off and may continue grow slower than anticipated. Victrelis may gain share against Incivek, also conversely to 'expert' forecast.
Feel free to share your thoughts.
1. Interferon may be going the way of the dinosaur for treatment of HCV, but ribavirin is here to stay. At least for the foreseeable future.
2. New Rx's for the DAAs have leveled off and may continue grow slower than anticipated. Victrelis may gain share against Incivek, also conversely to 'expert' forecast.
Feel free to share your thoughts.
Milk Thistle shows no effect according to data presented at AASLD...
(From MEDPAGE.com: Data from AASLD concludes that silymarin. the active compound in the botanical Milk Thistle long believed to have antiviral and liver rejuvenating effects has neither compared to placebo. Important info for patients long misled by claims from unscrupulous vendors)
SAN FRANCISCO -- A botanical agent used in the treatment of liver disorders had no detectable effect on hepatitis C virus (HCV) disease activity in comparison with placebo in patients with previously treated chronic disease, results of a randomized trial showed.
Patients treated for six months with either of two doses of silymarin had little change in levels of the liver enzyme alanine transaminase (ALT). About 4% of patients in each silymarin arm and in the placebo group met the primary endpoint of a decline in ALT to ≤45 IU or at least a 50% decline from baseline.
"Similarly, symptom scores and quality of life measures were unchanged during silymarin treatment," Michael W. Fried, MD, of the University of North Carolina in Chapel Hill, reported here at the American Association for the Study of Liver Diseases meeting.
The trial was perhaps the first to use a single, well-described silymarin preparation, and the doses employed in the study were five to seven times higher than customary doses, he added.
Silymarin is an extract of milk thistle and has long been used as a treatment for various types of liver disorders. A mixture of flavonolignans, silymarin has demonstrated anti-inflammatory and immunodulatory properties in vitro, as well as activity against the HCV core and virus-associated gene expression.
The substance has been evaluated in clinical trials as a therapeutic aid for cirrhosis, alcoholic liver disease, and viral hepatitis. However, the results have been inconsistent.
"Previous studies have been confounded by a lack of well-defined efficacy endpoints, inclusion of heterogeneous populations of patients with liver disease, and use of nonstandardized silymarin preparations," said Fried.
To address some of the shortcomings of previous clinical studies, the investigators designed a trial to evaluate silymarin as a potential aid in the treatment of chronic HCV that had not responded to interferon-based therapy.
All of the 154 patients enrolled at four centers in the U.S. had a history of treatment with interferon-based therapy and had not achieved a sustained virologic response. The patients had quantifiable HCV RNA and a serum ALT ≥65 IU.
The silymarin preparation used for the trial is produced in the Netherlands under the brand name Legalon 140 and is approved as a prescription drug in some European and Asian countries. The customary dose is 140 mg three times a day.
Eligible patients were randomized to one of two doses of silymarin (420 or 700 mg) or placebo. Patients in the high-dose silymarin arm took five capsules of the botanical agent three times daily. Patients randomized to the standard dose took three silymarin capsules and two placebo capsules three times each day, and patients in the placebo arm took five matching capsules three times daily.
The high-dose arm was based on results from a phase I dose-finding trial "in order to provide the highest likelihood of finding a therapeutic benefit," said Fried.
The primary endpoint, measured after 24 weeks, was a decline in serum ALT to ≤45 IU (the upper limit of normal) or a decline of at least 50% from baseline and <65 IU (1.5 times the upper limit of normal).
The patients were randomized to the three treatment arms. The three groups did not differ with respect to baseline demographic and clinical characteristics. Median age was 55, about 70% were white, about 90% had HCV genotype 1, about a fourth of the patients had evidence of cirrhosis, and 40% to 45% had a history of milk thistle use.
Adherence was good, said Fried, as about 90% of the study participants consumed more than 80% of their medication doses.
After six months, one person in the placebo group had a serum ALT ≤45 IU, as did two patients in each of the silymarin arms. Additionally, two patients in the placebo and high-dose silymarin groups had at least a 50% decline in baseline ALT to <65 IU, as did one patient in the 420-mg silymarin arm.
The proportion of patients who met either definition of the primary endpoint was 3.8% (two of 52) in the placebo group, 4% (two of 50) in the 420-mg silymarin arm, and 3.8% (two of 52) in the high-dose silymarin arm.
The three groups also did not differ significantly with respect to the mean change in ALT, change in HCV RNA, or scores on a battery of quality-of-life instruments. A graph of serum ALT levels throughout the six months showed virtually superimposable lines for the three groups.
