December 18, 2015
By Mark Terry, BioSpace.com Breaking News Staff
London-based GlaxoSmithKline announced today that it had made two separate deals with New York-based Bristol-Myers Squibb for two HIV-related assets.
GSK’s ViiV Healthcare, its worldwide HIV business, inked two deals with Bristol-Myers. The first, late-stage HIV drug, fostemsavir (BMS-663068), is currently in Phase III clinical trials for patients who have a lengthy treatment history. The compound was given Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). It is expected to be submitted for regulatory approval in 2018.
A second late-stage asset is BMS-955176, a maturation inhibitor. This compound is presently in Phase IIb development for treatment-naïve and treatment experienced patients. A third candidate, BMS-986173, a back-up maturation inhibitor, is also part of the late-stage asset package.
The second deal is for compounds in preclinical and discovery development for HIV. The primary compound in this category is BMS-986197, which has three mechanisms of action: maturation inhibition, an allosteric integrase inhibitor, and a capsid inhibitor.
The deal also allows for some of the Bristol-Myers Squibb employees involved in the drug discovery program to transfer to ViiV Healthcare.
The late-stage deal includes an upfront payment of $317 million. Additional milestone payments could hit $518 million, and there are tiered royalties on sales.
The preclinical stage deal has an upfront payment of $33 million. Milestone payments could reach $587 million, with additional payments based on sales.
“These acquisitions strengthen our leadership and innovation in HIV, one of our core areas of scientific research at GSK,” said David Redfern, GSK’s chief strategy officer and chairman of ViiV Healthcare, in a statement. “The addition of two potential first-in-class late-stage treatments and several promising early clinical development programs strengthens ViiV Healthcare’s pipeline and provides us with further new opportunities for growth.”
In June 2015, Bristol-Myers Squibb indicated it was shifting its focus away from virus research and concentrating more on immuno-oncology. This sale of HIV assets to GSK is consistent with that decision.
“Bristol-Myers Squibb has been committed to the HIV community for almost three decades, contributing significantly to the science and to the transformation in the treatment of this disease,” said Francis Cuss, Bristol-Myers Squibb’s chief scientific officer, in a statement. “Given the remaining unmet medical needs in HIV, Bristol-Myers Squibb continued its discovery of novel treatment approaches and the agreements with ViiV Healthcare now put the development of these potentially first-in-class compounds into the hands of a global specialist company exclusively dedicated to finding new medicines for people living with HIV.”
About 22 percent of GSK’s ViiV Healthcare is owned by Pfizer Inc. and Shionogi & Co. According to BloombergBusiness, in 2014 ViiV’s earnings alone were worth more than 25 percent of GSK’s operating profit. GSK had considered spinning off ViiV, but abandoned the plan in May after investors indicated they wished ViiV to remain as part of the company.
Keyur Parekh, an analyst with Goldman Sachs Group Inc., wrote in a Friday note, “If successful, the late-stage assets would represent new growth drivers post-2020 as Glaxo’s key HIV products Tivicay and Triumeq mature.”
