Auxilium Pharmaceuticals, Inc.
) received a huge boost recently with the company reporting
much-awaited positive phase III results on Xiaflex. The company
presented top-line results from the IMPRESS (The
tudies) trials which were conducted to evaluate Xiaflex for
While IMPRESS I saw Xiaflex patients experiencing a 37.6% mean
reduction in penile curvature deformity and a 44% improvement in
the Peyronie's Disease Questionnaire (PDQ) bother domain, IMPRESS
II saw Xiaflex patients experiencing a 30.5% mean improvement in
penile curvature deformity and 32.4% improvement in the PDQ bother
Auxilium Pharma intends to submit a supplemental Biologics
License Application (sBLA) by the end of 2012 seeking US Food and
Drug Administration (FDA) approval for the potential use of Xiaflex
in the treatment of Peyronie's.
Xiaflex is an injectable enzyme (clostridial collagenase for
injection) that is already marketed for the treatment of
Dupuytren's Contracture (DC), a condition that affects the
connective tissue in the palm known as palmar fascia.
Xiaflex is being studied for other indications as well including
the treatment of cellulite (edematous fibrosclerotic
panniculopathy) and the treatment of frozen shoulder syndrome.
Auxilium Pharma has a development, commercialization and supply
) for Xiapex (EU trade name of Xiaflex) for the treatment of
Dupuytren's and Peyronie's in Europe and certain Eurasian
countries. The company has agreements with Asahi Kasei Pharma
Corporation and Actelion for Xiaflex for other territories.
Auxilium Pharma will most likely succeed in gaining approval for
a second indication for Xiaflex. If all goes well, Xiaflex could be
on the market for the Peyronie's indication by late 2013.FDA
approval would make Xiaflex the first biologic therapy to be
approved for Peyronie's.
The company estimates that about 65,000-120,000 patients are
diagnosed with Peyonie's every year in the US with 5,000-6,500
patients opting for injectable therapies or surgery. This
represents significant commercial potential for Auxilium
We currently have a Neutral recommendation on Auxilium Pharma.
The stock carries a Zacks #2 Rank (short-term Buy rating). Auxilium
Pharma is on a roll with positive phase III data on Peyronie's. The
stock was up more than 16% on the news.
We are also positive on the company's efforts to drive Testim
sales. Auxilium Pharma recently signed an agreement with
) US subsidiary, GlaxoSmithKline LLC for the co-promotion of
Auxilium Pharma's Testim (1% testosterone), which is approved for
the treatment of hypogonadism or low testosterone level. We expect
Testim sales to benefit from the additional promotional effort.
AUXILIUM PHARMA (AUXL): Free Stock Analysis
GLAXOSMITHKLINE (GSK): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
To read this article on Zacks.com click here.