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GSK Strengthens HIV Drug Pipeline

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GlaxoSmithKline has  announced that its global HIV business, ViiV Healthcare, has reached two separate agreements with Bristol-Myers Squibb, to acquire its late-stage HIV R&D assets; and to acquire Bristol-Myers Squibb’s portfolio of preclinical and discovery stage HIV research assets.

Under the terms agreed in the two transactions, ViiV Healthcare will acquire:

Late stage assets, including fostemsavir (BMS-663068), an attachment inhibitor, currently in phase III development for heavily treatment experienced patients. Fostemsavir has received a Breakthrough Therapy Designation from the FDA and is expected to be filed for regulatory approval in 2018. The second late stage asset is a maturation inhibitor (BMS-955176), currently in phase IIb development for both treatment-naive and treatment experienced patients. A back-up maturation inhibitor candidate (BMS-986173) is also included in the purchase.

Assets in preclinical and discovery phases of development including a novel biologic (BMS-986197) with a triple mechanism of action, a further maturation inhibitor, an allosteric integrase inhibitor and a capsid inhibitor. A number of Bristol-Myers Squibb drug discovery employees will also be offered the opportunity to transfer to ViiV Healthcare.

These potential therapies have novel modes of action and would offer significant new treatment options to patients with HIV. In addition to being developed as standalone treatment options, these new assets complement ViiV Healthcare’s existing portfolio and therefore offer multiple opportunities for development as combination therapies.

The late-stage asset purchase comprises an upfront payment of $317 million, followed by development and first commercial sale milestones of up to $518M, and tiered royalties on sales.

The purchase of preclinical and discovery stage research assets comprises an upfront payment of $33 million, followed by development and first commercial sales milestones of up to $587M, and further consideration contingent on future sales performance.

David Redfern, Chief Strategy Officer at GSK and Chairman of ViiV Healthcare, said: “These acquisitions strengthen our leadership and innovation in HIV, one of our core areas of scientific research at GSK. The addition of two potential first-in-class late-stage treatments and several promising early clinical development programmes strengthens ViiV Healthcare’s pipeline and provides us with further new opportunities for growth.”

The two transactions are anticipated to complete independently during the first half of 2016, subject to necessary approvals, anti-trust and regulatory clearances. 

GSK has been a leader in research and development of HIV since the 1980s, with the development of the world’s first breakthrough medicine for HIV patients, Retrovir (zidovudine). Development of new treatment options has continued, with Tivicay (dolutegravir) and Triumeq (dolutegravir/ abacavir/lamivudine), the most recent successful innovation. Research programmes are ongoing to develop new treatments and improve drug regimens, including the investigational long-acting integrase inhibitor, cabotegravir. Established in 2009, ViiV Healthcare is a specialist global HIV company, majority owned by GSK, with Pfizer and Shionogi as other shareholders.