Bloomberg News article published in the San Francisco Chronicle on 2/15/2012 on the recent M&As and speculation on the M&As to come. Very nice overview if you're new to the HCV drug development space and have a hankerin' to learn who the big players are.
Hepatitis C: Drugmakers jockey to create cocktail
Bloomberg News
Wednesday, February 15, 2012
A developing medical theory that hepatitis C can be overcome with the same type of drug cocktails that tamed HIV is shaking up the pharmaceutical industry.
Companies are trying to anticipate which medicines might work best together and planning their acquisition strategies accordingly. Because only a few hepatitis C drugs are approved, and others in testing may not pan out, "we don't know what the winning formula will be," said Ben Weintraub, an analyst at Wolters Kluwer InThought. To raise the odds, "companies are doing M&A (mergers and aquisitions) and starting new trials on almost a daily basis."
With more than two dozen drugs in development, doctors predict a new age of therapy for a blood-borne virus carried by 170 million people that now has few treatment options. The promise of a potential $20 billion market has already spurred three deals in the past year - the latest being Bristol-Myers Squibb's $2.5 billion purchase this month of Inhibitex.
Next in line may be Idenix Pharmaceuticals and Achillion Pharmaceuticals, said Raghuram Selvaraju, an analyst with Morgan Joseph TriArtisan.
"I don't think either of these companies will remain independent very long," Selvaraju said. "I think we'll see both of them out of there by the end of the year."
Increased urgency
Achillion is testing a so-called protease inhibitor, while Idenix is developing a nucleotide polymerase inhibitor. The two medicines, which work differently to block the virus' ability to replicate in the body, are in the second of three stages of testing normally required for U.S. approval.
By combining several classes of these new hepatitis C drugs, doctors may be able to limit the virus' ability to infect, mimicking the strategy that a decade earlier helped turn HIV from a killer disease to a controlled one, said Charles Chiu, an infectious disease doctor at UCSF.
With the success of treatments that "work on the virus itself, there's an increased urgency now to explore drugs in many different stages of the viral life cycle," Chui said.
Until last year's introduction of Victrelis from Merck and Incivek by Vertex Pharmaceuticals - two protease inhibitors - the standard treatment combined the antiviral drug ribavirin with interferon, an immune-boosting protein sold by Merck as PegIntron and by Roche as Pegasys.
That treatment relied on interferon shots given weekly for a year, and it cured only about half of patients with the most common U.S. strain, called genotype 1. The drugs also caused side effects that include fatigue and flu-like symptoms.
Across different types
The new protease inhibitors stop an enzyme that splits proteins and allows them to replicate. While they've been shown to cure more patients in less time than previous therapies, with fewer side effects, they still need to be combined with interferon shots.
Scientists see promise in the other class being developed, the nucleotide polymerase inhibitors, which bind to a different part of the virus than the protease inhibitors. These drugs are pan-genotypic - meaning they are effective across the different types of hepatitis C. They could become the backbone for an interferon-free combination.
Mixing the classes together may be even more effective in beating the disease, which is blamed for more than 350,000 deaths a year worldwide.
"We waited 15 years for protease inhibitors, and a year later we could have a new class of drugs, nucleotides, that surpass them," said Steve Worland, former CEO of Anadys Pharmaceuticals, an experimental hepatitis C drugmaker acquired by Roche in November for about $230 million. "That kind of dramatic change I have never seen before."
Drugmakers want to own a piece of the eventual cocktail that will work best among patients worldwide. They've been working in the lab to create their own drugs, as well as scouting other companies with an eye toward buying promising candidates.
Takeover targets
Foster City's Gilead Sciences paid $10.8 billion for Pharmasset last month to use its experimental nucleotide drug, PSI-7977, as a cornerstone to a new hepatitis C combination - one that it expects other drugmakers will want to use - opening the door to added licensing revenue.
Selvaraju said: "7977 is going to be the driver of an all-oral regimen, and all of these other drugs are going to be layered on top of it."
Rivals have the same idea as they hunt for potential targets. That's why Achillion and Idenix are being closely watched as potential takeover targets, Selvaraju said. Abbott Laboratories and Roche are potential bidders, he said. Merck, Bristol-Myers and Johnson & Johnson are also in pursuit of the new regimens.
The potential market size for these therapies is at least $20 billion, according to Michael Kishbauch, CEO of Achillion.
Competition grows
Gilead increased its offer to acquire Pharmasset four times last year to $137 per share from $100 per share, after a clinical trial showed PSI-7977 cured all patients in a study.
"The opportunity to be able to cure people with three months of therapy is one of the most amazing breakthroughs we can bring to health care - and there's a lot of competition," Gilead CEO John Martin said last month.
