Regulatory Application

RNS Number : 7093Z

AstraZeneca PLC

23 July 2008

 



ASTRAZENECA AND BRISTOL-MYERS SQUIBB SUBMIT NEW DRUG APPLICATION IN THE UNITED STATES AND MARKETING AUTHORIsATION APPLICATION IN EUROPE FOR ONGLYZA™ (saxagliptin) FOR THE TREATMENT OF TYPE 2 DIABETES

AstraZeneca and Bristol-Myers Squibb Company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA™ (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by AstraZeneca and Bristol-Myers Squibb for the treatment of type 2 diabetes. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.

The NDA and MAA submissions for saxagliptin are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses.  The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.

About ONGLYZA™ (saxagliptin)

ONGLYZA™ (saxagliptin), a DPP-4 inhibitor, is an investigational drug under joint development by

AstraZeneca and Bristol-Myers Squibb for the treatment of type 2 diabetes. Saxagliptin is being

studied in clinical trials as a once-daily therapy to determine its efficacy and safety.  Saxagliptin 

was specifically designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with

dual routes of clearance. Phase III data for saxagliptin have previously been presented in

combination with metformin, the most commonly prescribed oral anti-diabetic, as well as when

used as monotherapy in treatment-naïve individuals. Additional Phase III data for saxagliptin,

including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy

with metformin, are planned for disclosure later this year. 

About DPP-4 Inhibitors

DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins 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.

About Type 2 Diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a
role.  Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.

AstraZeneca and Bristol-Myers Squibb Collaboration

AstraZeneca and Bristol-Myers Squibb entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise two investigational drugs for type 2 diabetes -saxagliptin and dapagliflozin. The AstraZeneca/Bristol-Myers Squibb 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 extend and

enhance human life. 

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com

ONGLYZA™ (saxagliptin) is a trademark of the Bristol-Myers Squibb Company

23 July 2008

AstraZeneca contacts:

Media Enquiries:

Steve Brown           [phone] (24 hours)

Chris Sampson      [phone] (24 hours)

Neil McCrae            [phone] (24 hours)

Jim Minnick             [phone]

Investor Enquiries UK:

Jonathan Hunt                 [phone]      mob: [phone]

Mina Blair                        [phone]      mob: [phone]

Karl Hard                         [phone]      mob: [phone]

Investor Enquiries US:

Ed Seage                                   [phone]      mob: [phone]

Jorgen Winroth                          [phone]      mob: [phone]

Peter Vozzo (MedImmune)       [phone]      mob: [phone]

Bristol-Myers Squibb contacts:

Media enquiries

David M. Rosen: [phone]
[e-mail]

Investors

John Elicker: [phone]
[e-mail]

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