Biotech Values

[DewDiligence]

Europe’s CHMP Approves Viread for HBV

[There was never any real doubt about approval of Viread for HBV inasmuch as the phase-3 data are superb (#msg-24255644) and Viread has been marketed for years in HIV at the same dose, so there’s a huge safety database to draw on. Formal EU approval for marketing should come in 2-3 months. (The FDA PDUFA date on the Viread NDA is 8/11/08 because, unlike the EMEA, the FDA did not grant a priority review.)

Once Viread is launched for HBV, GILD will cease promoting Hepsera and Viread should garner all of Hepsera’s market share, and more, in due course.]

http://biz.yahoo.com/bw/080319/20080319006160.html

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European CHMP Issues Positive Opinion for Viread® for the Treatment of Chronic Hepatitis B

Wednesday March 19, 4:01 pm ET

Milestone in the Development of Potential New Treatment for Life-Threatening Disease

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on the company’s application to extend the indication for Viread® (tenofovir disoproxil fumarate) to include the treatment of chronic hepatitis B in adults. The application, known as a Type II variation, was submitted to European regulatory authorities in October 2007.

The CHMP’s positive opinion will be forwarded to the European Commission, which will amend the Marketing Authorisation for Viread in the 27 countries of the European Union to reflect the Type II variation. The European Commission generally issues an updated Marketing Authorisation within a few months following a positive CHMP recommendation. Viread represents Gilead’s second once-daily antiviral developed for the potential treatment of chronic hepatitis B. The active ingredient in Viread, tenofovir disoproxil fumarate, is the most widely prescribed molecule for the treatment of HIV infection in the United States and several countries of the EU.

“The complications associated with chronic hepatitis B make it a leading cause of death worldwide,” said Patrick Marcellin, MD, Hôpital Beaujon, Clichy, France. “In Europe, the incidence of chronic hepatitis B is significant and growing, which underscores the importance of increased screening and immunization for eligible patients, and the need for safe and effective treatment options that can slow or potentially even halt the progression of liver damage for patients living with chronic hepatitis B.”

The application is based primarily on data from two ongoing Phase III clinical trials, Studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the efficacy, safety and tolerability of Viread compared to adefovir dipivoxil. Positive data from both studies were described in late-breaker presentations at the annual meeting of the American Association for the Study of Liver Diseases in November 2007. Additional 72-week data from these studies will be presented at the annual meeting of the European Association for the Study of the Liver (EASL), taking place in Milan, Italy, April 23-27.

Gilead has also submitted applications for marketing approval of Viread for hepatitis B in the United States, Australia, Canada, New Zealand and Turkey.
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