Bristol-Myers Seeks Approval for HIV Combo Drug - Analyst Blog

Bristol-Myers Squibb Company BMY announced that it has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) earlier in the month (Apr 4, 2014) seeking approval for a fixed-dose combination of its established HIV treatment Reyataz (atazanavir sulfate) and Gilead Sciences' GILD cobicistat for treating the virus. While Reyataz is a protease inhibitor, Cobicistat is a boosting agent -- the addition of which increases the efficacy of certain HIV-1 therapies by elevating their levels in the blood.

Bristol-Myers is looking to get the once-daily, single tablet fixed-dose combination approved in conjunction with other antiretroviral agents for the treatment of HIV-1 infection. Approval of the cocktail treatment would simplify matters for HIV-1 patients by eliminating the need to take a boosting agent in a separate tablet.  

Bristol-Myers stated in its press release that Reyataz is the only protease inhibitor to be studied in combination with cobicistat in a randomized, phase III study (Gilead's study 114). The double-blind study compared the efficacy and safety of cobicistat-boosted Reyataz with Reyataz boosted by AbbVie's ABBV HIV therapy Norvir (ritonavir)  over 48 weeks in treatment naïve HIV infected adults. We believe investors will certainly look forward to further updates on the fixed-dose combination therapy.

We remind investors that Bristol-Myers and Gilead teamed up in 2011 developing and commercializing the once-daily, single tablet fixed-dose combination. According to the deal, Bristol-Myers is responsible for the formulation, manufacturing, registration, distribution and commercialization of the cocktail therapy across the globe. Gilead is exclusively responsible for the manufacture, development and commercialization of cobicistat as a stand-alone therapy and for use in combination with other agents.

Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). A better-ranked stock in the biopharma space is Regeneron Pharmaceuticals REGN, carrying a Zacks Rank #1 (Strong Buy).