FDA, Clinical Trial Calendar Updates: WYE, SVNT, AMRN, ISIS, SLXP, SOMX Print E-mail
Thursday, 07 May 2009 17:04

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

1.) Wyeth (NYSE:WYE), Pfizer (NYSE:PFE): WYE announced today 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. The proposed indication in the U.S. for Prevnar 13 is for the prevention of invasive pneumococcal disease (IPD) and otitis media (ear infections) caused by the 13 serotypes included in the investigational vaccine in children aged two months through five years. Prevnar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

2.) Savient Pharma (NASDAQ: SVNT): SVNT announced today 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. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA in January to further strengthen and clarify the overall filing. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.

3.) 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). The SPA is a written agreement with the FDA regarding the design, endpoints, and planned statistical analysis of the Phase 3 trial to be used in support of a New Drug Application (NDA).

Pursuant to the SPA, the Phase 3 trial will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of two doses of AMR101, a prescription grade Omega-3 fatty acid, in patients with fasting triglyceride levels of ≥500 mg/dL (the AMR101 MARINE Study). The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period.

The trial is expected to enroll approximately 240 patients, with enrolment planned to commence in mid-2009. The trial will be conducted in centers throughout North and Central America, Europe, India and

South Africa. The Company plans to use the results of this Phase 3 registration trial as the basis for the submission of an NDA to the FDA. In addition to the AMR101 MARINE study, Amarin is also planning to conduct a Phase 3 trial with AMR101 in patients with high triglyceride levels (≥200 mg/dL and ≤500 mg/dL) who are on statin therapy (e.g. Lipitor, Crestor, Zocor).

4.) Salix Pharma (NASDAQ: SLXP): Salix provided an update earlier this week on the pending NDA for Sanvar (vapreotide), which is scheduled for a FDA Panel Review on 5/19/09 (the Gastrointestinal Drugs Advisory Committee). Salix is the U.S. marketing partner for Swiss-based Debiopharm, which filed its complete response to the FDA on 11/4/08 in response to an approvable letter for Sanvar. The immediate release formulation of Sanvar, a somatostatin analogue, is used in the treatment of a condition known as acute esophageal variceal (veins) bleeding.

5.) 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). A NDA filing with the FDA is expected 2H10 by partner GENZ, pending results of the study which is designed to show that mipomersen can reduce LDL-C levels by at least 20% versus placebo among patients who are high dose statin therapy.

6.) Somaxon Pharma (NASDAQ:SOMX): SOMX provided clarity today 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. SOMX intends to raise cash to fund operations through the FDA review period for Silenor.

Disclosure: No positions.

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