The placebo and silymarin groups also did not differ significantly in their adverse-event profiles. The most common types of adverse events were gastrointestinal, musculoskeletal, dermatologic, infection, and physical injury. Six patients in the 420-mg silymarin arm and five in the 700-mg arm had serious adverse events, compared with one in the placebo group.
During the discussion that followed the presentation, Fried expressed doubt that using even higher doses of silymarin might lead to better results, as suggested by a member of the audience.
AASLD president T. Jake Liang, MD, said the study is informative because the results showed not only that silymarin performed no better than placebo in a well-controlled clinical trial but also that the substance is not harmful for people who take it for liver conditions.
SAN FRANCISCO -- A botanical agent used in the treatment of liver disorders had no detectable effect on hepatitis C virus (HCV) disease activity in comparison with placebo in patients with previously treated chronic disease, results of a randomized trial showed.
Patients treated for six months with either of two doses of silymarin had little change in levels of the liver enzyme alanine transaminase (ALT). About 4% of patients in each silymarin arm and in the placebo group met the primary endpoint of a decline in ALT to ≤45 IU or at least a 50% decline from baseline.
"Similarly, symptom scores and quality of life measures were unchanged during silymarin treatment," Michael W. Fried, MD, of the University of North Carolina in Chapel Hill, reported here at the American Association for the Study of Liver Diseases meeting.
The trial was perhaps the first to use a single, well-described silymarin preparation, and the doses employed in the study were five to seven times higher than customary doses, he added.
Silymarin is an extract of milk thistle and has long been used as a treatment for various types of liver disorders. A mixture of flavonolignans, silymarin has demonstrated anti-inflammatory and immunodulatory properties in vitro, as well as activity against the HCV core and virus-associated gene expression.
The substance has been evaluated in clinical trials as a therapeutic aid for cirrhosis, alcoholic liver disease, and viral hepatitis. However, the results have been inconsistent.
"Previous studies have been confounded by a lack of well-defined efficacy endpoints, inclusion of heterogeneous populations of patients with liver disease, and use of nonstandardized silymarin preparations," said Fried.
To address some of the shortcomings of previous clinical studies, the investigators designed a trial to evaluate silymarin as a potential aid in the treatment of chronic HCV that had not responded to interferon-based therapy.
All of the 154 patients enrolled at four centers in the U.S. had a history of treatment with interferon-based therapy and had not achieved a sustained virologic response. The patients had quantifiable HCV RNA and a serum ALT ≥65 IU.
The silymarin preparation used for the trial is produced in the Netherlands under the brand name Legalon 140 and is approved as a prescription drug in some European and Asian countries. The customary dose is 140 mg three times a day.
Eligible patients were randomized to one of two doses of silymarin (420 or 700 mg) or placebo. Patients in the high-dose silymarin arm took five capsules of the botanical agent three times daily. Patients randomized to the standard dose took three silymarin capsules and two placebo capsules three times each day, and patients in the placebo arm took five matching capsules three times daily.
The high-dose arm was based on results from a phase I dose-finding trial "in order to provide the highest likelihood of finding a therapeutic benefit," said Fried.
The primary endpoint, measured after 24 weeks, was a decline in serum ALT to ≤45 IU (the upper limit of normal) or a decline of at least 50% from baseline and <65 IU (1.5 times the upper limit of normal).
The patients were randomized to the three treatment arms. The three groups did not differ with respect to baseline demographic and clinical characteristics. Median age was 55, about 70% were white, about 90% had HCV genotype 1, about a fourth of the patients had evidence of cirrhosis, and 40% to 45% had a history of milk thistle use.
Adherence was good, said Fried, as about 90% of the study participants consumed more than 80% of their medication doses.
After six months, one person in the placebo group had a serum ALT ≤45 IU, as did two patients in each of the silymarin arms. Additionally, two patients in the placebo and high-dose silymarin groups had at least a 50% decline in baseline ALT to <65 IU, as did one patient in the 420-mg silymarin arm.
The proportion of patients who met either definition of the primary endpoint was 3.8% (two of 52) in the placebo group, 4% (two of 50) in the 420-mg silymarin arm, and 3.8% (two of 52) in the high-dose silymarin arm.
The three groups also did not differ significantly with respect to the mean change in ALT, change in HCV RNA, or scores on a battery of quality-of-life instruments. A graph of serum ALT levels throughout the six months showed virtually superimposable lines for the three groups.
