POZN (10.87)..The coming weeks are going to be busy for the FDA, which has a packed schedule. Let's take a look at the companies awaiting FDA decision this week.
The decision whether or not to approve Pozen Inc.'s ( POZN | Quote | Chart | News | PowerRating) Vimovo, an investigational drug for the treatment of signs and symptoms of osteoarthritis , rheumatoid arthritis and ankylosing spondylitis in patients who are at risk of developing *NSAID-associated gastric ulcers, will be issued by April 30. (*Non-steroidal Anti-inflammatory Drugs)
Vimovo is developed in partnership with AstraZeneca plc (AZN). The New Drug Application for Vimovo was submitted on June 30, 2009, and based on a standard 10-month review, the FDA decision date is April 30, 2010. Pozen's partner AstraZeneca is seeking approval of Vimovo in the European Union too.
Pozen, which has thus far received $80 million in upfront and milestone payments from AstraZeneca, is eligible to earn $20 million in milestone payment if Vimovo wins regulatory approval in the U.S. and another $25 million if the drugs gets approved outside of the U.S. Based on achievement of certain sales thresholds, Pozen is also entitled to receive sales performance milestones of $260 million.
Pozen shares, which have gained over 70% in the past three months, closed Friday's trading at $10.87 on a volume of 1.07 million shares.
Sepracor Inc. , which was acquired by Japanese drug maker Dainippon Sumitomo Pharma Co., late last year, is yet another company, which faces the FDA decision by April 30 , and waiting at the altar is the company's potential epilepsy drug Stedesa.
According to the company, clinical studies have indicated that Stedesa has the potential to reduce seizure frequency, provide simpler dosage titration and reduce side effects with once-daily dosing.
Stedesa, which is known by the brand name Zebinix in the E.U., was approved there for the treatment of patients with partial-onset seizures last April.
Dendreon Corp. ( DNDN | Quote | Chart | News | PowerRating) , a classic example of a company, which has exhibited a steely determination to bring its drug to market, despite several regulatory setbacks, will get to hear the FDA's final decision on its investigational prostate cancer vaccine Provenge on May 1.
Provenge, an investigational vaccine for the treatment of prostate cancer, works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and attacks the cancer cells.
This is Provenge's second go-around with the FDA. Earlier, Dendreon filed for approval of Provenge in 2007 and an FDA Advisory Committee voted 17-0 in favor of the prostate cancer vaccine's safety and 13-4 that it demonstrated "substantial efficacy." That the FDA did not approve Provenge despite the advisory panel's favorable votes and requested more data is now part of the Dendreon story.
Dendreon filed its amended application with the FDA seeking approval of Provenge on November 2, 2009 and is now looking forward to the big decision from the FDA.
DNDN has risen nearly 40% in the past three months. The stock closed Friday's trading at $40.10 on a volume of 2.9 million shares.
Bristol-Myers Squibb's ( BMY | Quote | Chart | News | PowerRating) investigational drug to prevent graft rejection in kidney transplant recipients - Belatacept, faces final FDA decision on May 1.
On March 1, an FDA panel had voted 13 to 5, recommending approval of Belatacept. It is not mandatory for the FDA to follow the panels' advice, but usually does so.
Astella Pharma Inc.'s (ALPMF.PK) Prograf and Swiss drug giant Roche's Cellcept are the widely used transplant drugs. Prograf lost patent protection in the U.S. in April 2008, while Cellcept's patent expired in the U.S. in May 2009. The patent covering Belatacept expires in 2022 in the U.S.
Bristol-Myers is set to face the impact of generic intrusion in 2012 when its blockbuster blood-thinner drug Plavix goes off patent. Plavix is manufactured by Sanofi-Aventis (SNY) and marketed by Bristol-Myers.
The final patent on Plavix expires in November 2011 and its market exclusivity in the U.S. is expected to extend into 2012. According to IMS Health, worldwide sales of Plavix in 2009 was $6.6 billion.
Effective May 4, Lamberto Andreotti, will take over the reins as Bristol-Myers' CEO replacing James Cornelius, who is retiring. However, Cornelius will remain as chairman of the company.
BMY closed Friday's trading at $24.74 on a volume of 13.67 million shares.
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