A positive direction for HIV

Bristol-Myers Squibb and Oncolys BioPharma in nearly $300 million licensing deal for investigational HIV compound

Amy Swinderman
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TOKYO—Continuing its global fight against HIV/AIDS,Bristol-Myers Squibb Co. (BMS) has signed a licensing agreement with OncolysBiopharma Inc., a privately held biotechnology company based in Japan, for aninvestigational HIV compound.

 
Under the agreement, announced Dec. 20, BMS willmanufacture, develop and commercialize festinavir, a once-a-day, orallyavailable nucleoside reverse transcriptase inhibitor (NRTI) in Phase IIdevelopment for HIV. In return, Oncolys is eligible to earn up to $286 millionin upfront, development, regulatory and sales milestone payments, in additionto unspecified tiered royalties on the worldwide product sales.

Festinavir was synthesized by a group of researchers incollaboration with Yale University. Oncolys BioPharma in-licensed the compoundfrom Yale in 2006 with global rights for development, manufacturing andcommercialization.

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

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

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

In a statement announcing the deal, Brian Daniels, seniorvice president of development at BMS, said, "Bristol-Myers Squibb has beendedicated to helping patients prevail over HIV for more than two decades and iscommitted to the ongoing discovery, development and delivery of medicines tofight HIV/AIDS globally. The profile of festinavir offers the possibility ofimprovement in the safety of long-term HIV treatment, an area of significantunmet medical need."

Founded in 2004, Oncolys's strategic focus is "to maximizeand realize the potential of our products through partnering." According to thecompany's website, Oncolys is seeking other commercial partners for some of itsother projects in development: Telomelysin and OBP-801, two oncology programs,and telomescan, a cancer diagnostic and navigation surgery program. In October2009, Oncolys signed a deal with Astellas Pharma to develop and commercializeYM753, an HDAC inhibitor drug. In January 2009, Oncolys also joined forces withSysmex Corp. for an in-vitro cancercirculating 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 thefight against HIV/AIDS, and I'm convinced that festinavir has the possibilityto be a potent and effective NRTI with a promising resistance profile. Also,festinavir's once-daily dosage is essential for treating HIV patientsworldwide."

Amy Swinderman

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