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Senate HELP Panel Begins Mark Up Of Bill Placing Tobacco Under FDA Oversight
The Senate Health, Education, Labor and Pensions Committee on Tuesday began marking up a bill (S 982) that would allow FDA to regulate tobacco products, CongressDaily reports. The bill would allow FDA to place larger, color warning labels about the health risks of smoking on cigarette packs, as well as to regulate the marketing of tobacco products and advertising to children. The agency could not ban tobacco products or eliminate nicotine from cigarettes, but it could regulate their production and ban flavored cigarettes other than menthol. Sen. Chris Dodd (D-Conn.) said, "Over the years, this bill has been reviewed; it has been vetted; it has been debated, over and over and over again. The time has come to act." The House in April passed its version of the bill, 298-112 (Hunt, CongressDaily, 5/20). The committee by voice vote approved an amendment proposed by Sen. Jeff Merkley (D-Ore.) that would give FDA priority to review products that contain nicotine, such as candies. Committee ranking member Mike Enzi (R-Wyo.) proposed two amendments, one that would have given regulatory authority over tobacco to CDC and another that would have ordered FDA to study which flavors to ban, instead of a current provision that bans specific flavors. Both amendments were defeated. Enzi said, "I think the FDA is the wrong regulator. It approves cures, not poisons." The only Democrat who opposed the bill was Sen. Kay Hagan (N.C.), who said the measure would harm the tobacco industry in her home state (Armstrong, CQ HealthBeat, 5/19). The panel"s other member from North Carolina, Sen. Richard Burr (R), said he would filibuster the bill. He said, "I put my fellow senators on notice: This is something that will be a much longer time on the floor than it will be in this hearing" (CongressDaily, 5/20). The committee plans to continue marking up the bill Wednesday and possibly Thursday.The Obama administration has expressed its support for the bill (CQ HealthBeat, 5/19). FDA Commissioner Margaret Hamburg also has said her agency should regulate tobacco (Armstrong, CQ HealthBeat, 5/18).
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Financial Secretary Contacts UK Autism Foundation On Autism And The Economic Downturn
The Financial Secretary to Her Majesty"s Government, Rt. Hon. Stephen Timms MP has written to Ivan Corea of the UK Autism Foundation, pledging support for families with autism.
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Medical Device Development: Stanford Researchers Publish Comprehensive Model
In an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, researchers at Stanford University have published the first comprehensive model representing the medical device development process.
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Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial Of PSI-7851 In Chronic Hepatitis C Patients

Pharmasset, Inc. (Nasdaq: VRUS) announced that it had completed the single ascending dose study and begun dosing in a multiple ascending dose trial with PSI-7851, a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. This study is designed to assess the safety, tolerability and antiviral activity of PSI-7851 over 3 days in HCV-infected individuals. "We are encouraged by the safety and pharmacokinetics of PSI-7851 thus far," stated Michelle Berrey, MD, MPH, Pharmasset"s Chief Medical Officer. "We believe PSI-7851, Pharmasset"s lead second generation nucleotide, has the potential to be administered once a day at low milligram doses, while also continuing to demonstrate the many benefits nucleos(t)ides have over other classes of HCV direct acting antivirals, including a high barrier to resistance, pan-genotype potency, and ability to combine with other classes of compounds." PSI-7851 Phase 1 Program Overview The Phase 1 program is investigating the safety, tolerability and pharmacokinetics of PSI-7851 in healthy subjects following single doses (Phase 1a) and in patients chronically infected with HCV genotype 1 following repeat dosing for 3 days (Phase 1b). The Phase 1b study will additionally investigate hepatitis C viral dynamics and monitor for the development of drug resistance. Subjects in the phase 1a single ascending dose study received single doses of PSI-7851 ranging from 25mg to 800mg or a matching placebo. Preliminary data from the phase 1a single ascending dose study demonstrated: -- No serious adverse events or discontinuations; -- No dose-related adverse events; -- No grade III / IV lab abnormalities; -- No clinically significant changes in vital signs or ECGs. A Phase 1b multiple ascending dose trial has now been initiated in patients with chronic HCV genotype 1 infection. Subjects will be enrolled at multiple centers and randomized to PSI-7851 (8 per cohort) or placebo (2 per cohort). Based upon the results from the SAD study, the first dose of PSI-7851 to be tested will be 50mg once daily. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-7851 after repeat dosing over 3 days. The secondary objective is to evaluate the decrease in HCV RNA. Results from both studies are expected in the second half of 2009. About PSI-7851 PSI-7851 is a uridine nucleotide analog currently in development for the treatment of chronic HCV infection. PSI-7851 has demonstrated potent in vitro anti-HCV activity with EC50 values of 90 +/- 60 nM, which is approximately 15- to 20-fold more potent than Pharmasset"s first generation nucleoside polymerase inhibitor, R7128. In vitro studies of PSI-7851 have not shown evidence of any mitochondrial or other cellular toxicities that may be associated with some nucleoside analogs. The half-life of the triphosphate in primary human hepatocytes is approximately 38 hours, which suggests the possibility for once-daily dosing. Like R7128, PSI-7851 has demonstrated in vitro activity against all of the most common HCV genotypes. 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(R) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleos(t)ide analogs, a class of compounds which act to inhibit the enzymes required for viral replication. We currently have three clinical-stage product candidates: R7128, a nucleoside analog for chronic HCV infections, has initiated a Phase 2b clinical trial in combination with Pegasys plus Copegus through a strategic collaboration with Roche; PSI-7851, an unpartnered, next generation HCV nucleotide analog, which recently began Phase 1 clinical studies and Racivir, for the treatment of HIV that has completed a Phase 2 clinical trial. Pegasys(R) and Copegus(R) are registered trademarks of Roche. 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 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 the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, 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, 2008 and our Quarterly Report on Form 10-Q for the period ended March 31, 2009 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. Pharmasset, Inc


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