FDA and Clinical Trial Updates: ADLS, CLDA, GENZ, ISTA, Theratech

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.

Advanced Life Sciences Cethromycin NDA (once-daily antibiotic for the treatment of community acquired pneumonia - CAP) is pending with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

Clinical Data (CLDA) announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase 3 trial. Clinical Data intends to file these data as the second of two positive registration studies in support of a New Drug Application (NDA) with the FDA for vilazodone for the treatment of MDD by the end of 2009.

On 6/2/09, Israel-based Kamada Ltd. (KAMAF.PK) announced that it has submitted a Biologics License Application (BLA) to the FDA for its lead clinical candidate, intravenous alpha-1 antitrypsin (AAT-IV), for the treatment of Alpha-1 Antitrypsin Deficiency. Kamada has developed a unique, high purity, liquid, ready-to-use human plasma derived AAT indicated for the treatment of Alpha 1 Deficiency. The product is produced using a sophisticated, chromatographic purification method. The estimated PDUFA decision date is 4/2/10 for a standard, 10-month review by the FDA.

On 6/2/09 Genzyme (GENZ) announced a deal with Bayer HealthCare to acquire the worldwide rights to Campath/MabCampath (alemtuzumab), giving GENZ primary responsibility for the development and commercialization, including two rapidly progressing Phase 3 studies of alemtuzumab in relapsing-remitting multiple sclerosis (MS) patients. The first trial, for which enrollment is complete, treats early, active relapsing-remitting patients who have received no prior therapy. The second study, which is expected to complete enrollment before the end of 2009, is studying relapsing-remitting patients who had active disease while on other MS therapies. Data from the trials are expected to be available in 2011, and approval is anticipated in 2012.

ISTA Pharma (ISTA): On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) on June 26, 2009. Last November, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09 for the FDA to complete its review of the pending NDA.

On 6/1/09, Theratechnologies (THTCF.PK) announced that it filed a NDA with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence.

Disclosure: No positions.

Comments

[JOEMILLER:]

how can i find these kind of information which company submitted NDA or BLA and when FDA will review it.

Jun 03 02:29 PM