- As a monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance; or
- In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Bristol-Myers Squibb and AstraZeneca CollaborationBristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to research, develop and commercialise select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca diabetes collaboration is dedicated to global patient care and improving patient outcomes in the treatment of type 2 diabetes. The portfolio of type 2 diabetes products developed as a part of the Bristol-Myers Squibb and AstraZeneca collaboration includes the first-in-class SGLT2 inhibitor Forxiga ™ (dapagliflozin), the DPP4 inhibitor Onglyza ® (saxagliptin), Komboglyze ™ (saxagliptin and metformin HCl immediate-release fixed dose combination) and Kombiglyze XR ™ (saxagliptin and metformin HCl extended-release fixed dose combination), which is only available outside the European Union. In August 2012, Bristol-Myers Squibb completed the acquisition of Amylin Pharmaceuticals. Bristol-Myers Squibb and AstraZeneca then expanded their existing alliance in diabetes to incorporate Amylin’s portfolio of diabetes products, which includes GLP1s Byetta ® (exenatide injection) and Bydureon ™ (exenatide extended-release for injectable suspension), both the first to be approved in their class and now available in the U.S. and Europe, as well as the first-in-class Amylin mimetic Symlin ® (pramlintide acetate injection), which is only available in the U.S. Eli Lilly and Amylin amicably terminated their joint collaboration in November 2011 for exenatide and began to transition global responsibility for the exenatide franchise to Amylin, starting in the U.S. and targeting the transition for all markets by the end of 2013. Bristol-Myers Squibb and AstraZeneca are now working to transition markets outside the U.S. in which Lilly markets and sells exenatide into the expanded Bristol-Myers Squibb and AstraZeneca alliance. 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.
About AstraZenecaAstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Bristol-Myers Squibb Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 Forxiga will become a commercially successful product in the EU or that it will be approved in other jurisdictions. 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, 2011, 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. AstraZeneca Forward-Looking Statement The statements contained herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report and Form 20-F Information 2011. Nothing contained herein should be construed as a profit forecast. Forxiga ™ is a registered trademark of Bristol-Myers Squibb Company.