Significant New Data For Investigational Diabetes Drug Saxagliptin Demonstrates Potential For Type 2 Diabetes Treatment

Main Category: Diabetes
Article Date: 10 Sep 2008 - 4:00 PDT

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New data presented for the first time at the 44th European Association for the Study of Diabetes (EASD) Annual Meeting have added to the growing body of evidence, which demonstrates the potential of the investigational drug, saxagliptin, for the treatment of type 2 diabetes. Results from three Phase III studies presented at the European meeting, have shown that when used in combination with standard therapies, saxagliptin produced significant reductions across all key measures of glucose control in both treatment-naïve and treatment-experienced patients with inadequately controlled diabetes.

Saxagliptin, a selective DDP-4 inhibitor, has now shown in five Phase III studies to improve key markers for glucose control when given with standard therapies for type 2 diabetes, and demonstrate a similar safety profile in comparison to placebo or the comparator product. Saxagliptin has also been investigated for use in patients with renal or hepatic impairment.

There are currently over 2.3 million people with diabetes in the UK. In addition, there are over half a million people in the UK who have diabetes and do not know it.iv In the UK, the "cost" of diabetes is estimated to be 5% of all NHS expenditure.v In 2002, it was estimated that the total annual cost of diabetes to the NHS was £1.3billion, with much spent on managing avoidable diabetes complications.

"A large number of people with type 2 diabetes have difficulty managing their disease and remain uncontrolled on present therapies," said Professor Anthony Barnett, University of Birmingham and Heart of England NHS Foundation Trust. "Given the growing numbers of people with diabetes around the world, it is an important advantage to have new therapies as we fight this chronic disease."

Three studies investigating the potential of saxagliptin have been presented at the EASD. Two studies analysed the effect of saxagliptin when used in combination with thiazolidinedione (TZD) or a sulphonylurea in people with inadequately controlled type 2 diabetes. The studies concluded that saxagliptin, when used in combination, produced significant reductions across all key measures of glucose control studied [glycosylated hemoglobin level (A1C), fasting plasma glucose (FPG) and postprandial glucose (PPG)].ii,iii In addition, when used in combination with metformin as an initial therapy in treatment-naïve people with inadequately controlled type 2 diabetes, saxagliptin produced significant reductions across all the same key measures of glucose control studied.

Saxagliptin is being co-developed by Bristol-Myers Squibb (BMS) and AstraZeneca (AZ,) in order to address the current un-met medical need in the area of diabetes. The BMS and AZ arrangement is the start of a longer term commitment, which may also lead to the co-development of a potential first in class treatment, dapagliflozin.

The companies submitted a New Drug Application for saxagliptin to the U.S. Food & Drug Administration (FDA) on June 30 and a Marketing Authorization Application to the European Medicines Agency (EMEA) on July 1, 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 five 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 Saxagliptin

Saxagliptin is an investigational DPP-4 inhibitor under co-development by Bristol-Myers Squibb and AstraZeneca 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 profile. Saxagliptin was specifically designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance.

Saxagliptin Phase III data has previously been presented as a monotherapy, as well as in combination with metformin, sulphonylureas and thiazolidinediones, commonly prescribed oral anti-diabetic medications.

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 use of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver's production of glucose.

Bristol-Myers Squibb and AstraZeneca arrangement

Bristol-Myers Squibb and AstraZeneca entered into co-development agreement in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes - saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca co-development is dedicated to global patient care, improving patient outcomes and creating a new treatment paradigm for patients with type 2 diabetes.

About Bristol-Myers Squibb

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

Bristol-Myers Squibb

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.

AstraZeneca