Biotech Values

[DewDiligence]

GILD’s Viread works in HBV: i.e. it is at least as
good as, and probably better than, its close cousin,
Hepsera. These are the results of the first of two
phase-3 trials for Viread in HBV; the second trial
will report later this year.

Most knowledgeable observers in the HBV arena
expected Viread to work in HBV because Hepsera,
which is approved for HBV, is essentially “Viread
Lite.” What this means from a business standpoint,
IMO, is that Viread will capture market share from
Hepsera but will have little if any effect on the
sales of Baraclude and Tyzeka. Note that Viread
and Hepsera are nucleotide analogues while
Baraclude and Tyzeka are nucleoside analogues.
The most effective treatment regimen for chronic
HBV is likely to be a combination of a nucleoside
and a nucleotide.

http://biz.yahoo.com/bw/070606/20070606006193.html?.v=1

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Phase III Study Evaluating Gilead's Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint

Wednesday June 6, 5:35 pm ET

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD ) today announced that Study 102, a Phase III clinical trial evaluating the company's once-daily anti-HIV drug Viread® (tenofovir disoproxil fumarate or tenofovir DF) 300 mg as a potential treatment for chronic hepatitis B virus (HBV) infection, met its primary efficacy endpoint. The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera® (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two point reduction in the Knodell necroinflammatory score (a measure of necro-inflammation - an inflammatory process in the liver including or leading to death of liver cells) with no concurrent worsening of fibrosis (scarring of liver tissue).

At 48 weeks, 70.8 percent of patients in the Viread arm (n=250) had a complete response compared to 48.8 percent in the Hepsera arm (n=125; p less than 0.001). The most commonly observed treatment-emergent adverse events of moderate intensity or higher were abdominal pain, back pain, headache, respiratory infections, creatinine phosphokinase and transaminase elevations. The incidence of these events was comparable between the Viread and Hepsera arms of the study. In addition, the incidence of grade 3 or 4 laboratory abnormalities was comparable between the two arms. Full study results will be submitted for presentation at an upcoming scientific meeting [probably AASLD in November].

"Chronic hepatitis B remains a serious disease that impacts more than one million people in the United States and an estimated 400 million people worldwide," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We believe Viread has the potential to be an important treatment option for patients with chronic hepatitis B and look forward to sharing detailed data from this study at a scientific conference later this year."

Study 102 is one of two Phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B. The second study (Study 103), a 48-week trial among patients with hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B, is expected to be complete later this year.

The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.

Study Design

Study 102 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48-weeks among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B. Three hundred and seventy-five patients were randomized in a 2:1 ratio to receive either tenofovir DF (300 mg once daily; n=250) or Hepsera (10 mg once daily; n=125).
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