AstraZeneca’s Late-Stage Pipeline Update

Zacks

Generic competition has adversely impacted AstraZeneca's (AZN) 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 genericization.

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 Roche (RHHBY), Novo Nordisk (NVO) and Bayer (BAYRY) look well-positioned. While Roche is a Zacks Ranked #1 (Strong Buy) stock, Novo Nordisk and Bayer carry a Zacks Rank #2 (Buy).

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