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 ...

GlaxoSmithKline (GSK) and Nabi Biopharmaceuticals (NABI) signed a licensing agreement for a nicotine conjugate vaccine (NicVAX) as well as for the development of a second generation nicotine vaccine. NicVAX is an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse. Earlier in October, the vaccine received a $10 million grant from the National Institute on Drug Abuse.

As per the agreement, Nabi will get an upfront payment of $40 million and is eligible to receive more than $500 million (together with upfront payment) as option fees and milestones for the vaccine, NicVAX, and follow-on nicotine vaccines. Nabi has the potential to receive double-digit royalties from sales if the product is commercialized. GlaxoSmithKline will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-generation nicotine vaccines using Nabi's intellectual property together with GSK's own technology.

NicVAX is currently

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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 ...

Santarus, Inc. (SNTS) reported third-quarter earnings of 9 cents per share, surpassing the Zacks Consensus Estimate at a loss of 1 cent and the year-ago loss of 8 cents. Total revenues, consisting of net product sales, promotion revenues, and license and royalty revenues, came in at $39.5 million, up 22% from the year-ago period.

Product-related revenues, which consist of net product sales and promotion revenues, increased 30% to $38.3 million in the third quarter of 2009. Zegerid net product sales were $31.5 million, up 12%. Total prescriptions increased 6.3% in the reported quarter. Competition in the proton pump inhibitor (PPI) market is likely to increase with the launch of generic versions of Prevacid and an over-the-counter version of Prevacid.

Promotion revenues of $6.8 million increased significantly from the prior-year period's promotion revenues of $1.4 million, mainly due to revenues associated with the promotion of Glumetza. Glumetza total prescriptions increased 9.2%

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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 ...

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Amylin (NasdaqGS:AMLN) based in San Diego, said late Sunday it will receive $75 million upfront from Takeda and said future payments for development and achieving commercial milestones could top $1 billion. The deal includes two potential weight-loss treatments, a pramlintide-metreleptin combination and davalintide. Both potential drugs are in midstage, or Phase II, clinical development. In July, Amylin said pramlintide-metreleptin prompted an average weight loss of 22 pounds, or 11 percent of patients’ body weight, during a midstage study.

Human Genome Sciences Inc (NasdaqGM:HGSI) and GlaxoSmithKline (NYSE: GSK) said Monday heir experimental

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GlaxoSmithKline (GSK) and Denmark-based Genmab received some good news with the US Food and Drug Administration’s (FDA) approval for Arzerra (ofatumumab), a monoclonal antibody for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.  Arzerra is approved for cancer patients who are no longer responding to the current available treatment options using fludarabine and alemtuzumab. Following the approval, Genmab has become eligible to receive a milestone payment of DKK 116 million (approximately $23 million) from Glaxo.  Earlier, in May 2009, Arzerra had received a positive recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) in which the panel had voted 10-3 in favor of the drug. They had found that Arzerra provided some clinical benefit to patients with CLL whose disease was refractory to fludarabine and alemtuzumab.  Arzerra has been approved by the FDA under the accelerated approval process ...

McKesson Corp. (MCK) reported its fiscal second-quarter earnings of $1.07 per share, beating the Zacks Consensus Estimate of $1.01. However, earnings declined from the year-ago profit of $1.17. Meanwhile, revenues increased 1.9% to $27.1 billion.   The Distribution Solutions segment grew 2% with the U.S. pharmaceutical distribution business recording a 2% increase in revenues. The loss of two customer buying groups in the U.S. continued to impact the performance of this segment. We believe the performance of the Distribution Solutions segment will continue to be impacted by the lost business through the remainder of the year.   Canadian revenues grew 9% as the Canadian pharmaceutical market remained slightly stronger than the U.S. market. Medical-Surgical distribution revenues also increased (up 5%), benefiting from small acquisitions made by the company in late fiscal 2009. The Specialty Care Solutions business performed well, benefiting from the launch of generic versions of Oxaliplatin....

Theravance (THRX) announced its third quarter results after the closing bell yesterday. The company’s loss per share came in at 35 cents, a penny wider than the Zacks Consensus Estimate. It had earned 34 cents per share in the year-ago period. Revenues were $5.5 million during the quarter, compared with $6 million in prior-year quarter. Theravance receives revenues in the form of milestone payments from its collaborating partners including GlaxoSmithKline (GSK) and Astellas Pharma.   Operating expenses remained unchanged at $26.6 million. While R&D expenses declined 2.6% due to lower costs related to the regulatory process for telavancin (Vibativ), G&A expenses increased 8.7% due to higher employee related costs.

The reported quarter had been quite significant for Theravance with the company receiving US Food and Drug Administration (FDA) approval for its long awaited product Vibativ for the treatment of complicated skin and skin structure infections (cSSSI) caused by

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Vimovo Demonstrates Benefit Over Naproxen Yesterday, at the American College of Gastroenterology meeting in San Diego, Pozen (POZN) released data from two phase III trials comparing Vimovo (formerly PN400) to enteric-coasted naproxen (ECN) in patients with osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) who are at risk of developing NSAID-associated gastric ulcers. The data demonstrated that patients taking Vimovo experienced significantly greater reduction in severity of dyspepsia (SODA) and overall treatment evaluation for dyspepsia (OTE-DP) compared to patients taking ECN. The OTE-DP results showed 43-46% of the patients on Vimovo reporting positive change at month six vs. only 28-34% on ECN. The results were highly statistically significant. Plus, patients taking Vimovo also had discontinuation rates far below ECN, at 3-5% vs. 11-12%, respectively. The safety of Vimovo was also superior to ECN, with only 2% of the patients experiencing erosive duodenitis as compared to 10-14% for ...