October 2013 Urology Product Preview

PDUFA goal extended for Peyronie’s disease agent
The FDA said it is extending the Prescription Drug User Fee Act (PDUFA) goal date for Auxilium Pharmaceuticals’ supplemental biologics license application for collagenase clostridium histolyticum (XIAFLEX) for the treatment of Peyronie’s disease from Sept. 6, 2013 to Dec. 6, 2013.
During the course of recent product label discussions, Auxilium submitted revisions regarding its proposed Risk Evaluation and Mitigation Strategy program and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final 3 months of the review and extended the PDUFA goal date to Dec. 6, 2013. The FDA has not requested that any additional clinical studies be performed prior to the revised PDUFA action date, according to Auxilium.

Results: Test differentiates indolent from aggressive prostate cancer
Metamark Genetics, Inc. recently announced positive results from a large clinical validation study of ProMark, its biopsy-based prostate cancer prognostic test. The study met its primary endpoint demonstrating that ProMark, evaluated in standard formalin-fixed, paraffin-embedded prostate tissue, can differentiate indolent from aggressive disease. Based on the results, Metamark said it plans to make ProMark available to pathologists, urologists, and patients before the end of the year. Metamark’s positive, blinded clinical validation study follows three prior studies totaling over 1,250 patient cases, conducted by the company using its novel, automated, quantitative protein-based multiplex imaging platform.

FDA accepts complete response submission for T agent
The FDA has accepted for review the complete response submission made by Endo Pharmaceuticals, Inc. to the new drug application (NDA) for its long-acting testosterone undecanoate injection (Aveed), intended for men diagnosed with hypogonadism. In connection with the acceptance, the FDA assigned Endo’s application a new Prescription Drug User Fee Act action date of Feb. 28, 2014, according to Endo.
 

Safety Committee reports no concerns with BPH Tx
Nymox Pharmaceutical Corp. has reported favorable results from the most recent Safety Monitoring Committee periodic review of safety data for the company’s NX02-0018 clinical trial, one of two phase III pivotal trials for NX-1207, Nymox’s investigational drug for BPH. The Aug. 20, 2013 Safety Monitoring Committee meeting found no significant safety concerns to date. Both of the company’s pivotal phase III trials have completed enrollment and treatment (a single intraprostatic injection of either drug or placebo), and patient evaluation is continuing at over 70 sites across the U.S., according to Nymox.

VIVUS, Sanofi enter partnership for ED drug
VIVUS, Inc. has entered into a commercial supply agreement with Sanofi Chimie to manufacture and supply the active pharmaceutical ingredient (API) for avanafil (Stendra) on an exclusive basis in the U.S. and other territories and on a semi-exclusive basis in the European Union and Latin America. The companies had entered into a technology transfer agreement earlier in the year and have been actively working on the transfer of the avanafil API manufacturing process since that time. Pending completion of the transfer, VIVUS said it intends to submit amendments to the approved avanafil regulatory applications to the FDA and the European Medicines Agency to include Sanofi as a qualified supplier of avanafil API. The companies are also working on the qualification of Sanofi as a bulk tablet manufacturer for avanafil.

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