Replies to post #77776 on Biotech Values

[mcbio]

Re: VRUS (R7128 pre-clinical kidney tox)

As I've mentioned before, I'm taking a much closer look at VRUS and may establish a position (actually may swap ACHN for VRUS entirely now) once the initial Phase 2b safety data for R7128 is out on the first 100 patients in 2H 09. I think this event will reduce, though perhaps not yet eliminate, some of the kidney tox concerns that were evident in pre-clinical tox studies in monkeys.

I'm just curious, though, do we know what the dose was that showed kidney tox in monkeys? I know the dose was much higher than the dose in humans but am curious if we know the exact number. And how long did it take before the tox appeared? I believe the interim Phase 2b safety look will be after 12 weeks.

Regardless, I assume pretty much any drug is going to show toxicity if you dose it high enough and for an extended timeframe so perhaps any fears of kidney tox from R7128 treatment are overblown. This may be particulary true if the kidney tox in monkeys occurred at both a much higher dose and for a much longer duration of treatment than that being tested in humans.

[DewDiligence]

VRUS Reports FY3Q09 Results

[VRUS’ fiscal year ends on Sep 30. No new info here other than the cash balance and the cash burn in the latest quarter. Please see actual PR for financial tables.]

http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=402552

›PRINCETON, N.J., Aug 10, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal quarter ended June 30, 2009.

Financial Results

Revenues were $10.5 million during the quarter ended June 30, 2009 compared to $0.5 million for the quarter ended June 30, 2008 and reflect the receipt of a $10.0 million milestone payment from Roche, following the initiation of the phase 2b study with RG7128, and the amortization of up-front and subsequent collaborative and license payments received from Roche.

Net cash used in operating activities was $5.8 million for the quarter ended June 30, 2009 as compared to $12.7 million for the quarter ended June 30, 2008. Pharmasset held $72.7 million in cash and cash equivalents at the end of the fiscal third quarter.

Total operating expenses for the quarter ended June 30, 2009 were $16.7 million as compared to $15.0 million for the same period in 2008. The increase in operating expenses for the quarter ended June 30, 2009 was primarily the result of an increase in clinical development expenses for PSI-7851, our second generation hepatitis C virus (HCV) product candidate, and preclinical development expenses for our purine series of compounds. Partially offsetting these increases were reduced expenses for our clevudine Phase 3 registration studies that were terminated during the quarter.

Pharmasset reported a net loss of $6.9 million, or $0.25 per share, for the quarter ended June 30, 2009, as compared to a net loss of $15.0 million, or $0.69 per share, for the quarter ended June 30, 2008.

Recent Highlights:

-- On July 31, 2009, Pharmasset announced positive preliminary results from a 3 day, multiple ascending dose trial with PSI-7851, a second generation, nucleotide analog inhibitor in HCV patients;

-- On July 7, 2009, Pharmasset announced the nomination of PSI-938 as a development candidate from two series of purine analogs for the treatment of chronic HCV infection. PSI-938 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug (IND) application with the FDA or equivalent foreign regulatory application;

-- On June 9, 2009, Pharmasset announced that it had completed a single ascending dose trial with PSI-7851 and had begun dosing in a 3 day, multiple ascending dose trial in hepatitis C infected patients;

-- On April 25, 2009, Pharmasset announced positive results from the INFORM-1 study of the combination of RG7128 and another oral antiviral medicine, in the absence of interferon and ribavirin, for the treatment of HCV patients; and

-- In the third quarter, Pharmasset received a $10 million milestone from Roche following the initiation of the Phase 2b trial with RG7128, a first generation nucleoside prodrug for the treatment of hepatitis C.

"Pharmasset had another productive quarter, as we continued to make progress on all three of the nucleoside/tide analogs comprising our current portfolio of HCV product candidates", stated Schaefer Price, President and Chief Executive Officer. "We believe HCV therapy is evolving toward combinations of oral antiviral drugs. While we believe combinations of a nucleoside/tide with a drug having a different mechanism of action are very promising, we also believe combinations of two complementary nucleoside/tides have the potential for both a superior resistance profile and activity across all genotypes based on the in vitro evidence to date."

Calendar Year 2009 Anticipated Milestones:

-- Provide an update on safety from the first 100 patients in the Phase 2b trial of RG7128 in second half of 2009;

-- Report additional phase 1 antiviral data with PSI-7851 in second half of 2009;

-- Report further data from the INFORM-1 trial in fourth quarter of 2009.

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 infections, is in a Phase 2b clinical trial in combination with Pegasys plus Copegus and is also in INFORM-1 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 are PSI-7851, an unpartnered next generation HCV nucleotide analog which recently began Phase 1 clinical studies, and Racivir, for the treatment of HIV, which has completed a Phase 2 clinical trial.‹