Idenix is in talks to find a partner to create a combination hepatitis C treatment, said Ron Renaud, the company's CEO. While declining to comment on whether the company may be acquired, he said interest in hepatitis C drugs picked up last year during a liver disease conference.
"There is a tremendous market opportunity here that people want to take advantage of, and there's an intense race that's under way to get to that point," Renaud said.
http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2012/02/15/BUDC1N7L0U.DTL
his article appeared on page D - 1 of the San Francisco Chronicle
Showing posts with label Roche. Show all posts
Showing posts with label Roche. Show all posts
Wednesday, February 15, 2012
Friday, December 16, 2011
Merck & Roche team up for HCV product trials..
The unlikely pairing of these former arch-enemies and Hepatitis C juggernauts Merck and Roche continue to raise eyebrows. This time, the duo had agreed to a series of planned clinical trials to investigate combinations of currently marketed and investigational compounds to treat HCV, with a focus on the genotype 1 population. The first appears to be a phase II study called DYNAMO 1, which will look at Boceprevir in combination with with Roche's mericitabine (RO5024048), their oral HCV NS5B nucleoside polymerase inhibitor in combination with pegylated interferon (Pegasys, for those keeping a scorecard) and ribavirin in genotype 1 patients with a prior null response to P/R. The fact that there doesn't appear to be an interferon-free arm leads me to believe that these two interferon giants do not believe that prior null responders can be cured without interferon, which, to their credit, may indeed be the case.
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
New Clinical Trial Will Evaluate an Investigational Therapeutic Regimen with VICTRELIS™ (boceprevir)
WHITEHOUSE STATION, N.J., Dec. 15, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck, in collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY), has initiated the first of a series of planned clinical trials to examine novel combinations of marketed and investigational medicines to expedite the availability of potential new treatment regimens for patients with chronic hepatitis C virus (HCV) genotype 1 infection. Clinical development collaboration is part of the overarching strategic agreement between Merck and Roche to improve treatment, diagnosis and awareness of chronic HCV in developed and emerging markets.
"VICTRELIS is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus," said Eliav Barr, M.D., vice president, Infectious Diseases Project Leadership and Management, Merck Research Laboratories. "The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform VICTRELIS provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasizes our ongoing commitment to seeking novel treatment options for patients with chronic HCV."
The first trial is designed to provide clinical data on the use of VICTRELIS™ (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally. For further details of the clinical trial please visit www.clinicaltrials.gov, or contact (888) 662-6728 (U.S. only) or Genentechclinicaltrials@drug info.com.
Indications and usage for VICTRELIS
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011 for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
•VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
•VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
•VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
•Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and neutropenia have been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
New Clinical Trial Will Evaluate an Investigational Therapeutic Regimen with VICTRELIS™ (boceprevir)
WHITEHOUSE STATION, N.J., Dec. 15, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Merck, in collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY), has initiated the first of a series of planned clinical trials to examine novel combinations of marketed and investigational medicines to expedite the availability of potential new treatment regimens for patients with chronic hepatitis C virus (HCV) genotype 1 infection. Clinical development collaboration is part of the overarching strategic agreement between Merck and Roche to improve treatment, diagnosis and awareness of chronic HCV in developed and emerging markets.
"VICTRELIS is the first in a new class of medicines for the treatment of chronic HCV genotype 1 infection, and when used in combination with peginterferon alfa, can significantly increase a patient's chance of achieving undetectable levels of the virus," said Eliav Barr, M.D., vice president, Infectious Diseases Project Leadership and Management, Merck Research Laboratories. "The start of this new study is an important milestone in our collaboration with Roche as we work to build on the innovative platform VICTRELIS provides by evaluating it in combination therapy with new investigational medicines for the treatment of chronic HCV genotype 1 infection, and also emphasizes our ongoing commitment to seeking novel treatment options for patients with chronic HCV."
The first trial is designed to provide clinical data on the use of VICTRELIS™ (boceprevir), an oral HCV NS3/4A protease inhibitor, in combination with mericitabine (RO5024048), Roche's investigational oral HCV NS5B nucleoside polymerase inhibitor, Pegasys® (pegylated interferon alfa-2a) and Copegus® (ribavirin), in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy (less than a 2 log HCV-RNA decline at treatment week 12). The Phase II study, called DYNAMO 1, plans to recruit patients at 25 sites globally. For further details of the clinical trial please visit www.clinicaltrials.gov, or contact (888) 662-6728 (U.S. only) or Genentechclinicaltrials@drug info.com.
Indications and usage for VICTRELIS
VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011 for the treatment of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in combination with peginterferon alfa and ribavirin (P/R), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
The following points should be considered when initiating VICTRELIS for treatment of chronic HCV infection:
•VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
•VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
•VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log viral load decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
•Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
Important safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least 6 months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS and concomitant ribavirin.
VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced VICTRELIS plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio® (sildenafil) or Adcirca® (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and neutropenia have been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations compared to peginterferon alfa and ribavirin alone and/or may result in worsening of neutropenia associated with peginterferon alfa and ribavirin therapy alone. Dose reduction or discontinuation of peginterferon alfa and/or ribavirin may be required. Dose reduction of VICTRELIS is not recommended. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
Complete blood counts (with white blood cell differential counts) must be conducted in all patients prior to initiating combination therapy with VICTRELIS. Complete blood counts should be obtained at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previous treatment-failure patients who were treated with combination therapy with VICTRELIS compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis care.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Wednesday, July 20, 2011
Merck and Roche sign global agreement to promote Victrelis...
WHITEHOUSE STATION, N.J., Jul 20, 2011 (BUSINESS WIRE) -- Merck /quotes/zigman/574389/quotes/nls/mrk MRK -0.56% , known as MSD outside the United States and Canada, announced today that it has signed a new non-exclusive agreement with Roche (six:RO)(six:ROG)(otcqx:RHHBY), through the companies' respective subsidiaries, for the global promotion, upon appropriate marketing approvals, of VICTRELIS(TM) (boceprevir) as part of a triple combination therapy regimen with peginterferon alfa and ribavirin (peg/riba).
"Reaching physicians with important information about the use of VICTRELIS in combination with peg/riba is essential as we enter this new era in the field of chronic hepatitis C," said Adam H. Schechter, executive vice president and president, Global Human Health, Merck. "We're pleased to work with Roche to help physicians help patients with chronic hepatitis C around the world."
Under the terms of the agreement, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). The companies previously announced an agreement to promote VICTRELIS in the United States and collaborate to explore new treatment regimens for patients with chronic HCV.
"Improving treatment outcomes for more patients with chronic hepatitis C is our ultimate goal," said Pascal Soriot, Roche Pharmaceuticals Division, chief operating officer. "Through this extended collaboration and the education of health care professionals, Roche and Merck aim to ensure that appropriate patients can benefit from triple combination therapy."
VICTRELIS in the United States
In the United States, VICTRELIS is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)(1) , and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
On July 18, Merck announced that the European Commission (EC) approved VICTRELIS for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least six months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
____________________ (1) SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
"Reaching physicians with important information about the use of VICTRELIS in combination with peg/riba is essential as we enter this new era in the field of chronic hepatitis C," said Adam H. Schechter, executive vice president and president, Global Human Health, Merck. "We're pleased to work with Roche to help physicians help patients with chronic hepatitis C around the world."
Under the terms of the agreement, Roche and Merck will work together in global markets, including Europe, Asia and Latin America, to educate physicians and patients about hepatitis C virus (HCV). The companies previously announced an agreement to promote VICTRELIS in the United States and collaborate to explore new treatment regimens for patients with chronic HCV.
"Improving treatment outcomes for more patients with chronic hepatitis C is our ultimate goal," said Pascal Soriot, Roche Pharmaceuticals Division, chief operating officer. "Through this extended collaboration and the education of health care professionals, Roche and Merck aim to ensure that appropriate patients can benefit from triple combination therapy."
VICTRELIS in the United States
In the United States, VICTRELIS is approved for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. The following points should be considered when initiating VICTRELIS for treatment of chronic hepatitis C infection:
-- VICTRELIS must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
-- VICTRELIS efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes VICTRELIS or other HCV NS3/4A protease inhibitors.
-- VICTRELIS in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with VICTRELIS in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR)(1) , and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
VICTRELIS was approved by the U.S. Food and Drug Administration on May 13 and is available to all U.S. pharmacies nationwide, including specialty pharmacies.
On July 18, Merck announced that the European Commission (EC) approved VICTRELIS for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Important U.S. safety information about VICTRELIS
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS must be administered with peginterferon alfa and ribavirin. Because ribavirin may cause birth defects and fetal death, VICTRELIS in combination with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men whose female partners are pregnant. Avoid pregnancy in female patients and female partners of male patients. Patients must have a negative pregnancy test prior to therapy; have monthly pregnancy tests; and use two or more forms of effective contraception, including intrauterine devices and barrier methods, during treatment and for at least six months after treatment has concluded. Systemic hormonal contraceptives may not be as effective in women while taking VICTRELIS. VICTRELIS is contraindicated in coadministration with drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events. VICTRELIS also is contraindicated in coadministration with potent CYP3A4/5 inducers where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy. Drugs that are contraindicated with VICTRELIS include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John's Wort (hypericum perforatum), lovastatin, simvastatin, drosperinone, Revatio(R) (sildenafil) or Adcirca(R) (tadalafil) (when used for the treatment of pulmonary arterial hypertension), pimozide, triazolam, and midazolam (orally administered).
