A positive direction for HIV
February 2011
by Amy Swinderman  |  Email the author


TOKYO—Continuing its global fight against HIV/AIDS, Bristol-Myers Squibb Co. (BMS) has signed a licensing agreement with Oncolys Biopharma Inc., a privately held biotechnology company based in Japan, for an investigational HIV compound.
Under the agreement, announced Dec. 20, BMS will manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV. In return, Oncolys is eligible to earn up to $286 million in upfront, development, regulatory and sales milestone payments, in addition to unspecified tiered royalties on the worldwide product sales.

Festinavir was synthesized by a group of researchers in collaboration with Yale University. Oncolys BioPharma in-licensed the compound from Yale in 2006 with global rights for development, manufacturing and commercialization.

The compound is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks HIV-1 reverse transcriptase, the essential enzyme for viral replication. Festinavir has shown to be effective against various key resistant and mutations, and the compound has a promising safety profile. Oncolys says it is conducting a number of studies to confirm its expectations of safety and resistance.

Neither company responded to a request for comment by press time. BMS has described HIV/AIDS as a "top priority" for the company. According to the Joint United Nations Programme on HIV/AIDS, there are 33.2 million people living with HIV/AIDS around the world.

"We are exploring new ways to attack the AIDS virus and new ways to help make treatments simpler for patients to take," the company says on its website.

In a statement announcing the deal, Brian Daniels, senior vice president of development at BMS, said, "Bristol-Myers Squibb has been dedicated to helping patients prevail over HIV for more than two decades and is committed to the ongoing discovery, development and delivery of medicines to fight HIV/AIDS globally. The profile of festinavir offers the possibility of improvement in the safety of long-term HIV treatment, an area of significant unmet medical need."

Founded in 2004, Oncolys's strategic focus is "to maximize and realize the potential of our products through partnering." According to the company's website, Oncolys is seeking other commercial partners for some of its other projects in development: Telomelysin and OBP-801, two oncology programs, and telomescan, a cancer diagnostic and navigation surgery program. In October 2009, Oncolys signed a deal with Astellas Pharma to develop and commercialize YM753, an HDAC inhibitor drug. In January 2009, Oncolys also joined forces with Sysmex Corp. for an in-vitro cancer circulating tumor cell diagnostic agent.

Oncolys President and CEO Yasuo Urata said in a statement, "For many years, I have been working for the development of medicines in the fight against HIV/AIDS, and I'm convinced that festinavir has the possibility to be a potent and effective NRTI with a promising resistance profile. Also, festinavir's once-daily dosage is essential for treating HIV patients worldwide."
Code: E021105

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