AZ and BMS combine to develop new diabetes drugs
pharmafile | January 19, 2007 | News story | Sales and Marketing |Â Â Â
AstraZeneca and Bristol-Myers-Squibb are collaborating on the development of two new drugs for the treatment of type II diabetes.
Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is currently in phase III trials and the companies plan to file it with US regulators during the first half of 2008.
Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, is currently in phase IIb development.
If given the green light by the US, Saxagliptin will rival Merck's Januvia, which received FDA approval last October as a monotherapy and as an add-on treatment with either melformin or a thiazolidinedione.
It could also come up against Novartis' Galvus, which, after a surprise delay due to concerns over its safety, is likely to be approved by US regulators in February.
Bristol-Myers-Squibb (BMS) will receive an upfront payment of $100 million from AstraZeneca, and AZ will fund the majority of the drug's development costs over the next two years.
BMS may also receive additional payments of up to $650 million based on development and regulatory milestones for the two compounds.
David Brennan, AZ's chief executive, said: "Diabetes is a disease reaching almost epidemic proportions in many regions of the world and is a particular area of scientific interest to AstraZeneca."
He added:"This deal represents a significant step in delivering our externalisation strategy as it gives us access to two strategically important late-stage compounds in an area of high unmet need."
DPP-4 class of inhibitors work by increasing and prolonging the action of natural hormones in the body, known as incretins. These decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing the production of insulin in the pancreas and reducing production of sugar by the liver.
By enhancing the effect of active incretin hormones in the body, DPP-4 inhibitors improve timely insulin release and ultimately decrease high blood sugar levels in patients with type II diabetes.
It is estimated that there are currently more than 230 million people living with diabetes worldwide.
In November 2005, the FDA wrote to a number of companies developing DPP-4 treatments requesting more information on three-month primate studies, following reports of skin toxicity, which were not seen in any other species, including humans.
The request came following reports of skin problems in primates from an unknown DPP-4 drug which was not Galvus, Januvia or GlaxoSmithKlines Redona.
Analysts Lehman Brothers said it was not clear whether either AstraZeneca or Takeda – or any other company – contacted the FDA over skin toxicity concerns, but the outcome has set back Novartis' Galvus by at least three months.
