Merck and Roche to Collaborate on Combination Regimens for Hepatitis C

Merck this week announced a collaboration with Roche to evaluate combination regimens for chronic hepatitis C virus (HCV) infection containing Merck's approved HCV protease inhibitor boceprevir (Victrelis) and Roche's experimental HCV polymerase inhibitor mericitabine (formerly RO5024048 and RG7128).

The international Phase 2 DYNAMO trial will test the oral drugs plus pegylated interferon/ribavirin in difficult-to-treat prior null responders with HCV genotype 1.

Below is an edited excerpt from a Merck press release describing the collaboration and forthcoming studies.

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 Sstation, N.J. -- December 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, MD, 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.

The full release, including important safety information about Victrelis, is available at http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_1215.html

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.

12/16/11

Source

Merck. Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection. Press release. December 15, 2011.