Anemia has been reported with peginterferon alfa and ribavirin therapy. The addition of VICTRELIS to peginterferon alfa and ribavirin is associated with an additional decrease in hemoglobin concentrations. The addition of VICTRELIS may result in a worsening of neutropenia associated with peginterferon alfa and ribavirin alone. Complete blood counts should be obtained pretreatment, and at treatment weeks 4, 8 and 12, and should be monitored closely at other time points, as clinically appropriate. If a patient has a serious adverse reaction potentially related to peginterferon alfa and ribavirin therapy, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin.
The most commonly reported adverse reactions (greater than 35 percent) in clinical trials in adult patients receiving the combination of VICTRELIS with peginterferon alfa-2b and ribavirin were fatigue, anemia, nausea, headache and dysgeusia. Of these commonly reported adverse reactions, fatigue, anemia, nausea, and dysgeusia occurred at rates greater than or equal to 5 percent above the rates for peginterferon alfa and ribavirin alone in either clinical study. The incidence of these adverse reactions in previously untreated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30 percent), nausea (46 vs. 42 percent), dysgeusia (35 vs. 16 percent), respectively. The incidence of these adverse reactions in previously treated patients who received VICTRELIS combination therapy compared with peginterferon and ribavirin alone were: fatigue (55 vs. 50 percent), anemia (45 vs. 20 percent), nausea (43 vs. 38 percent), dysgeusia (44 vs. 11 percent), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5. The potential for drug-drug interactions must be considered prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf .
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies with VICTRELIS, extensive research efforts are underway to develop additional innovative oral therapies for viral hepatitis treatment.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com .
Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2010 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).
Please see Prescribing Information for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf .
____________________ (1) SVR, the protocol specified primary efficacy endpoint of the pivotal studies, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment in all randomized patients treated with any study medication. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.
VICTRELIS(TM) is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio(R) and Adcirca(R) are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA.
SOURCE: Merck
Tuesday, May 17, 2011
Former archenemies Merck and Roche form a Hepatitis C alliance....
Even the most casual of observers of Pharma industries machinations would have to agree that it's been a rough five days for Vertex. Their main competitor, Merck, gets first mover advantage, a best-case label, AND effectively buys loyalty in a marketing alliance with it's former archenemy, Roche. Roche gets peace of mind that Merck won't drop it's drawers on Peg-Intron and Boceprevir bundling to gain formulary access, leaving it's cash cow Pegasys out of harms way and potential for even greater sales. Vertex has to partner with Pegasys regardless of the alliance because Pegasys was the only interferon used in Telaprevir's Phase III pivotal trials. I'm not right about a whole bunch of things, more than I'd like to admit, but I've never been wrong regarding Merck as a marketing juggernaut. Genius move that may give Boceprevir greater strength against Telaprevir's sure-to-come broadsides on efficacy and dosing schedule.
Merck Girds For Hep C Battle With Roche Deal
Adam Feuerstein
05/17/11 - 12:40 PM EDT
WHITEHOUSE STATION, N.J. (TheStreet) -- Merck(MRK) gained an unlikely ally in the hyper-competitive battle to market a new crop of hepatitis C drugs.
Roche said Tuesday that it will promote in the U.S. Merck's newly approved drug Victrelis in combination with its own hepatitis C drug Pegasys under a broader marketing and research alliance signed between the two drug giants.
What makes this partnership unusual is that Roche and Merck have been long-time hepatitis C treatment competitors. The new arrangement aligns the interests of two pharmaceutical marketing powerhouses, which for Merck is especially helpful as it strikes out to compete against Vertex Pharmaceuticals(VRTX) and its new hepatitis C drug.
Roche's Pegasys, or weekly interferon injection, has about 80% market share to Merck's own long-acting interferon injection, Peg-Intron, which has about 20% market share.
Under this new agreement, Roche will be promoting the use of Merck's Victrelis in combination with Pegasys as a new, triple-combination therapy against hepatitis C. Victrelis was approved in the U.S. last Friday, making it the first in a new class of direct-acting antiviral agents against hepatitis C.
Vertex is expecting to receive similar U.S. approval on or before May 23 for its drug, Incivek. The launch of two new and similar hepatitis C drugs promises to ignite one of the fiercest drug marketing battles in years.
The Merck-Roche deal is not exclusive, which means that Roche, at some point, could agree to a similar deal with Vertex to promote Incivek. Vertex, however, may not necessarily need Roche's direct help because Incivek is already closely tied to Pegasys. Incivek's pivotal clinical trials used Roche's Pegasys as the long-acting interferon backbone, whereas Merck tested Victrelis in combination with its own Peg-Intron.