The placebo and silymarin groups also did not differ significantly in their adverse-event profiles. The most common types of adverse events were gastrointestinal, musculoskeletal, dermatologic, infection, and physical injury. Six patients in the 420-mg silymarin arm and five in the 700-mg arm had serious adverse events, compared with one in the placebo group.
During the discussion that followed the presentation, Fried expressed doubt that using even higher doses of silymarin might lead to better results, as suggested by a member of the audience.
AASLD president T. Jake Liang, MD, said the study is informative because the results showed not only that silymarin performed no better than placebo in a well-controlled clinical trial but also that the substance is not harmful for people who take it for liver conditions.
HCV leaps ahead of HIV as leader of cause of death in the U.S.
From POZ.com. HCV surpasses HIV as a leading cause of death in the US, according to the CDC
November 10, 2011
Hepatitis C Surpasses HIV as Cause of Death in U.S.
It’s official. Chronic hepatitis C virus (HCV) infection is associated with more deaths than HIV infection, according to sobering new data presented by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday, November 8, at the 62nd annual meeting of the American Association for the Studies of Liver Diseases (AASLD) in San Francisco.
The discouraging findings, presented by Scott Holmberg, MD, MPH, chief of the CDC’s Division of Viral Hepatitis Epidemiology and Surveillance Branch, come from data involving 21.8 million deaths reported to the National Center for Health Statistics between 1999 and 2007. The only cases included in the analysis involved reports that specified HIV, AIDS, HCV or hepatitis B virus (HBV) infection as possible contributors to the deaths.
Encouragingly, death rates associated with chronic HBV infection—a major cause of liver failure and liver cancer—remained relatively flat between 1999 and 2007. In 2007, for example, about 1,800 U.S. residents died of HBV-related complications, which translated into less than one chronic hepatitis B-attributable death per 100,000 people in this country.
Death rates related to HIV infection continue to fall. Whereas HIV contributed to 6 per 100,000 deaths in 1999, the rate dropped to less than four per 100,000 deaths in 2007.
Hepatitis C–related deaths have increased sharply, Holmberg’s team reported. Whereas HCV contributed to roughly 3 per 100,000 deaths in 1999, the HCV-related death rate exceeded 4 per 100,000 people in the United States by 2007.
With respect to crude numbers, roughly 12,700 HIV-related deaths were reported to the National Center for Health Statistics in 2007. More than 15,000 HCV-related deaths were reported to the center that year.
Most viral hepatitis deaths occurred in people in the prime of their lives. About 59 percent of people who died of complications related to hepatitis B were between the ages of 45 and 64. The impact of chronic hepatitis C was even more substantial—roughly 73 percent of the deaths related to HCV were in baby boomers.
Not surprisingly, death rates were highest among certain populations. For example, people coinfected with both HBV and HCV faced a 30-fold increase in the risk of death from liver disease or related complications. Alcohol abuse was associated with a four-fold increase in the risk of death. Coinfection with HIV nearly doubled the risk of death from HBV-related complications and quadrupled the risk of death from HCV-associated liver disease.
“[Achieving] declines in mortality similar to those seen with HIV,” Holmberg’s group concluded, “will require new policy directions and commitment to detect and link infectious persons to care and successful treatment.”
November 10, 2011
Hepatitis C Surpasses HIV as Cause of Death in U.S.
It’s official. Chronic hepatitis C virus (HCV) infection is associated with more deaths than HIV infection, according to sobering new data presented by the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday, November 8, at the 62nd annual meeting of the American Association for the Studies of Liver Diseases (AASLD) in San Francisco.
The discouraging findings, presented by Scott Holmberg, MD, MPH, chief of the CDC’s Division of Viral Hepatitis Epidemiology and Surveillance Branch, come from data involving 21.8 million deaths reported to the National Center for Health Statistics between 1999 and 2007. The only cases included in the analysis involved reports that specified HIV, AIDS, HCV or hepatitis B virus (HBV) infection as possible contributors to the deaths.
Encouragingly, death rates associated with chronic HBV infection—a major cause of liver failure and liver cancer—remained relatively flat between 1999 and 2007. In 2007, for example, about 1,800 U.S. residents died of HBV-related complications, which translated into less than one chronic hepatitis B-attributable death per 100,000 people in this country.
Death rates related to HIV infection continue to fall. Whereas HIV contributed to 6 per 100,000 deaths in 1999, the rate dropped to less than four per 100,000 deaths in 2007.
Hepatitis C–related deaths have increased sharply, Holmberg’s team reported. Whereas HCV contributed to roughly 3 per 100,000 deaths in 1999, the HCV-related death rate exceeded 4 per 100,000 people in the United States by 2007.
