From Princeton to Purdue

BASi and Pharmasset sign pact on toxicology, bioanalytical services

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PRINCETON, N.J.—An agreement to provide exclusive toxicology services, pharmaceutical analysis and bioanalytical services are at the heart of a new preferred provider pact signed by life sciences company Bioanalytical Systems (BASi) and clinical-stage pharmaceutical company Pharmasset.

According to BASi, the company has been providing Pharmasset with preclinical toxicology, pharmaceutical and bioanalytical analysis services since early 2000. The time was right, after a fruitful decade, to commit on paper to a tighter bond.

Pharmasset's main focus is the development of oral therapeutics for the treatment of the hepatitis C virus. Its secondary focus is the development of Racivir for the treatment of human immunodeficiency virus infection. The company's current and ongoing 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.

"BASi provides world-class research to the pharmaceutical and biotech industries," says Philip A. Downing, assistant general manager and director of analytical services for BASi. "We were established in 1974, and offer an extensive array of contract laboratory services including preclinical toxicology, bioanalysis and a full range of pharma analysis services. We also manufacture more than 30 different scientific instruments including the novel Culex Automated In-Vivo Sampling System, which can collect blood, bile, metabolites and dialysates from awake and freely moving laboratory animals."

BASi currently is a presence throughout the world, and hopes this deal will help the company enhance its presence in Europe and Asia.

As part of this partnership, BASi will provide early discovery and pre-investigational new drug (IND) application enabling services, including acute and subchronic studies with pharmaceutical, bioanalytical and toxicokinetic analysis, as well as the post-IND studies, such as chronic, carcinogenicity and reproductive toxicology, required for new drug applications, adds Downing.

"The agreement between Pharmasset and BASi is an important strategy and commitment for both companies, commented BASi president and CEO Anthony Chilton in a prepared statement. "It represents a significant step in BASi's strategy to work closely with our partners in the pharmaceutical industry."

Downing says that his company's array of innovative services will enhance Pharmasset's efficiency, and lower costs inherent in bringing new drugs to market.

"BASi prides itself in having many long-term clients who have honored us with repeat business," explains Downing. "Success for BASi will be maintaining those relationships and offering new clients the opportunity to experience the quality and timely service getting their products to market."

Pharmasset officials deferred to BASi to answer ddn's questions for this story. Company officials would not disclose specifics such as an end date to the agreement or agreed-upon benchmarks.

BASi provides contract research services and research instruments and supplies to the world's leading drug development companies and medical research organizations.

Pharmasset also recently announced a public offering of 3 million shares of its common stock pursuant to an effective shelf registration statement. Of the shares being sold, Pharmasset is selling 2 million shares, and the selling stockholders are selling 1 million shares.

Pharmasset partners with BMS in hepatitis C deal

PRINCETON, N.J.—Pharmasset also recently entered into a clinical collaboration agreement with Bristol-Myers Squibb Co. (BMS) to evaluate the utility of BMS-790052, BMS' NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset's nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus (HCV).

This proof-of-concept study will evaluate the potential to achieve sustained viral response 24 weeks post treatment with an oral, once-daily treatment regimen in patients across HCV genotypes. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of BMS-790052 in combination with PSI-7977, with and without ribavirin, in treatment-naÔve patients chronically infected with HCV genotypes 1, 2 and 3. The study is planned to start in the first half of 2011.

According to the companies, the collaboration represents the first cross-company collaboration combining two oral agents to address a significant unmet medical need in the treatment of HCV.

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