Still, bringing Roche on board to promote Victrelis is a coup for Merck because it adds a new and experienced sales force that will be able to educate doctors about how to best use Victrelis. One of the issues weighing on Merck is the complex and often confusing dosing schedules required with Victrelis as compared to a much simpler dosing schedule for Vertex's Incivek.
Victrelis and Incivek have never been compared in a head-to-head study but the Vertex drug is also widely viewed as more effective -- able to cure upwards of 80% of newly treated patients compared to an approximate 60% cure rate for Merck's drug.
Merck and Roche did not disclose financial terms of the deal but a Merck spokesman said that Merck retains 100% of the Victrelis economics even with the Roche marketing deal in place. Presumably, that means Roche will not receive a royalty on Victrelis sales but will gain as more doctors choose to use its Pegasys with either Victrelis or Incivek. Roche may have also been worried that Merck was planning to tempt doctors with a discounted bundle of Peg-Intron with Victrelis that could have hurt Pegasys market share.
Under terms of the agreement, Merck and Roche will also cooperate on new studies that will seek to combine Victrelis with Roche's experimental hepatitis C drugs. This new research alliance can include experimental drugs that Roche licensed from other companies, including one from Pharmasset(VRUS), according to a Roche spokeswoman.
--Written by Adam Feuerstein in Boston.
Merck Girds For Hep C Battle With Roche Deal
Adam Feuerstein
05/17/11 - 12:40 PM EDT
WHITEHOUSE STATION, N.J. (TheStreet) -- Merck(MRK) gained an unlikely ally in the hyper-competitive battle to market a new crop of hepatitis C drugs.
Roche said Tuesday that it will promote in the U.S. Merck's newly approved drug Victrelis in combination with its own hepatitis C drug Pegasys under a broader marketing and research alliance signed between the two drug giants.
What makes this partnership unusual is that Roche and Merck have been long-time hepatitis C treatment competitors. The new arrangement aligns the interests of two pharmaceutical marketing powerhouses, which for Merck is especially helpful as it strikes out to compete against Vertex Pharmaceuticals(VRTX) and its new hepatitis C drug.
Roche's Pegasys, or weekly interferon injection, has about 80% market share to Merck's own long-acting interferon injection, Peg-Intron, which has about 20% market share.
Under this new agreement, Roche will be promoting the use of Merck's Victrelis in combination with Pegasys as a new, triple-combination therapy against hepatitis C. Victrelis was approved in the U.S. last Friday, making it the first in a new class of direct-acting antiviral agents against hepatitis C.
Vertex is expecting to receive similar U.S. approval on or before May 23 for its drug, Incivek. The launch of two new and similar hepatitis C drugs promises to ignite one of the fiercest drug marketing battles in years.
The Merck-Roche deal is not exclusive, which means that Roche, at some point, could agree to a similar deal with Vertex to promote Incivek. Vertex, however, may not necessarily need Roche's direct help because Incivek is already closely tied to Pegasys. Incivek's pivotal clinical trials used Roche's Pegasys as the long-acting interferon backbone, whereas Merck tested Victrelis in combination with its own Peg-Intron.
Still, bringing Roche on board to promote Victrelis is a coup for Merck because it adds a new and experienced sales force that will be able to educate doctors about how to best use Victrelis. One of the issues weighing on Merck is the complex and often confusing dosing schedules required with Victrelis as compared to a much simpler dosing schedule for Vertex's Incivek.
Victrelis and Incivek have never been compared in a head-to-head study but the Vertex drug is also widely viewed as more effective -- able to cure upwards of 80% of newly treated patients compared to an approximate 60% cure rate for Merck's drug.
Merck and Roche did not disclose financial terms of the deal but a Merck spokesman said that Merck retains 100% of the Victrelis economics even with the Roche marketing deal in place. Presumably, that means Roche will not receive a royalty on Victrelis sales but will gain as more doctors choose to use its Pegasys with either Victrelis or Incivek. Roche may have also been worried that Merck was planning to tempt doctors with a discounted bundle of Peg-Intron with Victrelis that could have hurt Pegasys market share.
Under terms of the agreement, Merck and Roche will also cooperate on new studies that will seek to combine Victrelis with Roche's experimental hepatitis C drugs. This new research alliance can include experimental drugs that Roche licensed from other companies, including one from Pharmasset(VRUS), according to a Roche spokeswoman.
--Written by Adam Feuerstein in Boston.
Tuesday, March 8, 2011
Could an all-oral agent to treat HCV be on the way?
