alliance to develop novel therapies for the treatment of type 2 diabetes. Today we will
present the results of our development program for Saxagliptin, a highly potent, selective
and reversible DPP-4 inhibitor. We are seeking an indication for Saxagliptin to improve
glycemic control in patients with type 2 diabetes, as an adjunct to diet and exercise, when
used as monotherapy, combination therapy with Metformin, a TZD, or a Sulfonylurea,
and as initial combination therapy with Metformin. A robust clinical development
program was conducted where a total of 5,346 subjects were evaluated in phases 1
through 3. Treatment with Saxagliptin resulted in consistent clinically meaningful and
statistically significant reductions in HbA1c, fasting plasma glucose, and postprandial
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JOSEPH LAMENDOLA, PH.D.
Joffe. We will now proceed with the Sponsor presentations. I would like to remind
public observers at this meeting that while the meeting is open for public observation,
public attendees may not participate except at the specific request of the panel. I believe
Dr. Lamendola is the first speaker.
Mr. Chairman, Members of the Endocrine and Metabolic Drugs Advisory
Committee and FDA, good morning. My name is Joe Lamendola and I’m Vice President
DR. BURMAN: Thank you very much. Thank you very much, Dr.
of Global Regulatory Sciences for Bristol-Myers Squibb.
In January of 2007 Bristol-Myers Squibb and AstraZeneca formed an