New Data for Investigational Diabetes Drug Saxagliptin Demonstrates Potential for Type 2 Diabetes Treatment

Results from a 24-week Phase III study presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrated that saxagliptin, an investigational selective inhibitor with extended binding to the dipeptidyl peptidase-4 (DPP-4) enzyme, in development by Bristol-Myers Squibb Company and AstraZeneca, when used in combination with metformin as an initial therapy, produced reductions across all key measures of glucose control studied [glycosylated hemoglobin level (A1C), fasting plasma glucose (FPG) and postprandial glucose (PPG)] in treatment-naïve people with inadequately controlled type 2 diabetes, compared with monotherapy with saxagliptin or metformin. The initial combination of saxagliptin and metformin was well tolerated during the course of the study, and more people were able to achieve target A1C of less than 7 percent, compared with monotherapy with saxagliptin or metformin.

“With these new data, Phase III studies for saxagliptin have demonstrated that saxagliptin improved key markers for glucose control when given with standard therapies for type 2 diabetes and as a monotherapy,” said Professor Anthony Barnett, University of Birmingham and Heart of England NHS Foundation Trust. “The clinical trial programme for saxagliptin evaluated more than 5,000 individuals, including more than 4,000 who were given saxagliptin.”

The companies submitted a New Drug Application to the U.S. Food & Drug Administration (FDA) on 30 June, which has been officially filed by the FDA, and a Marketing Authorisation Application to the European Medicines Agency (EMEA) on 1 July, which has been accepted for review by the Agency. The submissions are based on data from a comprehensive clinical trial programme conducted in addition to standard therapies, as well as in treatment-naïve patients as a monotherapy. The clinical trial programme included studies that evaluated the drug at up to 80 times the proposed usual clinical dose of 5 mg, once daily. The six core Phase III trials assessing the efficacy and safety profile of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.

# # #

September 9, 2008

Saxagliptin Enquiries:
Jim Minnick   +1 302 886 5135 mob: +1 610 457 1828

Media Enquiries:
Chris Sampson   +44 20 7304 5130 (24 hours)
Neil McCrae   +44 207 304 5045 (24 hours)

Investor Enquiries UK:
Jonathan Hunt   +44 207 304 5087     mob: +44 7775 704032
Mina Blair          +44 20 7304 5084     mob: +44 7718 581021
Karl Hard          +44 207 304 5322      mob: +44 7789 654364

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
Peter Vozzo (MedImmune) +1 301 398 4358        mob: +1 301 252 7518