Wednesday, 23 October 2013

Upcoming FDA PDUFA: Auxilium Pharmaceuticals + Biospecifics Technologies - Xiaflex (collagenase clostridium histolyticum) - Peyronie's Disease

Auxilium Pharmaceuticals and Biospecifics Technologies announced a three-month FDA PDUFA date delay since the initial scheduled date of Sept 6, 2013. The next PDUFA date for Xiaflex's supplemental biologics license application (sBLA) for the treatment of Peyronie's disease is December 6, 2013. 

The delay was caused by the company, rather than by the FDA, and is related to changes made by Auxilium in relation to proposed Risk Evaluation and Mitigation Strategy (REMS) program and other aspects related to the proposed label. The changes were classified as a major amendment by the FDA, causing the delay in the scheduled PDUFA date. The FDA has not requested any additional clinical trials or information at this time. 

Date of FDA Decision (PDUFA): December 6, 2013
Company name: Auxilium Pharmaceuticals & Biospecifics Technologies
Stock tickerAUXL and BSTC
LocationMalvern, Pennsylvania
Type of applicationSupplemental BLA – novel indication
Name of drug: Xiaflex (Collagenase clostridium histolyticum)
Indication: Peyronie's Disease

23rd October 2013:
Auxilium Pharma:
Market Cap
$851.28 Mln
52-week range
13.87 – 21.60
Avg. volume

Q2 2013:
Net Income
$0.22 per share
$74.6 mln

Biospecifics Technologies:
Market Cap
$116.95 Mln
52-week range
12.52 - 19.99
Avg. volume

Q1 2013:
Net Income
$0.15 per share
$12.0 mln

Auxilium is an unmet niche specialist addressing rare and orphan diseases, mainly through biopharmaceuticals.  Auxilium has two products on the market and three currently in clinical development; all products in the Auxilium’s pipeline are for different indications of the same product – Xiaflex (collagenase clostridium histolyticum).

Auxilium Pharmaceuticals: Clinical Pipeline
Note: The Xiaflex Cellulite Study has recently entered phase 2a

Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum that dismantles collagen. It is marketed and is being developed as a local injection into areas with overly high collagen accumulation, such as in the case of Dupuytren’s disease (severely clenched fingers) and Peyronie’s disease (penile curvature)—a connective tissue disorder involving the growth of fibrous plaques in the soft tissue of the penis affecting up to 10% of men. According to Auxilium, 65,000 to 120,000 new patients are diagnosed with Peyronie’s disease each year. Peyronie’s disease causes pain, abnormal curvature, erectile dysfunction, indentation, loss of girth and shortening, with no effective treatment to date. Xiaflex has already demonstrated efficacy in treating Peyronie’s disease in clinical trials, and, if approved, will be the first non-surgical treatment for the indication.

In two 400-patient trials Xiaflex was injected into the penile plaque over a period of several months. The company reported in a press release that the treatment yielded a 37.6 reduction in penile curvature in one trial and a 30.5% reduction in the second. The average deformity of the penis at the beginning of the study was 48.8 degrees in men receiving the drug and 49 degrees in those receiving placebo. After 52 weeks, the deformity was only 31 degrees in men receiving Xiaflex and 39 degrees in those receiving placebo. Although the results are not overwhelming, Xiaflex is the only available treatment currently in the pipeline, thus an automatic improvement over what is currently available.

According to the Auxilium company website, "During the course of recent product label discussions, Auxilium submitted revisions regarding the Company's proposed Risk Evaluation and Mitigation Strategy (REMS) program and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date to December 6, 2013. The FDA has not requested that any additional clinical studies be performed prior to the revised PDUFA action date."

Xiaflex was developed by BioSpecifics Technologies, but its clinical trials were carried out by Auxilium. Along with Pfizer Auxilium is also responsible for Xiaflex’s marketing.

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