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Roche Begins Phase-2 for HCV Polymerase Inhibitor

[Roche’s R1626 is the most direct competitor to NM283 from IDIX and NVS. It has a similar MoA to NM283 but it is given twice daily while NM283 is given once daily. This phase-2 trial will test R1626 at low and high doses with peg-interferon (Pegasys) and, at the low dose only, with both peg-interferon and ribavirin (Copegus). R1626 treatment lasts four weeks and is followed by 44 weeks of SoC. The short duration of R1626 treatment makes this trial more of a phase-2a in character than a full-fledged phase-2. The number of patients is not specified in this PR, but all patients will be treatment-naïve genotype-1.]

http://biz.yahoo.com/bw/061013/20061012005872.html?.v=1

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Roche Advances Oral Polymerase Inhibitor into Phase II Study in Patients with Chronic Hepatitis C

Friday October 13, 2:00 am ET

FDA Grants Fast Track Status To R1626

NUTLEY, N.J.--(BUSINESS WIRE)--Roche today announced the initiation of the first Phase II study to evaluate R1626, an investigational polymerase inhibitor, for the treatment of chronic hepatitis C. The drug has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), a program designed to facilitate the development and to expedite the review of new drugs with the potential to help treat serious or life-threatening conditions.

R1626, which has been shown to have a strong antiviral effect, uses a different mechanism of action from the current standard HCV treatment. In a Phase I study, the drug achieved significant reductions in viral levels in chronic hepatitis C patients infected with genotype 1, the most difficult to treat form of the virus. While patients with genotype 1 virus in clinical trials with Roche's currently-available hepatitis C therapies, PEGASYS® (peginterferon alfa-2a) and COPEGUS (ribavirin), had an approximate 50 percent chance of achieving a sustained virologic response (SVR), a strong medical need remains for new therapies to improve these response rates.

By moving R1626 into its first Phase II trial, Roche signifies its commitment to improving therapeutic options for patients with hepatitis C. The trial will evaluate the safety and antiviral effect of R1626 in combination with PEGASYS and COPEGUS.

"New medicines such as R1626 have strong antiviral activity and the potential to help more patients achieve treatment success, especially when used in combination with current treatments," said Dr. Paul Pockros, Head of the Division of Gastroenterology/Hepatology at The Scripps Clinic in San Diego and principle investigator of the study. "A product that could potentially improve treatment success rates, particularly for the hardest-to-treat forms of the virus, is much needed."

About the Phase II Study

The study announced today is an on-going multicenter Phase II trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment. Patients are randomized into four treatment groups:

• Group A: R1626 1500mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week for 4 weeks
• Group B: R1626 3000mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week for 4 weeks
• Group C: R1626 1500mg twice a day + PEGASYS 180mcg as a subcutaneous injection every week + COPEGUS 1000-1200mg daily for 4 weeks
• Group D: PEGASYS 180mcg as a subcutaneous injection every week + COPEGUS 1000-1200mg daily (standard of care group) for 4 weeks

Following the first four weeks of treatment, all patients will receive PEGASYS 180mcg subcutaneously every week with COPEGUS 1000-1200mg daily for another 44 weeks, for a total treatment duration of 48 weeks. The objectives of the study are to evaluate the four-week safety and antiviral effect of combining R1626 with PEGASYS and/or COPEGUS.

The study is currently enrolling patients in the U.S. Patients and healthcare providers interested in the trial can find more information at www.roche-trials.com.

…About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
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