AstraZeneca (AZN - Free Report) recently announced full data from the SAVOR study (n = 16,492) on its diabetes drug, Onglyza, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Onglyza failed to meet the primary efficacy endpoint of the study.
Onglyza did not prove to be superior to placebo with respect to a composite endpoint including cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke. However, the drug met the primary safety objective of non inferiority to placebo for the same composite endpoint.
The randomized, double-blind, placebo-controlled study evaluated the use of Onglyza as a combination therapy in patients suffering from type II diabetes, with a history of established cardiovascular disease or multiple risk factors. Some of these patients also suffered from renal impairment. It was found in the study that the primary composite endpoint of cardiovascular death, non-fatal MI or non-fatal ischemic stroke occurred in 7.3% of the patients in the Onglyza arm as compared to 7.2% in the placebo arm.
AstraZeneca has a collaboration agreement with Bristol-Myers Squibb Company for the drug.
We note that Onglyza is approved as an adjunct to diet and exercise to improve glycemic (blood sugar) control in adults suffering from type II diabetes. Onglyza revenues as recorded by AstraZeneca were $102 million in the second quarter of 2013, reflecting an increase of 28% over the year-ago period.
We believe positive data from the study would have increased Onglyza’s share in the DPP-4 inhibitor market providing a much needed boost to AstraZeneca’s revenues. We note that key products from AstraZeneca are facing generic competition
Key players in the diabetes market include Novo Nordisk (NVO - Free Report) and Sanofi (SNY - Free Report) among others.
AstraZeneca carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Biogen Idec (BIIB - Free Report) , carrying a Zacks Rank #1 (Strong Buy).