Recently, Bristol-Myers Squibb Co. (BMY) received approval from the U.S. Food and Drug Administration (FDA) to market Abilify (aripiprazole) for the treatment of irritability in pediatric patients having autistic disorder. Abilify can be used to treat children aged 6 to 17 years for symptoms of aggression toward others, deliberate self injury, temper tantrums and quick mood swings.  Bristol-Myers and Otsuka Pharmaceutical Co. jointly develop and distribute the drug in the U.S. and Europe. The FDA approval of Abilify for treating irritation in pediatric patients with autistic disorder is based on data from two eight-week late-stage studies in which Abilify significantly improved scores on the irritability subscale of the caregiver-rated Aberrant Behavior Checklist (ABC-I), compared to placebo.  The most common adverse affects were sedation, fatigue, vomiting, somnolence, tremor and pyrexia. However, the efficacy of Abilify for the maintenance treatment of irritability associated with autistic disorder was not ...

For Immediate Release

Chicago, IL – November 23, 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: Pozen (POZN), Sanofi-Aventis (SNY), Bristol-Myers (BMY), AstraZeneca (AZN) and ADC Telecommunications Inc. (ADCT).

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Here are highlights from Friday’s Analyst Blog:

Pozen Initiates New Phase III

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

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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 ...

Bristol-Myers Squibb Co. (BMY) intends to split its 83.1% holding in the Nutritional segment which operates under its subsidiary Mead Johnson and develops infant formulas such as Enfamil and other nutritional products. The move is aimed to enable the company to concentrate on its core biopharmaceutical business. The transaction is expected to be accretive to earnings beginning in 2010.  Under the terms of the deal, Bristol-Myers shareholders can exchange some, none or all of their shares of the company for shares of Mead Johnson common stock tax-free and at a discount. On completion, the exchange offer would enable Bristol-Myers to dispose of its entire holding interest in Mead Johnson.  For every $1 of Bristol-Myers stock exchanged, stockholders will get approximately $1.11 worth of Mead shares. The offer is set to expire on Dec 14, unless extended or terminated. Bristol-Myers owns 170 million shares of Mead Johnson. ...

For Immediate Release

Chicago, IL – November 10, 2009 – Zacks.com announces the latest Industry Outlook. Today, Zacks Equity Research discusses the Big Pharma & Biotech sector, including Alcon (ACL), Novartis (NVS), Gilead Sciences (GILD), Biogen Idec (BIIB) and Acorda Therapeutics (ACOR).

A synopsis of today’s Industry Outlook is presented below. The full article can be read at http://www.zacks.com/stock/news/27081/Big+Pharma+and+Biotech.

In the pharma space, we are positive on stocks like Alcon (ACL) and Novartis (NVS). We believe these companies will continue witnessing revenue growth based on continued international penetration, new product launches and market share expansion. Pipeline expansion through in-licensing deals and acquisitions should also add to growth.

Novartis should see strong vaccine sales this flu season. The company has received approval from the U.S. Food and Drug Administration for its swine flu vaccine, which

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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 ...

Today, Dainippon Sumitomo and Sepracor (SEPR) have announced the successful completion of the initial share offering period, where almost 78.2% of Sepracor’s shares were tendered. The offer period has been extended to Oct 19, 2009, to enable other shareholders to tender their shares as well.  As a reminder, in September, the Japanese pharmaceutical company Dainippon Sumitomo Pharma Co had announced a deal to acquire Sepracor at $23 per share or $2.6 billion. However, soon after the announcement, shareholders of Sepracor filed a suit in a Delaware court against the company, citing the offered price as inadequate. They were seeking the court’s intervention to stop the deal and pay damages.  Additionally, certain aspects of the deal were against the interest of Sepracor’s shareholders. The deal included a $77.4 million termination fee and a “no solicitation" provision. Apart from restricting the possibility of any superior proposal, these provisions ...

Yesterday, Novartis Pharma AG (NVS) signed an agreement with Vanda Pharmaceuticals Inc. for the acquisition of exclusive US and Canadian rights to Fanapt (iloperidone), an oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia.  Fanapt belongs to a new generation of schizophrenia drugs known as atypical antipsychotics. In addition to gaining exclusive commercialization rights to the oral formulation of Fanapt in the US and Canada, Novartis will also have exclusive rights to develop and commercialize a long-acting injectable (or depot) formulation of the medicine for these markets.  Vanda will receive an upfront payment of $200 million from Novartis. Besides this, the company will receive additional payments based on the achievement of defined development and commercial milestones. Vanda will also receive royalties on product sales. Vanda has retained rights to develop and commercialize Fanapt outside ...

• Wynn (NASDAQ:WYNN) IPO, representing a 25% stake in Wynn's Macau operations, priced its $1.6 billion listing at the high end of the projected range

• Deutsche Bank (NYSE:DB) raised its price targets on numerous applications software firms, noting positive signs for the second half. Included in this group were: Adobe (NASDAQ:ADBE) with its target lifted to $22 from $20; Oracle (NASDAQ:ORCL) hiked to $44 from $40; and Salesforce.com (NYSE:CRM) raised to $80 from $65

• Bristol-Myers-Squibb (NYSE:BMY) coverage was initiated by Wells Fargo (NYSE:WFC) with "outperform," rating noting that, "strategic repositioning ahead of patent cliff, new product flow between 2009-2012, broadening R&D portfolio through selective risk-sharing, and high dividend yield underlie our positive thesis"

• Wells Fargo (NYSE:WFC) initiated coverage of Eli Lilly (NYSE:LLY) with "market perform," and with a $33-$35 valuation, noting concerns over a "steep and lengthy patent cliff and recent clinical setbacks."  The firm cautioned its Alzheimer's program and the Imclone pipeline "do

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