Generic competition has adversely impacted
) revenues over the past few quarters. This has put significant
pressure on the company. AstraZeneca is looking towards
cost-cutting initiatives to drive the bottom line in the face of
The company expects to boost its pipeline by acquiring
candidates. In a bid to add late-stage candidates to its
pipeline, AstraZeneca entered into a number of acquisition deals
(Pearl Therapeutics and Omthera Pharmaceuticals) in the last few
months and struck agreements with companies like FibroGen, Inc.
The acquisition of Omthera Pharma added Epanova to AstraZeneca's
pipeline. The candidate has been developed for the treatment of
patients with severe hypertriglyceridaemia (triglyceride levels
greater than or equal to 500mg/dL). The U.S. Food and Drug
Administration (FDA) accepted the marketing application for
Epanova and is expected to render a final decision on the
candidate by May 5, 2014.
In 2012, encouraging efficacy data on Epanova from two phase III
trials (EVOLVE and ESPRIT), conducted under the FDA's Special
Protocol Assessment, were released.
It was found that Epanova lowered very high triglycerides and
reduced non-high-density lipoprotein cholesterol as an adjunct to
a statin in patients with high triglycerides.
AstraZeneca also intends to get Epanova approved as a fixed dose
combination with its cardiovascular drug, Crestor, for mixed
dyslipidemia patients who are at a high risk of cardiovascular
events. Moreover, AstraZeneca is planning to conduct a large
scale cardiovascular outcomes trial to assess Epanova in
combination with statins.
We note that, erstwhile Omthera had entered into an exclusive
license agreement with Chrysalis Pharma under which it acquired
an exclusive global license for the development, manufacture, and
commercialization of Epanova.
AstraZeneca carries a Zacks Rank #3 (Hold). At present, large-cap
pharma companies like
) look well-positioned. While Roche is a Zacks Ranked #1 (Strong
Buy) stock, Novo Nordisk and Bayer carry a Zacks Rank #2
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