FDA, Clinical Trial Calendar Updates: CTIC, CYPB, DNDN, FRX, MRK

Written by Mike Havrilla

Tuesday, 21 April 2009 02:15

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.) Forest Labs (FRX) and Cypress Bioscience (CYPB) announced yesterday that Savella (milnacipran) will be shipped to wholesalers on April 24th and will be available at pharmacies beginning on April 28th. After Savella was approved by the FDA in mid-January, the companies submitted a minor post-approval cosmetic formulation change to the FDA which now has been approved.

Savella was approved for the management of fibromyalgia, which is a chronic condition characterized by widespread pain and decreased physical function that affects as many as six million people in the United States. Savella will be marketed by FRX and its licensor, CYPB. Pierre Fabre, who originally developed and sells milnacipran outside of the U.S., has licensed the rights to Savella in North America to CYPB.

2.) Merck (MRK): Actelion (ALIOF.PK) announced today that it has discontinued the development in partnership with MRK of an early stage compound (classified as a renin inhibitor) for the treatment of high blood pressure due to poor results from several clinical trials. The companies will focus on similar compounds in early stages of development for the same indication.

3.) Cell Therapeutics (CTIC): CTIC recently presented data from a preclinical study that identifies genetic markers for an enhanced anti-cancer effect for brostallicin, which is currently in Phase 2 clinical development as a new type of synthetic cancer drug (a DNA minor groove binding agent) and has the potential to be a highly selective cancer treatment that is synergistic with standard chemo drugs and newer targeted therapies. CTIC owns the exclusive, worldwide rights to brostallicin and has completed six clinical trials for the drug, with results for three of the trials still pending.

CTIC has agreements with Novartis (NVS) for both pixantrone and Opaxio which provide for $17.5M in potential pixantrone milestone payments ($7.5M licensing option for NVS + $10M approval milestone payment for pixantrone) and $25M for an Opaxio approval milestone in Europe. The Company expects to receive an opinion on the Marketing Authorization Application for Opaxio in Europe during 2H09 and recently initiated a rolling NDA submission with the FDA for pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). CTIC expects to complete the submission during 2Q09 and will request a priority review (six month) that could lead to an approval decision from the FDA before year-end.

4.) Dendreon (DNDN) announced the initiation of a Phase 1 clinical trial today evaluating D3263 as a small molecule compound for the treatment of solid tumors which are refractory to standard treatments. The early stage trial will evaluate safety as the primary endpoint, but will also examine the anti-cancer effect of the compound and dosing parameters. More information for patients who are interested in the trial is available by searching for 'D3263' at www.clinicaltrials.gov.

Disclosure: No positions.

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