Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

The effectiveness of Merck’s (MRK) cholesterol lowering drug Zetia has been put to question following the release of data from a clinical trial comparing Abbott’s (ABT) Niaspan (niacin extended-release tablets) plus a statin with Merck’s Zetia. Although data are not encouraging for Merck, the company expressed its confidence recently at the American Heart Association meeting.

Results from the ARBITER 6 - HALTS study showed that patients at high cardiovascular risk showed significant reduction in atherosclerosis after 8 and 14 months of therapy with Abbott's Niaspan plus a statin, the study's primary endpoint. The study met its secondary endpoint too. It was observed that treatment with Niaspan plus statin resulted in significantly fewer major adverse cardiac events (or MACE, a composite endpoint consisting of heart attack, myocardial revascularization, admission to the hospital for an acute coronary syndrome, and death from coronary heart disease), as compared to Zetia. However, the

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AstraZeneca (AZN) recently said that results from a phase III head-to-head trial showed that its Brilinta (ticagrelor) achieved greater efficacy in the primary endpoint, reduction of cardiovascular events, compared to Sanofi-Aventis/Bristol-Myers’ (SNY/BMY) Plavix (clopidogrel).

Brilinta significantly reduced the mortality rate from cardiovascular events, myocardial infarctions and strokes without increasing major bleeding, which is a side-effect of Plavix. However, the frequently reported side-effects of Brilinta included slower heart rhythms and dyspnoea.

Brilinta is an investigational oral anti-platelet treatment being developed for acute coronary syndrome (ACS). Results from the 18,624 patient PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial were presented at the European Society of Cardiology congress and published in the New England Journal of Medicine (NEJM).

The data on Brilinta look compelling and could help the product gain market share from Plavix once launched. Sanofi-Aventis recorded 2.6 billion Euros from Plavix sales last year,

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For Immediate Release

Chicago, IL - May 12, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Tekelec Inc. (TKLC), AstraZeneca (AZN), Precision Castparts Corp. (PCP), Teva Pharmaceuticals, Inc. (TEVA) and Agrium Inc. (AGU).

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Here are highlights from Monday's Analyst Blog:

Tekelec Valuation Raised

We maintain our Buy rating with a higher valuation target for Tekelec Inc. (TKLC), a leading provider of signaling and performance solutions. This follows first quarter 2009 financial results which were better than our estimates. We believe the company may

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Highlights include AstraZeneca plc (AZN), Bristol-Myers Squibb Company (BMY), Sanofi-Aventis SA (SNY) and Eli Lilly and Company (LLY).Brilinta Not AstraZeneca's PanaceaThis morning, AstraZeneca (AZN) announced positive top-line results of its phase III 18,600-patient PLATO trial, comparing AZN's Brilinta (ticagrelor) with Plavix (clopidogrel) in the reduction of cardiovascular events in patients with acute coronary syndrome (i.e. - at-risk of cardiovascular events).The company announced that Brilinta met the primary endpoint in the trial, a statistically significant difference in time to occurrence of any event of the composite endpoint of myocardial infarction, stroke or cardiovascular death. Safety was comparable to what was observed in phase II trials.The full-results of the trial are expected to be presented at the annual European Society of Cardiology meeting in August. AstraZeneca expects to submit Brilinta for FDA approval in the fourth quarter 2009, potentially ...

Highlights include Sanofi-Aventis SA (SNY) and Johnson & Johnson (JNJ).On March 18th and 19th, the FDA advisory panels recommended approval of 2 important cardiovascular product candidates. The FDA does not have to follow the recommendations of the panels but usually does.On Wednesday, the 18th of March, an FDA advisory panel recommended approval of Sanofi-Aventis' (SNY) heart drug Multaq. Multaq (dronedarone) is a new class III anti-arrhythmic drug developed for atrial fibrillation (AF).On Thursday the 19th, an FDA review panel voted 15 to 2 in favor of approving Johnson & Johnson's (JNJ) anticoagulant rivaroxaban. Rivaroxaban, which will be sold under the brand name Xarelto upon approval, will be marketed in the U.S. by J&J and is already sold partner Bayer AG outside of the U.S. Multaq was initially submitted to the FDA for approval in 2006 but the FDA responded ...