Two week interim data for Pharmasset's Interferon/Ribavirin-free nuc-nuc combo is a long way from an SVR, but so far the company has earned bragging rights by having 15/16 subjects in this early phase trial go undetectable after two weeks. This is seemingly a pretty potent combo in comparison to Vertex's data with it's nuc VX-222 + Telaprevir + Peg Interferon + Ribavirin. Depending on the arm, that data topped out at 38-57% undetectability after 14 days in comparison to 94% with PSI-938 and PSI-7977. Pharmasset’s new landmark was enough for investors to spin like tops and goose the stock to new heights. Keep in mind that investors don’t always act rationally and It’s difficult to predict outcomes as all we know regarding viral kinetics and positive/negative predictive values comes from regimens that contain peg-inf plus ribavirin as its therapeutic backbone. If PSI-938 and PSI-7977 can retain 94% undetectable at four weeks, I’ll be proportionally reassured regarding this combo’s future. It will be interesting how the company defines when it’s time to stop therapy given that there isn’t an immunomodulator aboard. At what time points will the company declare EOT and SVR? An all oral combo would be an amazing paradigm shift for this disease state and will set the bar extremely high for drug developers looking to get into the HCV therapeutic category, but there’s a long road ahead.
Pharmasset Hep C Data Wows Investors
Adam Feuerstein
03/08/11 - 11:46 AM EST
PRINCETON, N.J. (TheStreet) -- Pharmasset(VRUS) shares are soaring on the release of new but very preliminary data that hints at a breakthrough, all-oral cure for hepatitis C.
Treatment with two oral drugs developed by Pharmasset resulted in 15 of 16, or 94%, of patients reporting undetectable levels of the hepatitis C virus after 14 days, according to interim results from a study released Monday.
These early data on the two Pharmasset drugs -- PSI-938 and PSI-7977 are the best reported to date by any company seeking to develop a new, all-oral therapy for hepatitis C. This Pharmasset effort is drawing even more attention because it potentially eliminates the need for patients to be treated with long-acting interferon, one of two drugs currently used to treat hepatitis C but which is difficult for patients to tolerate and causes many side effects.
Pharmasset shares rose 24% on Monday and were up another 8% to $66.92 on Tuesday.
The PSI-938 and PSI-7977 combination data were released Monday in a research abstract released online by the European Association for the Study of the Liver (EASL), which holds its annual meeting March 30 through April 3.
EASL makes research abstracts for its annual meeting freely available to the public but prohibits journalists from writing about the data contained in the research abstracts until they are presented at the annual meeting. TheStreet refuses to adhere to EASL's media embargo since these hepatitis C data are freely available online now and are impacting the stock prices of publicly traded companies developing hepatitis C drugs.
While investors are displaying great enthusiasm for the Pharmasset all-oral drug combination, the data from the study are very early. One particular risk seen in other, similar studies that omit long-acting interferon is the development of mutated hepatitis C virus that can quickly become resistant to drug treatment.
None of the patients treated in the Pharmasset study have reported rebounding levels of hepatitis C virus, according to the research abstract, but so-called viral rebound may emerge as patients are treated longer, or when treatment is stopped and these patients are followed long-term to determine if they are truly cured.
Pharmasset owns full rights to both PSI-938 and PSI-7977. The company is developing another hepatitis C drug, RG7128, in partnership with Roche.
"We believe the full data of a 14-day combination of PSI-7977 / PSI-938 to be presented at the upcoming EASL could show proof of principle for a nuc-nuc combination and position Pharmasset as one of the front runners in the race to develop an interferon-free regimen, which is considered a Holy Grail in hepatitis C treatment," said Leerink Swann analyst Howard Liang in a note to clients Tuesday.
The EASL meeting at the end of the month will also feature data from other companies seeking to develop various combination treatments for hepatitis C.
Vertex Pharmaceuticals(VRTX) is studying a "quad" regimen consisting of two experimental drugs, VX-222 and telaprevir, combined with the current standard of care, long-acting interferon and ribavirin. An EASL research abstract released Monday reported treatment with Vertex's "quad" therapy resulted in 38-57% of patients with undetectable virus after two weeks and 86-87% undetectable after four weeks.
One potential competitive disadvantage to the Vertex quad is that patients still need to be treated with long-acting interferon, which requires weekly injections. Vertex previously reported disappointing results from an all-oral Hep C drug regimen that eliminated interferon.
Telaprevir is currently under review by regulators in the U.S. and Europe. The U.S. Food and Drug Administration is expected to make an approval decision on or before May 23.
Gilead Sciences(GILD) and Bristol-Myers Squibb(BMY) will also be presenting new data from Hep C combination drug studies at the EASL meeting later this month.
--Written by Adam Feuerstein in Boston.
Pharmasset Hep C Data Wows Investors
Adam Feuerstein
03/08/11 - 11:46 AM EST
PRINCETON, N.J. (TheStreet) -- Pharmasset(VRUS) shares are soaring on the release of new but very preliminary data that hints at a breakthrough, all-oral cure for hepatitis C.
Treatment with two oral drugs developed by Pharmasset resulted in 15 of 16, or 94%, of patients reporting undetectable levels of the hepatitis C virus after 14 days, according to interim results from a study released Monday.
