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 ...

Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.  The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.  Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb's (BMY) Sinemet ...

GlaxoSmithKline, plc (GSK) reported third quarter income of 92 cents per American Depository Share (ADS), 3 cents below the Zacks Consensus Estimate. The company reported earnings of 94 cents in the year-ago period. Third quarter 2009 revenue increased 3%, with growth being driven by strong performances in emerging markets (up 25%), Japan (up 19%) and Consumer Healthcare (up 8%). We were pleased to see growth in Consumer Healthcare revenue despite the global slowdown. Meanwhile, US sales continued to be impacted by generic competition with revenue declining 12%. Sales of products like Imigran (down 74%), Lamictal (down 21%) and Requip (down 30%) and Wellbutrin XL (down 81%) kept declining. Pharmaceutical product revenue increased 2% with sales being driven by Advair/Seretide (up 5%) and Relenza. Relenza benefited from continued orders from several governments for stockpiling. Although vaccine sales were lower in the third quarter due ...

For Immediate Release

Chicago, IL – November 11, 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: Enzon (ENZN), Merck (MRK), OSI Pharmaceuticals (OSIP), Pfizer (PFE) and Bank of America Corporation (BAC).

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Here are highlights from Tuesday’s Analyst Blog:

Enzon Beats, Announces Sell-off

Enzon (ENZN) achieved break-even earnings during the third quarter of 2009, better than the Zacks Consensus Estimate of loss of 7 cents but below the year-ago earnings of 1 cent. The company reported revenues of $44.6 million, a decline of 9% compared to $48.8

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Enzon (ENZN) achieved break-even earnings during the third quarter of 2009, better than the Zacks Consensus Estimate of loss of 7 cents but below the year-ago earnings of 1 cent. The company reported revenues of $44.6 million, a decline of 9% compared to $48.8 million reported in the third quarter of 2008. Enzon records revenues from three sources -- products, royalties and contract manufacturing. The three segments recorded a decline of 1%, 6% and 56%, respectively, compared to the year-ago period. Enzon has four marketed products -- Oncaspar for the treatment of acute lymphoblastic leukemia (ALL); DepoCyt for lymphomatous meningitis; Abelcet for antifungal infection related to cancer and Adagen used to treat severe combined immunodeficiency disease (SCID), commonly known as the "bubble boy" disease. Apart from Oncaspar, whose sales remained unchanged from the year-ago period, the other three recorded a decline of 4%, 15% and 10%, ...

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 ...

Medivation Inc. (MDVN) has reported a net loss of 42 cents per share in the third quarter of 2009, exceeding the Zacks Consensus Estimate of a net loss of 39 cents. However, net loss declined from the year-ago loss of 68 cents.  Revenue for the quarter was $16.3 million, consisting of partial recognition of the non-refundable upfront payment of $225 million received from Pfizer (PFE) in October 2008. The upfront payment is being recognized on a straight-line basis through the first quarter of 2012. Revenues were nil in the year-ago period.  Operating expenses grew from $20.6 million in the year-ago period to $27.6 million in the quarter. Research and development expenses increased to $21.5 million as a result of greater clinical trials expenses which were partially offset by a cost share reimbursement under the company’s agreement with Pfizer. With Dimebon and MDV3100 moving into advanced ...

United Therapeutics Corporation (UTHR) reported a net income of 21 cents per share in the third quarter, well below the Zacks Consensus Estimate of 31 cents. The company reported earnings of 22 cents in the year-ago period. Even though revenues increased 29.6% to $97.2 million in the reported quarter, higher operating expenses led to the lower than expected net income.  The increase in revenues was primarily due to the continued increase in the number of patients being prescribed Remodulin and the recent launches of new products, Tyvaso and Adcirca. Net product sales, consisting of Remodulin, Tyvaso and Adcirca sales, increased 30.4% to $94.1 million. The company derives the majority of its product revenues from Remodulin, which posted sales of $87.4 million, up 21.3%.  Meanwhile, newly launched products, Tyvaso and Adcirca, contributed $5.1 million and $1.5 million, respectively, to total revenues. Both products should start contributing significantly ...

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, BioMarin Pharmaceutical Inc. (BMRN) announced that it has acquired the privately held Huxley Pharmaceuticals Inc., which possessed rights to a proprietary form of 3,4-diaminopyridine amifampridine phosphate ( 3,4-DAP), for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).   Under the terms of the transaction, BioMarin has already made an upfront payment of $15 million to Huxley shareholders and will pay an additional $7.5 million upon the final approval of amifampridine for LEMS from the European Commission (EC). The EC is expected to grant its approval in late 2009 or early 2010. Furthermore, Huxley stockholders would receive up to approximately $36 million in milestone payments if certain sales and U.S. development milestones are met.   BioMarin intends to launch amifampridine phosphate in Europe in the first quarter and is looking to develop an appropriate strategy for the drug in the U.S. Amifampridine phosphate will be the first drug ...