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 ...

Pfizer (PFE) announced that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products advisory committee voted in favor (10 to 1) of data presented to support the safety and effectiveness of Prevnar 13, its 13-valent pneumococcal conjugate candidate vaccine. The favorable recommendation of the vaccine was based on data from 13 phase III studies carried out on more than 7,000 children.  Pfizer is seeking FDA approval for the vaccine to prevent diseases (including sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema caused by 13 Streptococcus pneumoniae (S. pneumoniae) in infants and young children. Although the FDA is not required to follow the advisory panel’s recommendation, it generally does so. The FDA is reviewing the Biologic License Application (BLA) for Prevnar 13, which has an action date of December 30, 2009. Though the FDA was initially expected to respond by September 30, 2009, the agency had ...

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

...

Sanofi-Aventis (SNY) received good news earlier this week with the company receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Multaq. The CHMP recommended that Multaq should receive marketing authorization in the European Union.  The CHMP has recommended the approval of Multaq for use in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. The CHMP’s positive opinion is based on clinical data including results from seven international, multi-center, randomized clinical trials involving more than 7000 patients and including the landmark ATHENA trial.  Phase III results on Multaq showed that it, along with standard therapy, significantly reduced the risk of cardiovascular hospitalizations or death from any cause by 24% compared to placebo. This data should help Multaq gain share. We ...

On Friday, Wyeth Pharmaceuticals, a division of Wyeth (WYE), announced that the company's 13-valent pneumococcal conjugate vaccine for infants and toddlers received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).  The CHMP recommended the approval in children between 6 weeks to 5 years to protect them against 13 serotypes (forms), of a bacterium called streptococcus pneumoniae (pneumococcus) that can cause a series of diseases, ranging from ear infections to pneumonia and meningitis. The EMEA is expected to pass a final verdict on the matter in the coming months.  Prevenar 13 is a new form of Wyeth’s blockbuster pneumococcal 7-valent conjugate vaccine Prevnar which reported revenues of $2.7 billion in 2008. The 13-valent vaccine includes six new serotypes in addition to the seven included in Prevnar. It is estimated that Prevenar 13 would cover 92% of invasive pneumococcal ...

For Immediate Release

Chicago, IL – September 1, 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: Bayer AG (BAYRY), Bristol-Myers Squibb (BMY), Johnson and Johnson (JNJ), Sanofi-Aventis (SNY) and Pfizer (PFE).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513

Here are highlights from Monday’s Analyst Blog:

A Step Forward for Bayer

The therapeutic area of Atrial Fibrillation (AF) is buzzing with news. We are pleased with the development made by Bayer Schering Pharma, a division of Bayer AG (BAYRY) in this field. The company completed patient enrollment in the phase III study for Rivaroxaban

...

The therapeutic area of Atrial Fibrillation (AF) is buzzing with news. We are pleased with the development made by Bayer Schering Pharma, a division of Bayer Healthcare in this field. The company completed patient enrollment in the phase III study for Rivaroxaban (Xarelto). The study aims to assess the efficacy and safety of this drug against Bristol-Myers Squibb’s (BMY) warfarin, which is primarily used for the prevention of stroke in AF patients.

The study is expected to include about 14,269 patients spanning over 45 countries with results due by next year. Atrial fibrillation is the most common heart rhythm abnormality in the US. An estimated 3 million people in the US have atrial fibrillation, which affects about one in 10 people aged over 70.

Rivaroxaban, jointly developed with Johnson and Johnson (JNJ) is also being studied for the treatment of venous thromboembolism (VTE) and deep vein thrombosis (DVT) (apart from

...

div style="text-align: justify;"span style="font-weight: bold;"Genzyme (NASDAQ:GENZ)/span is getting some commentary this morning after the co disclosed on 8/28/09 that the European Medicines Agency (EMEA) issued a letter detailing one major observation and several other deficiencies at the Allston manufacturing facility.br /br /span style="font-weight: bold;"- Baird is downgrading GENZ to Neutral from Outperform /spanwhile lowering their target to $58 (prev. $64). Firm is lowering theior Cerezyme estimates considerably through 2012 as they now feel the odds of continued delays at Allston Landing and longer-lasting fallout from said delays are now higher. While continued snags with FDA’s review of Allston are one thing, now that EMEA has found issues at the plant, they are increasingly wary of further delay at this critical competitive juncture.br /br /span style="font-weight: bold;"EMEA’s turn./span GENZ indicated Friday that EMEA inspected Allston (August 17-21), finding one “major observation” and several other observations. GENZ will respond within 15-days.br /br ...

We are pleased to hear that the European Medicines Agency (EMEA) has agreed to review the Marketing Authorization Application (MAA) of Merck’s (MRK) vernakalant intravenous (IV). The company is seeking EMEA approval for the drug to address the unmet need for patients suffering from acute atrial fibrillation (AF, abnormal heart rhythms leading to strokes). Along with the IV version, Merck is also developing the oral form of the drug, which is currently in phase II development. In April 2009, Merck entered into a collaboration and licensing agreement with Cardiome Pharma Corp. in order to develop and commercialize vernakalant. While Merck retains the exclusive global rights to the oral formulation of vernakalant, its affiliate, MSD Switzerland GmbH gets the rights to the IV formulation outside the US, Canada and Mexico. Atrial fibrillation is the most common heart rhythm abnormality in the US, accounting for one out ...

Yesterday, Schering-Plough Corp. (SGP) revealed that the European Medicines Agency (EMA) will review its candidate for maintenance treatment of asthma in patients 12 years and above and an oral contraceptive for marketing in Europe. While the fixed-dose combination of mometasone furoate and formoterol fumarate for the maintenance treatment of asthma in patients 12 years and above is currently under review by the U.S. Food and Drug Administration (FDA), the filing for FDA approval of the contraceptive is expected in 2010. The oral contraceptive is a combination of a natural estrogen (which is identical to the estrogen produced by a woman's body) and a selective progestin. The drug was licensed from Merck KGaA. Schering is seeking marketing approval in Europe for the combination to prevent pregnancy. The approval of the combination of mometasone furoate and formoterol fumarate would further consolidate the company’s respiratory portfolio. Asthma, ...