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FDA Calendar Updates for Wyeth (NYSE:WYE), Isis Pharma (NASDAQ:ISIS) and others


Pasadena, CA, United States, 05/08/2009 - There are new updates to the database of over 200 entries included in the FDA and Clinical Trial Calendars.

Wyeth (NYSE:WYE), Pfizer (NYSE:PFE): WYE announced that the FDA granted a priority (six-month) review for the Company’s pending BLA for Prevnar (Pneumococcal 13-valent Conjugate Vaccine) which was filed at the end of March.

Savient Pharma (NASDAQ: SVNT): SVNT announced that its pending BLA for Krystexxa (pegloticase), a novel biological drug for treatment failure gout patients, will be reviewed by an Arthritis Advisory Committee appointed by the FDA on 6/16/09.

Amarin Corp. (NASDAQ:AMRN): AMRN announced today that it has agreed to a Special Protocol Assessment (SPA) with the FDA for its planned Phase 3 registration clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia (very high triglyceride levels).

Salix Pharma (NASDAQ: SLXP): Salix provided an update on the pending NDA for Sanvar (vapreotide), which is scheduled for a FDA Panel Review on 5/19/09 (the Gastrointestinal Drugs Advisory Committee).

Isis Pharma (NASDAQ:ISIS), Genzyme (NASDAQ:GENZ): Topline data is expected during 2Q09 from a Phase 3 clinical trial of mipomersen in the treatment of a genetic disorder (homozygous familial hypercholesterolemia) causing very high levels of LDL cholesterol (LDL-C).

Somaxon Pharma (NASDAQ:SOMX): SOMX provided clarity on the Complete Response Letter from 2/25/09 (CRL) for its experimental insomnia drug Silenor. Following recent discussions with the FDA, SOMX expects to submit additional analyses during 2Q09 from its adult sleep maintenance clinical trial along with other important information that the Company believes can support a decision by the FDA on the CRL.

Disclosure: No positions.

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