Navigation Links
Pharmasset Receives Notice of Allowance

-USPTO to grant patent covering the anti-HCV drug PSI-6130 and its active


PRINCETON, N.J., June 26 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced that the United States Patent and Trademark Office has issued a Notice of Allowance for patent application Serial No. 10/828,753 titled, "Modified Fluorinated Nucleoside Analogues," covering the composition of matter of a family of molecules invented at Pharmasset for the treatment of hepatitis C virus (HCV), including PSI-6130 and the active metabolite of PSI-7851. R7128, a prodrug of PSI-6130, a nucleoside analogue polymerase inhibitor of HCV, is being developed through Pharmasset's collaboration with Roche. PSI-7851 is a proprietary nucleotide analogue polymerase inhibitor of HCV that Pharmasset has nominated as a lead development candidate.

"We are pleased that the USPTO has recognized our intellectual property rights in our growing pipeline of HCV nucleoside polymerase inhibitors," stated Schaefer Price, Pharmasset's Chief Executive Officer. "The success that our in-house research team has had in discovering new HCV product candidates can now be translated into potentially significant commercial value."

About R7128

R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. Results from an oral single ascending dose study of PSI-6130 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 demonstrated potent, dose-dependent antiviral activity across four prior treatment-failure patient cohorts (n=40) receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in the study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of the development of viral resistance in any dose cohort after 14 days of dosing.

In a 4-week Phase 1 combination study that was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated potent short-term antiviral activity and was generally safe and well tolerated. Eighty-five percent (85%) of patients receiving R7128 1500mg twice-daily (BID) with Pegasys plus Copegus for 4 weeks achieved undetectable HCV RNA levels with safety and tolerability comparable to placebo with Pegasys plus Copegus.

We have commenced dosing two additional cohorts of this 4-week Phase 1 study. Cohort 3 will continue dose-exploration with administration of R7128 1000mg twice-daily (BID) with Pegasys plus Copegus in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg BID with Pegasys plus Copegus in treatment-experienced patients with genotypes 2 or 3 who did not achieve a sustained virologic response (SVR) with previous interferon-based therapy.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.

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 B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys(R) plus Copegus(R) through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.

Pegasys(R) and Copegus(R) are registered trademarks of Roche.


Kurt Leutzinger

Chief Financial Officer

Office: +1 (609) 613-4110

Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that the USPTO will withdraw the Notice of Allowance, adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that we cannot enroll enough patients for the Phase 3 registration clinical trial for clevudine, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.

SOURCE Pharmasset, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers
2. Pharmasset Commences Dosing in Phase 3 Registration Studies of Clevudine for HBV
3. Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C
4. Pharmasset Announces Clevudine and R7128 Presentations at HEP-DART
5. Pharmasset Announces R7128 Achieves 85% Rapid Virologic Response in a 4-week Combination Study for the Treatment of Chronic Hepatitis C
6. Roche and Pharmasset To Present the R7128 Monotherapy Resistance Profile
7. Pharmasset Reports First Fiscal Quarter 2008 Financial Results
8. Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
9. Pharmasset Commences Dosing R7128 Cohorts 3 and 4 for the Treatment of Chronic Hepatitis C
10. Pharmasset Nominates PSI-7851 as a Lead Development Candidate for the Treatment of Chronic Hepatitis C
11. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
Post Your Comments:
(Date:11/24/2015)... -- Sectra (STO: SECT B) announces that ... multi-year agreement to deploy Breast Imaging PACS in ... the Breast Center a future-proof platform capable of expanding with ... announces that Breast Center of Acadiana has entered ... PACS in its two freestanding imaging centers. This investment will ...
(Date:11/24/2015)... , November 24, 2015 ... --> adds Latest Guidebook for Chinese ... 217 pages published in November 2015 to the ... business intelligence library at . ... the fastest growing global economies with a fifth ...
(Date:11/24/2015)... F1000Workspace - a research collaboration, ... was launched just six months ago. --> F1000Workspace ... for scientists - since it was launched just six months ... on to F1000Workspace - a research collaboration, reference ... launched just six months ago. --> ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a ... sleep tracking systems. The new app features a more intuitive SleepScore™ that rates sleep ... well you slept. The SleepScore is created by a proprietary algorithm. Beddit analyzes the ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, ... from Bronx, N.Y. “I thought there had to be a convenient and comfortable way ... , The PROTECTOR enables disabled individuals to safely travel during cold or inclement weather. ...
(Date:11/25/2015)... Md (PRWEB) , ... November 25, 2015 , ... ... Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible for ... of this disease. The Periwinkle Pioneers, nominated by the public, will receive special ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely ... resulting in a way for homeless people to have a more dignified and ... new initiative whereby they are repurposing plastic bags into sleeping mats for the ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... on providing comprehensive solutions involving adult stem cell therapies to patients with chronic ... the “Regenestem” name as a Registered Trademark (RTM). , Organizations are required to ...
Breaking Medicine News(10 mins):