Bristol-Myers Squibb Statement on Sustiva (efavirenz) in the U.S.
PRINCETON, N.J., Oct 08, 2014 (BUSINESS WIRE) -- Bristol-Myers Squibb Company BMY, +0.41% has successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva (efavirenz) and Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017.
Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor (BMS-663068), an HIV-1 maturation inhibitor (BMS-955176) and an anti-PD-L1 (BMS-936559).
The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world.
Please click here for the SUSTIVA US Full Prescribing Information.
Please click here for the Atripla US Full Prescribing Information, including Boxed WARNINGS.
Bristol-Myers Squibb Forward-Looking Statement
This statement contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Bristol-Myers Squibb will be able to retain patent exclusivity on efavirenz through the period stated above. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
SOURCE: Bristol-Myers Squibb Company