BMS licences phase II HIV compound festinavir

pharmafile | December 22, 2010 | News story | Research and Development BMS, Bristol-Myers Squibb, HIV, NRTI, Oncolys BioPharma, festinavir, nucleoside reverse transcriptase inhibitor 

Bristol-Myers Squibb is to pay hundreds of millions of dollars to a Japanese biotech firm to get its hands on an investigational HIV compound.

The US company will have exclusive global rights to manufacture, develop and commercialise festinavir, a once-a-day, oral nucleoside reverse transcriptase inhibitor (NRTI) in phase II development.

“The profile of festinavir offers the possibility of improvement in the safety of long-term HIV treatment, an area of significant unmet medical need,” explains Brian Daniels, senior vice president, development at BMS.

It was licensed to Tokyo-based Oncolys BioPharma in 2006 from Yale University. Oncolys now stands to receive up to $286 million in upfront and milestone payments, plus potential royalties on worldwide sales.

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The company, which specialises in infectious diseases and oncology, began a phase Ib clinical trial for the drug in France in early 2009 and says festinavir could offer improved safety versus previous generations of NRTIs.

“I’m convinced that festinavir has the possibility to be a potent and effective NRTI with a promising resistance profile,” says Oncolys chief executive Yasuo Urata. “Also festinavir’s once-daily dosage is essential for treating HIV patients worldwide.”  

It filed an investigational new drug application for festinavir with the FDA in March 2008. As a class, NRTIs are already well-established in HIV treatment.

For example, half of the drugs in development by specialist HIV company ViiV Healthcare, set up a year ago by GlaxoSmithKline and Pfizer, are NRTIs, including Combivir, Epivir/3TC, Epzicom/Kivexa, Retrovir/AZT, Trizivir and Ziagen.

Oncolys makes no secret of its desire for partnerships. Its antiviral pipeline includes a new class of anti-hepatitic-C-virus agents, which the company has linked up with Pfizer and Tacere Therapeutics to develop.

And it has completed a US phase I trial for cancer drug Telomelysin, and plans a phase I/II study in Taiwan with Medigen Biotechnology Corp.

The compound is a first-in-class product using oncolytic adenovirus technology which replicates and spreads within solid tumours, killing cancer cells without harming healthy ones.

Adam Hill

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