AstraZeneca’s (AZN) blood-thinner Brilinta is available for reducing cardiovascular death and heart attack in patients suffering from acute coronary syndrome (ACS) since 2011. The U.S. Food and Drug Administration approved the drug on the basis of the PLATO study, which compared Brilinta to Bristol-Myers Squibb & Co./Sanofi’s (BMY/SNY) Plavix (clopidogrel) in 18,624 patients suffering from ACS.
A significantly greater reduction in the primary end point (a composite of cardiovascular death, myocardial infarction and stroke) was observed in patients receiving Brilinta as compared to patients on Plavix.
We note that in its third quarter 2013 earnings press release, the company disclosed that the U.S. Department of Justice (DOJ), Civil Division has raised a civil investigative demand regarding the PLATO study in Oct 2013. Although no further details were divulged, AstraZeneca said that it intends to cooperate with the inquiry.
Meanwhile, AstraZeneca has announced its plan to initiate two new studies (SOCRATES, n = 9,600, and THEMIS, n =17,000) on Brilinta. While SOCRATES will compare the use of Brilinta for the prevention of major vascular events in patients with acute ischemic stroke or transient ischemic attack with aspirin, THEMIS will evaluate Brilinta for the long-term prevention of major vascular events in patients suffering from type II diabetes at high cardiovascular risk.
Both SOCRATES and THEMIS will be monitored and reviewed by the Independent Data Monitoring Committee.
Brilinta is one of the key new products for the company. In the third quarter of 2013, Brilinta sales were $75 million compared with $65 million in the preceding quarter. The company is working on driving Brilinta sales.
AstraZeneca carries a Zacks Rank #3 (Hold). Generic competition has adversely impacted AstraZeneca’s revenues over the past few quarters. This has put significant pressure on the company. AstraZeneca is looking toward cost-cutting initiatives to drive the bottom line in the face of genericization.
Right now, Johnson & Johnson (JNJ) looks attractive. The stock carries a Zacks Rank #2 (Buy).
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