AstraZeneca (AZN - Free Report) and its partner Bristol-Myers Squibb Company (BMY - Free Report) recently announced disappointing top-line data from a phase IV study (SAVOR-TIMI-53; n = 16,500) on their diabetes drug, Onglyza, a dipeptidyl peptidase-4 (DPP-4) inhibitor. Detailed data from the study is expected to be presented at the European Society of Cardiology (ESC) meeting scheduled in Sep 2013.
The randomized, double-blind, placebo-controlled phase IV 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.
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 or non-fatal ischaemic stroke. However, the drug met the primary safety objective of non inferiority.
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 generated sales of $202 million in the first quarter of 2013, reflecting an increase of 25% over the year-ago period.
The drug is contraindicated in patients with serious hypersensitivity reaction history to Onglyza. Several post-marketing reports hinted at a correlation between acute pancreatitis and serious hypersensitivity reactions and Onglyza.
We believe positive data from the study would have increased Onglyza’s share in the DPP-4 inhibitor market and provided a much needed boost to AstraZeneca and Bristol-Myers' revenues. We note that key products from both AstraZeneca and Bristol-Myers are facing generic competition
AstraZeneca and Bristol-Myers both carry a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Biogen Idec (BIIB - Free Report) and Novo Nordisk (NVO - Free Report) . While Biogen is Zacks Rank #1 (Strong Buy) stock, Novo Nordisk is a Zacks Rank #2 (Buy) stock.