These early data on the two Pharmasset drugs -- PSI-938 and PSI-7977 are the best reported to date by any company seeking to develop a new, all-oral therapy for hepatitis C. This Pharmasset effort is drawing even more attention because it potentially eliminates the need for patients to be treated with long-acting interferon, one of two drugs currently used to treat hepatitis C but which is difficult for patients to tolerate and causes many side effects.
Pharmasset shares rose 24% on Monday and were up another 8% to $66.92 on Tuesday.
The PSI-938 and PSI-7977 combination data were released Monday in a research abstract released online by the European Association for the Study of the Liver (EASL), which holds its annual meeting March 30 through April 3.
EASL makes research abstracts for its annual meeting freely available to the public but prohibits journalists from writing about the data contained in the research abstracts until they are presented at the annual meeting. TheStreet refuses to adhere to EASL's media embargo since these hepatitis C data are freely available online now and are impacting the stock prices of publicly traded companies developing hepatitis C drugs.
While investors are displaying great enthusiasm for the Pharmasset all-oral drug combination, the data from the study are very early. One particular risk seen in other, similar studies that omit long-acting interferon is the development of mutated hepatitis C virus that can quickly become resistant to drug treatment.
None of the patients treated in the Pharmasset study have reported rebounding levels of hepatitis C virus, according to the research abstract, but so-called viral rebound may emerge as patients are treated longer, or when treatment is stopped and these patients are followed long-term to determine if they are truly cured.
Pharmasset owns full rights to both PSI-938 and PSI-7977. The company is developing another hepatitis C drug, RG7128, in partnership with Roche.
"We believe the full data of a 14-day combination of PSI-7977 / PSI-938 to be presented at the upcoming EASL could show proof of principle for a nuc-nuc combination and position Pharmasset as one of the front runners in the race to develop an interferon-free regimen, which is considered a Holy Grail in hepatitis C treatment," said Leerink Swann analyst Howard Liang in a note to clients Tuesday.
The EASL meeting at the end of the month will also feature data from other companies seeking to develop various combination treatments for hepatitis C.
Vertex Pharmaceuticals(VRTX) is studying a "quad" regimen consisting of two experimental drugs, VX-222 and telaprevir, combined with the current standard of care, long-acting interferon and ribavirin. An EASL research abstract released Monday reported treatment with Vertex's "quad" therapy resulted in 38-57% of patients with undetectable virus after two weeks and 86-87% undetectable after four weeks.
One potential competitive disadvantage to the Vertex quad is that patients still need to be treated with long-acting interferon, which requires weekly injections. Vertex previously reported disappointing results from an all-oral Hep C drug regimen that eliminated interferon.
Telaprevir is currently under review by regulators in the U.S. and Europe. The U.S. Food and Drug Administration is expected to make an approval decision on or before May 23.
Gilead Sciences(GILD) and Bristol-Myers Squibb(BMY) will also be presenting new data from Hep C combination drug studies at the EASL meeting later this month.
--Written by Adam Feuerstein in Boston.
Tuesday, November 23, 2010
Roche severs HCV treatment collaboration and license agreement between with Ligand Pharma...
Drug giant Roche terminates it's treatment collaboration and license agreement with Ligand Pharma. Ligand gets a good deal, with non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales. Roche, on the other hand, is prohibited for ten years following the termination from developing or commercializing related compounds. Maybe the InterMune deal was enough? Nah. Has to be some other reason.
Tue, Nov 23 2010
* Says received a notice from Roche unit on Nov 19
* Roche prohibited to develop related compounds for 10 yrs
* Shares down 1 pct after-the-bell
Nov 23 (Reuters) - Ligand Pharmaceuticals Inc (LGNDD.O: Quote, Profile, Research) said Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research) was exercising its right to terminate the collaboration and license agreement between the two companies on developing hepatitis C treatment.
The collaboration and license agreement with Roche began in 2008 to develop new treatments for hepatitis C viral infection using liver-targeting technology.
In April, Ligand received $6.5 million milestone payment from Roche.
As per the agreement, Ligand will receive a non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales.
Roche will be prohibited for ten years following the termination from developing or commercializing related compounds, Ligand said in a regulatory filing.
Ligand said it received a notice from Roche units last Friday regarding the termination.
Ligand's shares, which have lost about 18 percent since the company got Japanese marketing nod for its blood clotting treatment earlier this month, were trading down about 1 percent at $8.16 Tuesday after-the-bell.
Tue, Nov 23 2010
* Says received a notice from Roche unit on Nov 19
* Roche prohibited to develop related compounds for 10 yrs
* Shares down 1 pct after-the-bell
Nov 23 (Reuters) - Ligand Pharmaceuticals Inc (LGNDD.O: Quote, Profile, Research) said Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research) was exercising its right to terminate the collaboration and license agreement between the two companies on developing hepatitis C treatment.
