This morning, Pozen (POZN) initiated phase III studies on PA-325/40, a fixed-dose combination of 325mg enteric coated aspirin and 40mg of immediate release omeprazole. The phase III program will consist of two pivotal trials conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. FDA, and one long-term safety study. The two pivotal programs will enroll approximately 500 patients per study at over 100 sites around the U.S. The primary endpoint of the pivotal studies is the cumulative incidence of gastric ulcers over the six-month treatment period for PA32540 versus 325 mg of enteric-coated aspirin. The long-term study will enroll approximately 400 patients and assess safety over a period of one year. Pozen is developing PA-325/40 for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers. Aspirin is the No. 1 recommended agent for at-risk ...

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 ...

For Immediate Release

Chicago, IL – November 16, 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: GlaxoSmithKline plc (GSK), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN).

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Here are highlights from Friday’s Analyst Blog:

Glaxo H1N1 Vaccine Approved

GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This

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GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine.  The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.     The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is a part of the US Government’s intention to secure about 250 million doses to help fight the swine flu pandemic.   The current outbreak of swine flu pandemic can prove to be a big opportunity for vaccine manufacturers. In addition to Glaxo, other major players in this field include Sanofi-Aventis (SNY), Novartis ...

Biomagnetics Diagnostics Corp. is an advanced medical device and biotechnology company with a revolutionary diagnostics system and test kit testing technology for HIV, Hepatitis, H-Pylori, HPV, Tuberculosis and many other viruses, bacterium’s, toxins and diseases. The company focuses on real-time testing for the actual presence of the virus/ toxin/ disease itself, instead of the antibodies produced by the body’s immune system which may take anywhere from weeks to months to appear.

The company intends to follow the lead of established Western drugmakers and biotechs Merck & Co. (MRK), Wyeth (WYE), Eli Lilly & Co. (LLY), Schering-Plough (SGP), Novartis (NVS), Sanofi-Aventis (SNY), Genentech (DNA), Bristol Meyers Squibb (BMYS) and many others that are ramping up investments in China, India and Singapore. The company is currently working to establish a separate Chinese operating company that it intends to apply for listing on the Shenzhen or Hong Kong stock exchange.

Biomagnetics is also currently

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Regeneron Pharmaceuticals Inc. (REGN) reported a third-quarter net loss of $1.015 million, or 1 cent per share, which was much better than the Zacks Consensus Estimate of a loss of 23 cents. The company suffered a loss of $19.084 million or 24 cents in the year-ago quarter. The narrower loss reflected the increased contract research and development revenues from its collaborations with Sanofi-Aventis (SNY) and Bayer HealthCare, coupled with a milestone payment from Bayer. Total revenues for the quarter came in at $117.45 million from $65.58 million, up 79%. Total revenues consisted of contract research and development revenues, a 2009 research progress payment, technology licensing revenues apart from net product sales. Revenues from contract research and development increased 56% to $82.48 million from $52.88 million in the year-ago quarter. Contract research and development revenues relate primarily to Regeneron’s aflibercept and antibody collaborations with Sanofi-Aventis ...

The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses. According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic competition, including Lipitor, Plavix and Seretide. At the same time, new products are not expected to generate the same level of sales as the products losing patent protection have. With most of the big pharma companies already facing patent challenges for their blockbuster products or likely to face them going forward, the companies have been looking toward mergers ...

Micromet’s (MITI) third-quarter loss per share came in at 22 cents, well below the Zacks Consensus Estimate of 14 cents and a loss of 15 cents in the prior-year period. The company reported revenues of $4 million, compared to $7 million in the third quarter of 2008. Micromet records revenues primarily in the form of reimbursements of expenses incurred by the company under different collaborative agreements. We believe current investor focus is more on the developments of the company’s portfolio rather than the financials.

Operating expenses during the quarter increased 28% year over year to $17.13 million, primarily due to a 34% rise in R&D expenses. The increase in R&D expenses was driven by Micromet assuming full responsibility of the development of its lead candidate blinatumomab as per the company’s agreement with MedImmune.

As a reminder, earlier this month, Micromet had agreed to buy out MedImmune's option to reacquire the right

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Recently, Merck (MRK) and Schering-Plough (SGP) received approval from the US Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger. However, the transaction has yet to receive approval from other regulators, including China and Mexico. The deal was approved by the European Union antitrust regulators last week. Shareholders of both the companies have already approved the deal in August. Merck expects to close the proposed merger by year end. The FTC approval has come with the condition that both companies will sell some assets. As a result, Schering-Plough has agreed to sell its rolapitant drug, meant to be used for the treatment for nausea and vomiting in chemotherapy patients to Opko Health Inc. In addition, Merck agreed to sell its interest in Merial Ltd, an animal health joint venture, to its French partner, Sanofi-Aventis ...

Recently, the European Union (EU) approved the proposed $41.1 billion merger between Schering-Plough (SGP) and Merck & Co. (MRK). The deal is awaiting approval from the U.S. Federal Trade Commission. The transaction is expected to close in the fourth quarter of this year. While approving the merger, the EU clarified that the tie-up will not hinder effective competition significantly in Europe, even though both participants in the merger operate in the field of prescription pharmaceuticals. While checking for overlaps in Europe, particularly in the fields of asthma and allergic rhinitis, the European body did not find the products to be close competitors. Consequently, the merger would not be considered to hog the market and choke other companies. As a reminder, Merck filed for EU approval last month after the completion of the sale of its 50% interest in animal health company Merial Limited (Merial) to ...