With respect to crude numbers, roughly 12,700 HIV-related deaths were reported to the National Center for Health Statistics in 2007. More than 15,000 HCV-related deaths were reported to the center that year.
Most viral hepatitis deaths occurred in people in the prime of their lives. About 59 percent of people who died of complications related to hepatitis B were between the ages of 45 and 64. The impact of chronic hepatitis C was even more substantial—roughly 73 percent of the deaths related to HCV were in baby boomers.
Not surprisingly, death rates were highest among certain populations. For example, people coinfected with both HBV and HCV faced a 30-fold increase in the risk of death from liver disease or related complications. Alcohol abuse was associated with a four-fold increase in the risk of death. Coinfection with HIV nearly doubled the risk of death from HBV-related complications and quadrupled the risk of death from HCV-associated liver disease.
“[Achieving] declines in mortality similar to those seen with HIV,” Holmberg’s group concluded, “will require new policy directions and commitment to detect and link infectious persons to care and successful treatment.”
Wednesday, November 9, 2011
New MEDSCAPE article sheds more light on PSI-7977 and the ELECTRON trial...
Pharmasset launched a broadside in the HCV drug development wars during AASLD, revealing that some patients may be able to achieve and SVR without the use of interferon. This was according to nterim results from the phase II ELECTRON trial, looking at Pharmasset's nucleotide inhibitor PSI-7977 in various combinations with ribavirin and interferon/no interferon in different Hepatitis C genotypes. In one arm, PSI-7977 plus ribavirin was administered for 12 weeks in 10 genotype 2 and 3 patients. This article sheds further light on those patients - in short, they were genotype 2/3, tx-naïve without cirrhosis. They had a mean age of 47 years, mean baseline HCV RNA was 6.49 log10 IU/mL, and roughly 43% had the favorable 'CC genotype' associated with favorable response to standard interferon-based therapy. The author also interviews lead PI Edward Gane, MD and gets 'too good to be true?' thoughts from Michael Bernstein, MD who was involved in the NM-286 clinical trials.
From Medscape Medical News
New HCV Drug Achieves 100% Cure Rate Without Interferon
Neil Canavan
November 9, 2011 (San Francisco, California) — An interferon-free regimen for the treatment of infection with hepatitis C virus (HCV) might soon be available, according to data from the ELECTRON trial, presented here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
In ELECTRON — 1 of 2 phase 2 studies of the investigational compound PSI-7977 (Pharmasset) reported here — an interferon-free regimen of PSI-7977 plus ribavirin achieved a 100% sustained viral response (SVR) at 12 weeks in all study subjects.
"PSI-7977 has the potential to dramatically change the treatment paradigm for HCV," said lead study investigator Edward Gane, MD, from Auckland City Hospital in New Zealand.
PSI-7977 is a uridine nucleotide analog polymerase inhibitor that is administered once daily with or without food. It has demonstrated robust activity in patients infected with HCV genotype 1 when used in combination with pegylated-interferon and ribavirin after a 12-week course.
Activity with this agent used as a monotherapy has also been reported.
"The aim of the ELECTRON trial was to determine the shortest duration of interferon, if any, required to achieve SVR when PSI-7977 plus ribavirin are administered for 12 weeks," Dr. Gane explained.
ELECTRON investigators recruited 40 patients who were randomized to 1 of 4 treatment groups: PSI-7977 400 mg plus ribavirin for 12 weeks plus interferon for 0, 4, 8, or 12 weeks.
Patients were treatment-naïve, noncirrhotic, infected with HCV genotype 2 or 3, and stratified by interleukin (IL)28B single-nucleotide polymorphisms (SNP) and HCV RNA levels. Mean age was 47 years and mean baseline HCV RNA was 6.49 log10 IU/mL, with 42.5% exhibiting the CC genotype at the IL28B SNP.
"We selected a genotype 2/3 population because this represents a population that would be more easily rescued with interferon in the event of virologic breakthrough," Dr. Gane explained.
Results after treatment initiation were dramatic. "All patients achieved a rapid virologic response, with over 80% being nondetectable at 2 weeks," reported Dr. Gane.
All patients had undetectable HCV at 3 weeks; furthermore, all patients achieved end-of-treatment response. No cases of treatment resistance were observed.
"Even following cessation of interferon, or with no interferon, there were no virologic breakthroughs on treatment." Also encouraging was the fact that all patients in the study experienced a rapid normalization of alanine aminotransferase.
There were no serious adverse events, and the mild to moderate events observed were attributed to either interferon or ribavirin. Significant improvements in safety and tolerability were seen in the interferon-free treatment group. No safety signals for PSI-7977 were observed, and there were no treatment-related discontinuations.
