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Replies to #68043 on Biotech Values
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Biowatch

11/01/08 6:51 PM

#68097 RE: DewDiligence #68043

Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread(R) for Chronic Hepatitis B
Saturday November 1, 11:00 am ET
- No Resistance Observed Through Two Years of Treatment -
- Significant Viral Suppression Seen in Patients Switching to Viread -


SAN FRANCISCO--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD - News) today announced the presentation of two-year (96-week) data from two Phase III pivotal clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection. These data will be presented during oral sessions at the annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2008) being held this week in San Francisco (October 31-November 4).

Studies 102 and 103 will evaluate treatment with Viread for up to eight years among patients with HBeAg-negative and HBeAg-positive chronic hepatitis B, respectively, with compensated liver disease. Patients in both studies were originally randomized to receive Viread or Hepsera® (adefovir dipivoxil). After the completion of 48 weeks of randomized blinded therapy, all eligible patients were rolled over to open-label Viread monotherapy.

etc....
http://biz.yahoo.com/bw/081101/20081101005012.html?.v=1
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DewDiligence

01/27/09 8:43 AM

#72276 RE: DewDiligence #68043

Baraclude sales ramp and HBV market:

Almost four years after reaching the market, Baraclude sales have reached an impressive annualized rate of $620M, but growth has slowed to a trickle. The cause of the plateau is almost certainly the approval and launch of Viread for HBV in August 2008.

Baraclude’s sales were painfully slow at the outset because existing HBV patients do not switch meds unless they suffer a viral breakthrough, but they picked up nicely during the third year on the market.

4th year—first 9 months: $435M ($620M run rate in 4Q08)
3rd full year (Apr07-Mar08): $348M
2nd full year (Apr06-Mar07): $117M*
1st full year- (Apr05-Mar06): $23M

*Added to AASLD guidelines Feb 2007;
Japan, EU launches Jul 2006.