Bristol-Myers Squibb Statement on Sustiva (efavirenz) in the U.S.
October 08 2014 - 7:00AM
Business Wire
Bristol-Myers Squibb Company (NYSE:BMY) 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.
Bristol-Myers Squibb CompanyMedia:Laura Hortas,
609-252-4587laura.hortas@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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