Results of the 12-week analysis prompted study investigators to add an exploratory treatment group of open-label PSI-7977 monotherapy for 12 weeks (n = 10). "The response was the same as with combination treatment with ribavirin," said Dr. Gane. Although this study is ongoing, 6 of 10 patients have achieved SVR at 4 weeks.
"These data clearly demonstrate that PSI-7977 exhibits high potency and has a high barrier to resistance," Dr. Gane said, noting that the drug is being advanced in phase 3 investigations in all HCV genotypes.
Too Good to be True?
Michael Bernstein, MD, director of the hepatitis clinic at the Coney Island Hospital, Brooklyn, New York, has doubts about PSI-7977. "If you use it with ribavirin and no interferon, you get a 100% SVR; if you use it alone, you get a 100% SVR."
Dr. Bernstein accepts the efficacy of PSI-7977 for the moment, but is concerned that ELECTRON isn't powered to say much about the tolerability or resistance profiles of the drug.
"What we've found with most of these [polymerase inhibitors] is that if you use them by themselves, you get resistance; if you don't, they can be very difficult to tolerate," said Dr. Bernstein. "There was a drug being investigated at Mount Sinai — a polymerase inhibitor, NM286 — and those patients got severe diarrhea and could not tolerate it. According to the ELECTRON study, everything was perfect — no gastrointestinal issues, no apparent adverse events of any kind, and it worked 100% of the time without interferon, or ribavirin.... If it's true, it will be great. The holy grail is to try to rid HCV treatment regimens of interferon."
Although sincerely impressed, Dr. Bernstein, who has seen many drugs come and go, suspects that as larger phase 3 trials of PSI-7977 are conducted, polymerase-associated adverse events, tolerability issues, and treatment resistance patterns will emerge.
Dr. Gane reports advisory board relationships with Pharmasset, Gilead, Roche, Janssen-Cilag, and Boehringer-Ingelheim. Dr. Bernstein has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting: Abstract 34. Presented November 6, 2011.
From Medscape Medical News
New HCV Drug Achieves 100% Cure Rate Without Interferon
Neil Canavan
November 9, 2011 (San Francisco, California) — An interferon-free regimen for the treatment of infection with hepatitis C virus (HCV) might soon be available, according to data from the ELECTRON trial, presented here at The Liver Meeting 2011: American Association for the Study of Liver Diseases 62nd Annual Meeting.
In ELECTRON — 1 of 2 phase 2 studies of the investigational compound PSI-7977 (Pharmasset) reported here — an interferon-free regimen of PSI-7977 plus ribavirin achieved a 100% sustained viral response (SVR) at 12 weeks in all study subjects.
"PSI-7977 has the potential to dramatically change the treatment paradigm for HCV," said lead study investigator Edward Gane, MD, from Auckland City Hospital in New Zealand.
PSI-7977 is a uridine nucleotide analog polymerase inhibitor that is administered once daily with or without food. It has demonstrated robust activity in patients infected with HCV genotype 1 when used in combination with pegylated-interferon and ribavirin after a 12-week course.
Activity with this agent used as a monotherapy has also been reported.
"The aim of the ELECTRON trial was to determine the shortest duration of interferon, if any, required to achieve SVR when PSI-7977 plus ribavirin are administered for 12 weeks," Dr. Gane explained.
ELECTRON investigators recruited 40 patients who were randomized to 1 of 4 treatment groups: PSI-7977 400 mg plus ribavirin for 12 weeks plus interferon for 0, 4, 8, or 12 weeks.
Patients were treatment-naïve, noncirrhotic, infected with HCV genotype 2 or 3, and stratified by interleukin (IL)28B single-nucleotide polymorphisms (SNP) and HCV RNA levels. Mean age was 47 years and mean baseline HCV RNA was 6.49 log10 IU/mL, with 42.5% exhibiting the CC genotype at the IL28B SNP.
"We selected a genotype 2/3 population because this represents a population that would be more easily rescued with interferon in the event of virologic breakthrough," Dr. Gane explained.
Results after treatment initiation were dramatic. "All patients achieved a rapid virologic response, with over 80% being nondetectable at 2 weeks," reported Dr. Gane.
All patients had undetectable HCV at 3 weeks; furthermore, all patients achieved end-of-treatment response. No cases of treatment resistance were observed.
"Even following cessation of interferon, or with no interferon, there were no virologic breakthroughs on treatment." Also encouraging was the fact that all patients in the study experienced a rapid normalization of alanine aminotransferase.
