AstraZeneca plc AZN announced disappointing top-line data from the SOCRATES study on its heart drug Brilinta/Brilique (ticagrelor). The study evaluated the efficacy and safety of Brilinta (90 mg, twice daily) compared to aspirin (100 mg, once daily) for the prevention of acute ischemic stroke or transient ischemic attack in patients over 40 years of age.
Results showed that the study failed to meet the primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischemic or hemorrhagic), myocardial infarction (known as heart attack) and death. Though fewer events were observed in patients on Brilinta versus the comparator in the overall study population, the trend did not achieve statistical significance.
Based on preliminary analyses, however, safety data was found to be consistent with the known safety profile of Brilinta. The company plans to present the full analysis of study results including subgroups at an upcoming stroke congress. It also intends to discuss with regulatory agencies regarding the interpretation of the data.
We note that Brilinta is one of the key products in the company’s portfolio and is also identified as one of the six growth platforms of the company. In 2015, Brilinta registered sales of $619 million, reflecting an increase of 44% at constant exchange rate.
Given that the company is working to drive Brilinta sales by expanding the drug's label, the latest development is discouraging.
Apart from SOCRATES, some of the other ongoing studies on Brilinta include EUCLID (peripheral arterial disease) and THEMIS (patients with type II diabetes at high risk of cardiovascular events) among others. Data from the EUCLID study is expected in the second half of 2016. We note that all these studies including SOCRATES are part of the company’s PARTHENON – cardiovascular outcomes program on Brilinta.
AstraZeneca is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF, Anika Therapeutics Inc. ANIK and AMAG Pharmaceuticals, Inc. AMAG. All three stocks carry a Zacks Rank #1 (Strong Buy).
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