St. Jude Medical, Inc. (STJ) today reported financial results for the third quarter of 2009 before the market opened. Earnings per share came in at 59 cents, compared to the Zacks Consensus Estimate of 58 cents and the year-ago earnings of 54 cents. Sales Net sales in the reported quarter increased 7% year over year to approximately $1.2 billion. Excluding an unfavorable foreign exchange translation (FX), net sales increased 10% year over year. Growth was witnessed across all the business segments. However, the company’s domestic revenues were below expectation primarily due to lack of purchase of cardiac rhythm management (CRM) devices by roughly 50 hospitals in the U.S. In terms of business segments: CRM revenues increased 2% year over year to $690 million. Growth was led by higher demand for both implantable cardioverter defibrillator (ICD) and pacemaker. ICD revenues increased 2% year over year to ...

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 ...

St. Jude Medical Inc. (STJ) recently made a $15 million equity investment in Micell Technologies, a small company that operates in the niche market of developing drug-coated stents.

We view this as St. Jude’s strategy to acquire Micell in future and bolster its position in the cardiovascular segment. However, the investment does not give St. Jude a right to have a voting member in Micell’s board. Other details of the deal were not disclosed.

Micell’s drug-coated stents are less likely to produce blood clots than drug-eluting stents. A stent is a small metal tube used in surgeries to open up clogged arteries.

The equity investment provides Micell with a partner and funding source for exploring other applications in coating technology.

St. Jude Medical is a leading medical device manufacturer that designs, manufactures and distributes medical devices to treat cardiovascular and neurological conditions. The company operates through four business

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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

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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

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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 ...

On July 9, global research-driven pharmaceutical products company Merck & Co. Inc. (MRK) signed an agreement with privately owned Portola Pharmaceuticals Inc. for the development and marketing of a drug for prevention of strokes in patients with dangerous irregular heart rhythm (atrial fibrillation). The deal is worth up to $470 million.

The drug candidate, betrixaban, is currently undergoing phase II studies. Merck has agreed to undertake all costs relating to the development and commercialization of the drug. According to the American Heart Association, about 2.2 million Americans suffer from atrial fibrillation.

We believe the deal reinforces Merck’s already established pipeline which includes many cardiovascular drugs. The New Jersey-based company has a significant joint venture with another large pharmaceutical player Schering-Plough (SGP) for cardiovascular drugs Zetia and Vytorin.

However, we feel that this deal is a huge positive to Portola as it enables the California-based firm to be

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For Immediate Release

Chicago, IL - July 7, 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: CSX (CSX), Norfolk Southern (NSC), Burlington Northern (BNI), Union Pacific (UNP) and Sanofi-Aventis (SNY).

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:

Trainspotting

In looking for an economic recovery, one of the things to be looking at is rail traffic. While an increasing part of the economic output of the country (and the world) moves electronically, there is still a very important role for, to use a technical term, "stuff."

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Heart Drug Multaq Receives FDA approvalSanofi-Aventis (SNY) finally received some good news when the U.S. FDA approved the company's heart drug, Multaq, on July 2, 2009. Multaq provides patients suffering from atrial fibrillation (AF) or atrial flutter (AFL) with a new treatment option.The approval process for Multaq was not exactly smooth sailing with the company receiving a non-approvable letter from the FDA for its initial new drug application (NDA) filing in 2006. Sanofi resubmitted its NDA in 2008 and received a favorable response from an FDA advisory panel in March 2009.The product label will contain warnings regarding the use of the drug in patients with severe heart failure. However, Sanofi has a Risk Evaluation and Mitigation Strategy in place to ensure the product is used in the right patient base.According ...

St. Jude Medical (STJ) recently announced that two out of its 12 manufacturing facilities are presently under the FDA's (Food and Drug Administration) scrutiny as their manufacturing practices were not in conformity with the Current Good Manufacturing Practice.

The FDA has already issued a warning letter to St. Jude to state that it would neither grant the company's requests for export certificates to foreign countries, nor clear any pre-market approval applications for its class III devices until the violation is rectified.

The two facilities identified are Plano, Texas and Hackettstown, New Jersey. The company has already provided written responses to the FDA detailing proposed corrective actions at these facilities. The company needs to rectify the manufacturing practices faster to protect its top line.

St. Jude Medical is a leading medical device manufacturer that designs, manufactures and distributes medical devices to treat cardiovascular and neurological conditions. The

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