KOMBOGLYZE(TM) Receives Marketing Authorisation in the European Union for Adult Patients With Type 2 Diabetes

By Bristol-myers Squibb Astrazeneca, PRNE
Monday, November 28, 2011

PARIS and LONDON, November 29, 2011 -

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE/LSE: AZN) announced today that the European Commission has granted marketing authorisation for KOMBOGLYZETM (saxagliptin and metformin HCl immediate-release fixed dose combination) that will cover the 27 Member States of the European Union.  

The indication for KOMBOGLYZE is as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with Type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.

KOMBOGLYZE combines saxagliptin (ONGLYZA®)*, a DPP-4 inhibitor, and metformin immediate-release (metformin IR), a biguanide, in one convenient tablet for the treatment of Type 2 diabetes. The approval of KOMBOGLYZE is based on a saxagliptin development programme that involved 4,326 patients, including 2,158 individuals receiving saxagliptin plus metformin. In the development programme, saxagliptin and metformin were administered as separate components. The bioequivalence of KOMBOGLYZE to co-administered saxagliptin and metformin was demonstrated in additional studies.

* Onglyza received Marketing Authorisation in 2009 and is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control: in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.[1] 

About Type 2 Diabetes

By the end of 2011, diabetes is estimated to affect nearly 53 million people aged 20-79 in Europe, and this figure is projected to rise to more than 64 million by 2030.[2] Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterised by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated blood glucose levels. Over time, this sustained hyperglycaemia contributes to worsening insulin resistance and further beta cell dysfunction. Significant unmet needs exist as nearly half of treated patients remain uncontrolled on their current glucose-lowering regimen.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies 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, improving patient outcomes and creating a new vision for the treatment of Type 2 diabetes.

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 AstraZeneca

AstraZeneca 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 Komboglyze will become a commercially successful product. 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, 2010, 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 2010. Nothing contained herein should be construed as a profit forecast.


1. Onglyza Summary of Product Characteristics. October 2011

2. International Diabetes Federation (IDF). IDF Diabetes Atlas. 5th Edition. November 2011. www.idf.org/diabetesatlas/ [Last accessed: 14 November 2011]

Media: Carmel Hogan, Bristol-Myers Squibb, +33-6-74-10-76-58, carmel.hogan at bms.com; Michele Meixell, AstraZeneca, +1-610-662-3589, michele.meixell at astrazeneca.com;
Investors: John Elicker, Bristol-Myers Squibb, +1-609-252-4611, john.elicker at bms.com; Karl Hard, AstraZeneca, +44-20-7604-8123, karl.j.hard at astrazeneca.com

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