) and its partner
Bristol-Myers Squibb Company
) 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
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.
ASTRAZENECA PLC (AZN): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
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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
). While Biogen is Zacks Rank #1 (Strong Buy) stock, Novo Nordisk
is a Zacks Rank #2 (Buy) stock.