saxagliptin

BMS, AstraZeneca present saxagliptin data

Maureen Martino — Tue, 09 Sep 2008 09:36:07 -0400

Bristol-Myers Squibb and AstraZeneca presented results from a 24-week Phase III study of Onglyza (the proposed trade name for saxagliptin). When used in combination with metformin, the drug produced significant reductions across all key measures of the glucose control studied.

The results were unveiled at the 44th European Association for the Study of Diabetes Annual Meeting. An NDA has already been submitted to the FDA and EMEA. If approved the drug could bring in $2 billion a year and will compete with Merck's DPP-4 inhibitor Januvia.

- check out the release

FDA panel backs added risk review on diabetes drugs

John Carroll — Thu, 03 Jul 2008 09:58:10 -0400

A FDA advisory panel has voted 14-2 to recommend that the developers of diabetes drugs specifically demonstrate that their experimental therapies don't increase cardiovascular risks. And if as expected the agency follows the recommendation, developers in the diabetes field are looking at more complex trial demands that are likely to add significant cost to the trials process. The Wall Street Journal nominates AstraZeneca and Bristol-Myers Squibb as the first two biopharma companies to face the new standard. Their diabetes drug saxagliptin is headed to the FDA for a review.

- read the report in the Wall Street Journal

DPP-4 inhibitors get spotlight at ADA meeting

John Carroll — Mon, 09 Jun 2008 11:55:40 -0400

Researchers are unveiling positive data at the American Diabetes Association's meeting for new DPP-4 inhibitors for diabetes. Takeda is the latest, demonstrating that its alogliptin can control blood sugar alone or in combination with other therapies. AstraZeneca has already presented data on saxagliptin. Taken for 26 weeks, says Takeda, alogliptin can cut hemoglobin A1C by 0.6 percent at its strongest dose. DPP-4s have a mixed record. Merck has a therapy on the market--Januvia--while Novartis' Galvus has yet to be approved.

Merck, meanwhile, revealed new data backing Januvia, saying the drug targets key cells in attacking diabetes. And researchers said the DPP-4 inhibitor reduced the risk of hypoglycaemia, a potentially fatal side effect.

- read the AFX report
- read the story from Hemscott

1. AstraZeneca and Bristol-Myers Squibb

Maureen Martino — Tue, 11 Sep 2007 08:52:45 -0400

Who: AstraZeneca
With: Bristol-Myers Squibb
What: $1.05 billion collaboration

Summary: In an unusual partnership between drug giants, AstraZeneca agreed to pay Bristol-Myers Squibb $100 million up front and up to $950 million more in milestones to partner up on two new drugs for the hot diabetes market. AstraZeneca has also agreed to take on 75 percent of the development costs of both late-stage compounds, saxagliptin and dapagliflozin. The companies will split global sales and revenue on both products. Release

Related Articles:
BMS unveils positive diabetes data. Report
AstraZeneca, BMS ink billion-dollar pact on diabetes drugs. Report