There were no serious adverse events, and the mild to moderate events observed were attributed to either interferon or ribavirin. Significant improvements in safety and tolerability were seen in the interferon-free treatment group. No safety signals for PSI-7977 were observed, and there were no treatment-related discontinuations.
Results of the 12-week analysis prompted study investigators to add an exploratory treatment group of open-label PSI-7977 monotherapy for 12 weeks (n = 10). "The response was the same as with combination treatment with ribavirin," said Dr. Gane. Although this study is ongoing, 6 of 10 patients have achieved SVR at 4 weeks.
"These data clearly demonstrate that PSI-7977 exhibits high potency and has a high barrier to resistance," Dr. Gane said, noting that the drug is being advanced in phase 3 investigations in all HCV genotypes.
Too Good to be True?
Michael Bernstein, MD, director of the hepatitis clinic at the Coney Island Hospital, Brooklyn, New York, has doubts about PSI-7977. "If you use it with ribavirin and no interferon, you get a 100% SVR; if you use it alone, you get a 100% SVR."
Dr. Bernstein accepts the efficacy of PSI-7977 for the moment, but is concerned that ELECTRON isn't powered to say much about the tolerability or resistance profiles of the drug.
"What we've found with most of these [polymerase inhibitors] is that if you use them by themselves, you get resistance; if you don't, they can be very difficult to tolerate," said Dr. Bernstein. "There was a drug being investigated at Mount Sinai — a polymerase inhibitor, NM286 — and those patients got severe diarrhea and could not tolerate it. According to the ELECTRON study, everything was perfect — no gastrointestinal issues, no apparent adverse events of any kind, and it worked 100% of the time without interferon, or ribavirin.... If it's true, it will be great. The holy grail is to try to rid HCV treatment regimens of interferon."
Although sincerely impressed, Dr. Bernstein, who has seen many drugs come and go, suspects that as larger phase 3 trials of PSI-7977 are conducted, polymerase-associated adverse events, tolerability issues, and treatment resistance patterns will emerge.
Dr. Gane reports advisory board relationships with Pharmasset, Gilead, Roche, Janssen-Cilag, and Boehringer-Ingelheim. Dr. Bernstein has disclosed no relevant financial relationships.
The Liver Meeting 2011: American Association for the Study of Liver Diseases (AASLD) 62nd Annual Meeting: Abstract 34. Presented November 6, 2011.
Monday, November 7, 2011
Pharmasset's HCV nucleotide analog PSI-7977 poised to raise the bar for HCV DAAs....
By far the biggest buzz at AASLD thus far has been the performance of Pharmasset's PSI-7977, a nucleotide analog being studied in various combinations for the treatment of chronic hepatitis C. Pharmasset released Phase II data at AASLD showing 100% SVR in a small group of genotype 2/3 patients in combination with ribavirin but without the need for interferon. The success despite the lack of interferon raised hopes for a truly interferon-free pan-genotypic treatment for HCV with once daily dosing and a minimum amount of side effects. The drug has a long way to go in development, but this data certainly buoyed hopes of patients, HCV providers and investors alike. One hopes that the data for prior non-responders (especially null-responders) and genotype 1 patients fair as well.
Twelve Weeks Interferon-Free PSI-7977 Regimen Cures 100 Percent Hep C Genotype 2/3
A twelve-week course of Pharmasset’s once-daily experimental nucleotide analog PSI-7977, combined with ribavirin, cured 10 of 10 people living with genotype 2/3 hepatitis C virus (HCV) who used the regimen—without pegylated interferon—in a Phase II clinical trial. The highly encouraging results were reported Sunday, November 6, at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
Compared with the three other groups included in the study, which involved taking PSI-7977 plus ribavirin with either four, eight or 12 weeks of pegylated interferon, significant improvements in safety and tolerability were also documented among those using PSI-7977 plus ribavirin alone, according to Edward Gane, MD, of the Auckland City Hospital in Auckland, New Zealand, and his ELECTRON study colleagues.
Results from early studies of PSI-7977 have been promising. In the PROTON study, PSI-7977 combined with pegylated interferon plus ribavirin resulted in sustained virologic responses (SVRs)—viral cures—in 96 percent of study volunteers with HCV genotype 2/3 and 91 percent of those with HCV genotype 1 (the most common yet hardest-to-treat form of the virus in the United States).
