Replies to post #90747 on Biotech Values

[mcbio]

VRUS - Additional RG7128 Data/PSI-7977

http://finance.yahoo.com/news/Pharmasset-to-Present-New-prnews-1705789415.html?x=0&.v=1

Pharmasset to Present New Data on RG7128 and PSI-7977 at the EASL Conference
-- Follow up data from a 28 day trial with RG7128 and standard of care demonstrated an SVR of 65% in HCV genotype 2/3 prior non-responders
-- In vitro results demonstrate that a combination of two nucleotide analogs, PSI-7977 and PSI-938, are able to suppress S282T-resistant replicons

PRINCETON, N.J., April 13 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces the oral presentation of new sustained virologic response (SVR) follow-up data in hepatitis C virus (HCV) genotype 2 and 3 non-responder patients treated for 28 days with RG7128 in combination with the standard of care (SOC), Pegasys® and Copegus®, and presentation of an in vitro combination study with PSI-7977 and PSI-938. Both presentations are at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria (April 14-18, 2010).

On April 15, Edward Gane, M.D., Associate Professor, University of Auckland, and Director, Auckland Clinical Studies Limited, will give an oral presentation entitled "Sustained virologic response (SVR) following RG7128 1500mg BID/PegIFN/RBV for 28 days in HCV Genotype 2/3 prior non-responders" at 5 PM CEST during the hepatitis C drug development session. Data from this trial suggest that the nucleoside RG7128 in combination with SOC is effective in retreatment of HCV genotype 2/3 relapsers/nonresponders and may provide an attractive option for treatment of prior non-responders and treatment-naive patients with HCV genotype 2/3. Larger studies are required to confirm these findings, determine the optimal duration of RG7128 therapy, and evaluate utility in treatment-naive genotype 2/3 patients.

On April 17, Dr Veronique Zennou, a Pharmasset scientist, will present a poster entitled "Combination of two complementary nucleotide analogues PSI-7977 and PSI-938 effectively clears wild type and NS5B S282T HCV replicons – comparison with combinations of other antiviral compounds" (Poster 1034). The data indicate that in vitro combinations of two nucleotides targeting NS5b effectively suppress resistant replicons with no emergence of resistance. The poster will include comparative data on combinations of other direct acting antivirals (DAA) targeting different HCV proteins.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates. RG7128, a nucleoside analog for chronic HCV infection, is in two Phase 2b clinical trials in combination with Pegasys® and Copegus® and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys® and Copegus® to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical stage candidates include PSI-7977, an unpartnered, next- generation HCV nucleotide analog that is in a Phase 2a trial; PSI-938 in Phase 1a and Racivir, for the treatment of HIV, which has completed a Phase 2 clinical trial. We also have in our pipeline an additional purine nucleotide analog, PSI-661, an isomer of PSI-879, in advanced preclinical development.

Pegasys® and Copegus® are registered trademarks of Roche.

[DewDiligence]

VRUS/Roche: Hmm…notably absent from the section of yesterday’s VRUS’ PR that enumerates 2010 clinical news (#msg-53137438) is any mention of a phase-2b trial of RG7128 + SoC in genotype-2/3 patients. This is curious insofar as VRUS’ PR from Feb 2010 (#msg-46762882) said:

Roche is planning to initiate a Phase 2b study of RG7128 in combination with pegylated interferon and ribavirin in patients with HCV genotypes 2 and 3 later in 2010.

A reasonable inference is that this phase-2b trial is no longer planned. If this is in fact the case, the decision by Roche not to run such a study makes perfect sense, IMO.