AUXL's Xiaflex Decision Delayed - Analyst Blog

By
A A A

Auxilium Pharmaceuticals, Inc. ( AUXL ) recently announced a three-month delay in the Prescription Drug User Fee Act (PDUFA) goal date for its supplemental biologics license application (sBLA) for Xiaflex.

Xiaflex (in-licensed from BioSpecifics Technologies Corp. ( BSTC )) is an injectable enzyme (clostridial collagenase for injection) that is currently approved for the treatment of Dupuytren's Contracture. Auxilium Pharma is looking to get Xiaflex' label expanded into the treatment of Peyronie's disease.

The FDA was initially supposed to deliver a decision regarding the label expansion by Sep 6. However, during the process of label discussions with the FDA, Auxilium Pharma made revisions in its proposed Risk Evaluation and Mitigation Strategy (REMS) program as well as aspects related to the proposed label. The FDA is treating the submitted revisions as a major amendment and has, therefore, extended the review period to Dec 6. Importantly, the FDA has not asked Auxilium Pharma to conduct additional studies.

The extension of the review period is disappointing, though not a setback, as the FDA has not asked for additional studies to be conducted during this period. Expansion into the Peyronie's indication would boost Xiaflex sales.

Auxilium Pharma has collaboration agreements with Japan's Asahi Kasei Pharma Corporation, Swiss biopharma company, Actelion ( ALIOF ) and Swedish Orphan Biovitrum AB for the development, supply and commercialization of Xiaflex (EU trade name: Xiapex) in different territories.

Xiaflex is also being evaluated for the treatment of adhesive capsulitis (frozen shoulder syndrome), with a late-stage study expected to commence in the fourth quarter of 2013, and the treatment of edematous fibrosclerotic panniculopathy with a phase IIa study slated to commence later this year.

Auxilium Pharma currently carries a Zacks Rank #3 (Hold). At present, BioSpecifics, Questcor Pharmaceuticals, Inc. ( QCOR ) and Actelion look well-positioned with all three being Zacks Rank #1 (Strong Buy) stocks.



ACTELION LTD (ALIOF): Get Free Report

AUXILIUM PHARMA (AUXL): Free Stock Analysis Report

BIOSPECIFICS TE (BSTC): Get Free Report

QUESTCOR PHARMA (QCOR): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research



The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALIOF , AUXL , BSTC , QCOR

Zacks.com

Zacks.com

More from Zacks.com:

Related Videos

Stocks

Referenced

Most Active by Volume

75,031,044
  • $16.26 ▲ 0.31%
64,683,841
  • $99.76 ▲ 2.14%
44,561,744
  • $14 ▼ 6.23%
37,984,130
  • $27.93 ▲ 0.36%
36,148,020
  • $94.39 ▲ 1.49%
33,981,456
  • $22.93 ▼ 1.38%
33,971,527
  • $44.08 ▲ 1.03%
33,685,322
  • $76.95 ▲ 1.32%
As of 10/20/2014, 04:15 PM

Find a Credit Card

Select a credit card product by:
Select an offer:
Search
Data Provided by BankRate.com