ELECTRON, initiated in December 2010, was conducted to determine the shortest duration of pegylated interferon—if any—required to achieve SVRs when PSI-7977 plus ribavirin are given for 12 weeks. HCV genotype 2/3 patients were initially selected for this unorthodox study—pegylated interferon has long been a mainstay agent in hepatitis C drug regimens—given pegylated interferon and ribavirin tend to be much more effective for individuals with genotype 2/3 virus and could be called upon in the event of poor responses to PSI-7977/ribavirin in the study.
No “rescue” therapy proved necessary. At virtually all study time points—weeks 4, 8 and 12 during therapy and weeks 4, 8, 12 and 24 following the completion of treatment—100 percent of the patients in each group maintained undetectable HCV viral loads. Eleven patients received PSI-7977/ribavirin plus 12 weeks of pegylated interferon, 10 received PSI-7977/ribavirin plus eight weeks of pegylated interferon, nine received PSI-7977/ribavirin plus pegylated interferon and ten received PSI-7977/ribavirin without pegylated interferon.
Gane noted that HCV viral load suppression was rapid in all four treatment groups—virtually everyone had HCV below the level of detection within three weeks of beginning treatment.
At least one side effect—including headache, fatigue, depression, insomnia, anxiety, irritability, muscle soreness and upper respiratory tract infections—was more likely to be documented in those in the 12-week pegylated interferon group (72 percent), compared with those who didn’t receive any pegylated interferon (40 percent).
Similarly, whereas moderate-to-severe drops in neutrophils—a type of white blood cell—was documented in roughly 70 percent of those in the 12-week pegylated interferon group, no volunteers in the interferon-free PSI-7977/ribavirin group experienced this toxicity. Interferon-free PSI-7977 plus ribavirin also had much less of an impact on hemoglobin levels, a marker of anemia.
Also encouraging, all patients in the study experienced a rapid normalization of ALT, a key liver enzyme. Among those in the interferon-free treatment group, normal ALT levels were documented in all patients by the end of the third week of treatment.
In summary, Gane noted, “PSI-7977 [400 milligrams once daily] remains very well tolerated with no attributable safety signal, no treatment discontinuations and no treatment emergency laboratory abnormalities.” As for potency, he concluded that PSI-7977/ribavirin “elicited rapid suppression” of HCV viral load in study volunteers with HCV genotype 2 or 3 and that all 40 patients in the study achieved an SVR, regardless of whether or not interferon was used. Additionally, not a single case of drug-resistant virus emerged during the study.
Further results from ELECTRON are expected. The study has been amended, adding several new treatment groups. One group is exploring PSI-7977 used as monotherapy—without pegylated interferon or ribavirin—to treat genotype 2/3 infection. Preliminary data reported by Gane's team suggest that four patients in this group have maintained undetectable HCV levels four weeks after discontinuing treatment.
Another group is studying PSI-7977 in combination with pegylated interferon plus ribavirin, again in genotype 2/3 patients, but for only eight weeks.
Three additional groups are now enrolling patients. One is studying 12 weeks of PSI-7977 plus ribavirin, without interferon, in HCV genotype 2/3 patients who weren't able to clear the virus with 24 weeks of previous pegylated interferon/ribavirin therapy. A second is evaluating PSI-7977 plus ribavirin in HCV genotype 1 patients beginning therapy for the first time. The third group consists of individuals with HCV genotype 1 null responders (patients who responded very poorly to prior pegylated interferon/ribavirin treatment); they will receive PSI-7977/ribavirin for a total of 12 weeks.
Pharmasset recently announced its Phase III clinical trial program. Two studies—FISSION and POSITRON—will further explore the safety and efficacy of PSI-7977 plus ribavirin, but without pegylated interferon, in approximately 725 people with genotype 2/3 HCV infection. A third study will explore PSI-7977 in HCV genotype 1 patients, with the design of the study determined by the ongoing ELECTRON clinical trial and another study still under way.
Read the full article here: http://www.aidsmeds.com/articles/psi7977_svr_hcv_1667_21405.shtml
Twelve Weeks Interferon-Free PSI-7977 Regimen Cures 100 Percent Hep C Genotype 2/3
A twelve-week course of Pharmasset’s once-daily experimental nucleotide analog PSI-7977, combined with ribavirin, cured 10 of 10 people living with genotype 2/3 hepatitis C virus (HCV) who used the regimen—without pegylated interferon—in a Phase II clinical trial. The highly encouraging results were reported Sunday, November 6, at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.
Compared with the three other groups included in the study, which involved taking PSI-7977 plus ribavirin with either four, eight or 12 weeks of pegylated interferon, significant improvements in safety and tolerability were also documented among those using PSI-7977 plus ribavirin alone, according to Edward Gane, MD, of the Auckland City Hospital in Auckland, New Zealand, and his ELECTRON study colleagues.
