FDA Approves ONGLYZA For The Treatment Of Type 2 Diabetes In The US

Saturday, 1 August 2009

AstraZeneca and Bristol-Myers Squibb today announced that the US Food and Drug Administration (FDA) has approved ONGLYZA (saxagliptin) for the treatment of type 2 diabetes mellitus in adults.

ONGLYZA is a dipeptidyl peptidase-4 (DPP-4) inhibitor. DPP-4 inhibitors affect the action of incretins, hormones that decrease elevated blood sugar levels (glucose) by increasing the body’s utilisation of sugar, mainly through increasing insulin production in the pancreas and by reducing the liver’s production of glucose.

ONGLYZA is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults with type 2 diabetes mellitus. ONGLYZA once daily can be used in combination with commonly prescribed oral anti-diabetic medications – such as metformin, sulfonylureas (SUs) or thiazolidinediones (TZDs) – or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. The dose of ONGLYZA is 2.5 mg or 5 mg, once daily, regardless of meals.

“Type 2 diabetes is a daily challenge for adult patients and physicians. With the FDA approval of ONGLYZA, physicians and adult patients with type 2 diabetes have an important new treatment to help improve glycemic control,” said David Brennan, Chief Executive Officer, AstraZeneca. “ONGLYZA is the product of a major collaboration between AstraZeneca and Bristol-Myers Squibb to further the understanding of how best to treat this challenging disease and help adult patients achieve their treatment goals.”


AstraZeneca and Bristol-Myers Squibb Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes – one of which is saxagliptin. 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 AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life.

ONGLYZA is a trademark of the Bristol-Myers Squibb Company.


AstraZeneca Media Enquiries UK:
Neil McCrae +44 20 7304 5045 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Sarah Lindgreen +44 20 7304 5033 (24 hours)

AstraZeneca Media Enquiries US:
Laurie Casaday +1 302 290 2624

Bristol-Myers Squibb Media Enquiries:
Carmel Hogan +33 674 107 658

AstraZeneca Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032

AstraZeneca Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043

Bristol-Myers Squibb Investor Enquiries:
John Elicker +1 609 252 4611


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