Replies to post #36370 on Biotech Values

[DewDiligence]

Pharmasset Initiates Phase-1 Study of R7128 for HCV

[This very early HCV program is partnered with Roche. The new drug candidate, R7128, is a prodrug of a polymerase inhibitor that was previously tested in a phase-1 study. This drug should not be confused with Roche’s in-house HCV polymerase inhibitor, R1676, which is now entering phase-2.]

http://biz.yahoo.com/prnews/061027/nyf043.html?.v=70

>>
Friday October 27, 7:00 am ET

PRINCETON, N.J., Oct. 27 /PRNewswire/ -- Pharmasset provided an update today on their collaboration with Roche to develop nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus (HCV) infections. Pharmasset initiated oral dosing of R7128 in a Phase 1 clinical trial being conducted under a U.S. FDA Investigational New Drug application. This study is designed to assess the safety and pharmacokinetics of R7128 in healthy volunteers, as well as provide antiviral potency data over 14-days in HCV- infected individuals.

…About R7128

R7128 is a polymerase inhibitor being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated excellent potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.

R7128 Phase 1 Study Overview

The Phase I clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients with chronic HCV genotype 1 infection. This study will be comprised of two parts:

-- Part 1 is a single ascending dose study being conducted in up to 38 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 in healthy volunteers following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128.

-- Part 2 is a multiple ascending dose study being conducted in up to 48 patients infected with HCV genotype 1. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 in HCV genotype 1-infected patients after once-daily or twice-daily dosing for 14 days. The secondary objective is to evaluate the decrease in HCV viral load.

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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). For more information, please visit http://www.pharmasset.com.
<<

[DewDiligence]

Re: Preliminary Clevudine phase-3 results

I’ve reformatted the tables in the
PR for better comprehension:

% e-positive patients 
 w HBV DNA<300 copies/ml 
   
 Wk-24  Wk-48  Wk-60 
  53%    68%    31% 
   
 % e-negative patients 
 w HBV DNA<300 copies/ml 
   
 Wk-24  Wk-48  Wk-60 
 100%   100%    92%

Back to the Pharmasset PR:

>To our knowledge, Clevudine is the only HBV therapeutic agent, investigational or approved, that has demonstrated potentially clinically meaningful SVR levels at 12 weeks and 24 weeks post-treatment.<

Note how they use the waffle word “potentially” in this context. I would certainly object to calling these results SVR’s because I do not see where Pharmasset has established that relapses are no longer occurring, particularly in the e-negative group where relapses have been extremely common with other antiviral agents.

Also, one has to wonder if the patients selected for this preliminary analysis have been cherry picked from what is a large phase-3 trial.

Clevudine is a drug to watch, but this PR strikes me as hyped. JMHO, FWIW

[DewDiligence]

Pharmasset is attempting to resuscitate an IPO
that withdrawn in 2006. They have a phase-3 drug
(Clevudine) for HBV and a phase-1drug (R7128)
for HCV. Their Nasdaq ticker symbol, should the
IPO go off, will be the catchy “VRUS.”

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070322:MTFH67693_2...

>>
Pharmasset Readies IPO of 6M Shares @$12-$14

Thu Mar 22, 2007 5:47 PM ET

WASHINGTON, March 22 (Reuters) - Pharmasset Inc. on Thursday said it is planning 6 million shares for between $12 and $14 per share in an initial public offering.

The clinical-stage pharmaceutical company, which is focused on treating viral infections, said the underwriters will have the option to buy another $900,000 more shares to cover over-allotments.

Banc of America Securities LLC, UBS Investment Bank and JMP Securities will underwrite the IPO, according to an offering document filed with the U.S. Securities and Exchange Commission.

It is seeking a Nasdaq listing under the symbol VRUS .
<<

[DewDiligence]

Pharmasset IPO’s at Low End of Range ($9/sh)

[This was the company’s second IPO attempt; in 2006, a planned IPO at $12-14 was canceled. Pharmasset has a phase-3 drug (Clevudine) for HBV and a phase-1drug (R7128) for HCV. The Nasdaq ticker is the ultra-catchy “VRUS.”]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070426:MTFH15627_2...

>>
Thu Apr 26, 2007 7:09 PM ET

NEW YORK, April 25 (Reuters) - Pharmaceutical company Pharmasset Inc. on Thursday raised $45 million with an initial public offering that was priced at the bottom of a lowered forecast range.

The offering of 5 million shares, decreased from 6 million, sold for $9 per share, compared with a forecast range of $9 to $11, which had been lowered from a range of $12 to $14, according to an underwriter. The offering price gives the company an initial market capitalization of $194 million.

Based in Princeton, New Jersey, the company plans to use net proceeds from the offering, which represents a 23 percent stake in the company, for Phase 3 clinical trials.

Pharmasset focuses on medications to treat viral infections, including the viruses hepatitis B, hepatitis C and human immunodeficiency.

Led by Banc of America Securities LLC and UBS Securities, underwriters have the option to buy another 750,000 shares to cover overallotments, according to an underwriter.

The company applied to list its shares on the Nasdaq under the symbol VRUS .
<<