Results from early studies of PSI-7977 have been promising. In the PROTON study, PSI-7977 combined with pegylated interferon plus ribavirin resulted in sustained virologic responses (SVRs)—viral cures—in 96 percent of study volunteers with HCV genotype 2/3 and 91 percent of those with HCV genotype 1 (the most common yet hardest-to-treat form of the virus in the United States).
ELECTRON, initiated in December 2010, was conducted to determine the shortest duration of pegylated interferon—if any—required to achieve SVRs when PSI-7977 plus ribavirin are given for 12 weeks. HCV genotype 2/3 patients were initially selected for this unorthodox study—pegylated interferon has long been a mainstay agent in hepatitis C drug regimens—given pegylated interferon and ribavirin tend to be much more effective for individuals with genotype 2/3 virus and could be called upon in the event of poor responses to PSI-7977/ribavirin in the study.
No “rescue” therapy proved necessary. At virtually all study time points—weeks 4, 8 and 12 during therapy and weeks 4, 8, 12 and 24 following the completion of treatment—100 percent of the patients in each group maintained undetectable HCV viral loads. Eleven patients received PSI-7977/ribavirin plus 12 weeks of pegylated interferon, 10 received PSI-7977/ribavirin plus eight weeks of pegylated interferon, nine received PSI-7977/ribavirin plus pegylated interferon and ten received PSI-7977/ribavirin without pegylated interferon.
Gane noted that HCV viral load suppression was rapid in all four treatment groups—virtually everyone had HCV below the level of detection within three weeks of beginning treatment.
At least one side effect—including headache, fatigue, depression, insomnia, anxiety, irritability, muscle soreness and upper respiratory tract infections—was more likely to be documented in those in the 12-week pegylated interferon group (72 percent), compared with those who didn’t receive any pegylated interferon (40 percent).
Similarly, whereas moderate-to-severe drops in neutrophils—a type of white blood cell—was documented in roughly 70 percent of those in the 12-week pegylated interferon group, no volunteers in the interferon-free PSI-7977/ribavirin group experienced this toxicity. Interferon-free PSI-7977 plus ribavirin also had much less of an impact on hemoglobin levels, a marker of anemia.
Also encouraging, all patients in the study experienced a rapid normalization of ALT, a key liver enzyme. Among those in the interferon-free treatment group, normal ALT levels were documented in all patients by the end of the third week of treatment.
In summary, Gane noted, “PSI-7977 [400 milligrams once daily] remains very well tolerated with no attributable safety signal, no treatment discontinuations and no treatment emergency laboratory abnormalities.” As for potency, he concluded that PSI-7977/ribavirin “elicited rapid suppression” of HCV viral load in study volunteers with HCV genotype 2 or 3 and that all 40 patients in the study achieved an SVR, regardless of whether or not interferon was used. Additionally, not a single case of drug-resistant virus emerged during the study.
Further results from ELECTRON are expected. The study has been amended, adding several new treatment groups. One group is exploring PSI-7977 used as monotherapy—without pegylated interferon or ribavirin—to treat genotype 2/3 infection. Preliminary data reported by Gane's team suggest that four patients in this group have maintained undetectable HCV levels four weeks after discontinuing treatment.
Another group is studying PSI-7977 in combination with pegylated interferon plus ribavirin, again in genotype 2/3 patients, but for only eight weeks.
Three additional groups are now enrolling patients. One is studying 12 weeks of PSI-7977 plus ribavirin, without interferon, in HCV genotype 2/3 patients who weren't able to clear the virus with 24 weeks of previous pegylated interferon/ribavirin therapy. A second is evaluating PSI-7977 plus ribavirin in HCV genotype 1 patients beginning therapy for the first time. The third group consists of individuals with HCV genotype 1 null responders (patients who responded very poorly to prior pegylated interferon/ribavirin treatment); they will receive PSI-7977/ribavirin for a total of 12 weeks.
Pharmasset recently announced its Phase III clinical trial program. Two studies—FISSION and POSITRON—will further explore the safety and efficacy of PSI-7977 plus ribavirin, but without pegylated interferon, in approximately 725 people with genotype 2/3 HCV infection. A third study will explore PSI-7977 in HCV genotype 1 patients, with the design of the study determined by the ongoing ELECTRON clinical trial and another study still under way.
Read the full article here: http://www.aidsmeds.com/articles/psi7977_svr_hcv_1667_21405.shtml
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