The collaboration and license agreement with Roche began in 2008 to develop new treatments for hepatitis C viral infection using liver-targeting technology.
In April, Ligand received $6.5 million milestone payment from Roche.
As per the agreement, Ligand will receive a non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales.
Roche will be prohibited for ten years following the termination from developing or commercializing related compounds, Ligand said in a regulatory filing.
Ligand said it received a notice from Roche units last Friday regarding the termination.
Ligand's shares, which have lost about 18 percent since the company got Japanese marketing nod for its blood clotting treatment earlier this month, were trading down about 1 percent at $8.16 Tuesday after-the-bell.
Roche severs HCV treatment collaboration and license agreement between with Ligand Pharma...
Drug giant Roche terminates it's treatment collaboration and license agreement with Ligand Pharma. Ligand gets a good deal, with non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales. Roche, on the other hand, is prohibited for ten years following the termination from developing or commercializing related compounds. Maybe the InterMune deal was enough? Nah. Has to be some other reason.
Tue, Nov 23 2010
* Says received a notice from Roche unit on Nov 19
* Roche prohibited to develop related compounds for 10 yrs
* Shares down 1 pct after-the-bell
Nov 23 (Reuters) - Ligand Pharmaceuticals Inc (LGNDD.O: Quote, Profile, Research) said Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research) was exercising its right to terminate the collaboration and license agreement between the two companies on developing hepatitis C treatment.
The collaboration and license agreement with Roche began in 2008 to develop new treatments for hepatitis C viral infection using liver-targeting technology.
In April, Ligand received $6.5 million milestone payment from Roche.
As per the agreement, Ligand will receive a non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales.
Roche will be prohibited for ten years following the termination from developing or commercializing related compounds, Ligand said in a regulatory filing.
Ligand said it received a notice from Roche units last Friday regarding the termination.
Ligand's shares, which have lost about 18 percent since the company got Japanese marketing nod for its blood clotting treatment earlier this month, were trading down about 1 percent at $8.16 Tuesday after-the-bell.
Tue, Nov 23 2010
* Says received a notice from Roche unit on Nov 19
* Roche prohibited to develop related compounds for 10 yrs
* Shares down 1 pct after-the-bell
Nov 23 (Reuters) - Ligand Pharmaceuticals Inc (LGNDD.O: Quote, Profile, Research) said Swiss drugmaker Roche Holding AG (ROG.VX: Quote, Profile, Research) was exercising its right to terminate the collaboration and license agreement between the two companies on developing hepatitis C treatment.
The collaboration and license agreement with Roche began in 2008 to develop new treatments for hepatitis C viral infection using liver-targeting technology.
In April, Ligand received $6.5 million milestone payment from Roche.
As per the agreement, Ligand will receive a non-exclusive, worldwide, royalty-bearing license under specified Roche patents to develop, make and sell related compounds and products, subject to royalty payments on net sales.
Roche will be prohibited for ten years following the termination from developing or commercializing related compounds, Ligand said in a regulatory filing.
Ligand said it received a notice from Roche units last Friday regarding the termination.
Ligand's shares, which have lost about 18 percent since the company got Japanese marketing nod for its blood clotting treatment earlier this month, were trading down about 1 percent at $8.16 Tuesday after-the-bell.
Thursday, October 7, 2010
InterMune spins of Danoprevir development and commercialization rights to Roche...
Roche Pays InterMune $175M for Rights to Danoprevir
BioWorld Today - Oct. 07, 2010
$530M Deal Axed
InterMune Inc. reported late Wednesday that it sold worldwide development and commercialization rights to danoprevir (RG7227 or ITMN-191) to partner Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd., of Basel, Switzerland, for $175 million in cash.
In connection with the transaction, the collaboration agreement that Brisbane, Calif.-based InterMune and Roche entered into in October 2006, valued at a potential $530 million, has been terminated. In addition, the companies are actively exploring ways to continue their ongoing work together on other hepatitis C virus research programs. (See BioWorld Today, Oct. 18, 2006.)
With the net proceeds from the transaction, InterMune expects to have a cash balance of about $290 million at the end of 2010.
InterMune's Dan Welch, chairman, CEO and president, said the cash infusion will allow his company to "aggressively pursue" the registration and commercialization of pirfenidone, a drug that failed to win FDA approval as a treatment for idiopathic pulmonary fibrosis despite the strong backing of an agency panel of experts. (See BioWorld Today, May 5, 2010.)
The company's stock (NASDAQ:ITMN) lost 32 cents, to close at $13.45 Wednesday, but following the late-breaking news, was up as much as 9 percent in after-hours trading.
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