Auxilium Announces Availability of
XIAFLEX™ for the Treatment of Dupuytren's Contracture
MALVERN, PA, Mar 08, 2010 (MARKETWIRE via COMTEX) -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, is now available by prescription in the United States for the treatment of adult Dupuytren's contracture patients with a palpable cord.
The Company has established a distribution network that will allow health care providers to access XIAFLEX in an office setting through specialty distributors and specialty pharmacies or, in the institutional setting, through selected wholesalers. Physicians can receive XIAFLEX after they have undergone training on XIAFLEX, and enrolled themselves and their site of care in the distribution network.
For more information about XIAFLEX, including patient assistance and co-pay programs, physicians and potential patients with Dupuytren's contracture can contact the XIAFLEX Xperience™ patient program at 1-877-XIAFLEX from 8:00 a.m. to 8:00 p.m. Eastern Time. For full U.S. Prescribing Information and Medication Guide, please visit: http://www.XIAFLEX.com.
"XIAFLEX is the first and only FDA-approved nonsurgical treatment for Dupuytren's contracture and we believe it could represent a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," said Armando Anido, Chief Executive Officer and President of Auxilium. "I am extremely proud of the XIAFLEX team, whose commitment and hard work have allowed us to give patients access to XIAFLEX just five weeks following FDA approval. We are committed to making XIAFLEX broadly available to appropriate Dupuytren's patients and have implemented patient and healthcare professional assistance programs to support the launch of XIAFLEX."
Important Safety Information
XIAFLEX's full prescribing information (PI) is available via our website at www.XIAFLEX.com
About Dupuytren's Contracture
Dupuytren's contracture is a condition that affects the connective tissue that lies beneath the skin in the palm. The disease is progressive in nature. Typically, skin pits then nodules develop in the palm as collagen deposits accumulate. As the disease progresses, the collagen deposits form a cord that stretches from the palm of the hand to the base of the finger. Once this cord develops, the patient's fingers contract and the function of the hand is impaired. Currently, surgery is the only effective treatment. The incidence of Dupuytren's disease, inclusive of pits, nodules and cords, is highest in Caucasians, historically those of Northern European descent, with a global prevalence of three to six percent of the Caucasian population. (1) Most cases of Dupuytren's contracture occur in patients older than 50 years. (2)
The most frequently affected parts of the hand associated with Dupuytren's contracture are the joints called the Metacarpal Phalangeal Joint, or MP joint, which is the joint closest to the palm of the hand and the Proximal Intra-Phalangeal Joint, or the PIP joint, which is the middle joint in the finger. The little finger and ring finger are most frequently involved. XIAFLEX is the only drug approved by the U.S. Food and Drug Administration for treatment of Dupuytren's contracture, which has historically been treated primarily by an open surgical procedure.
(1) Hurst, L. C. et al., Injectable Collagenase Clostridium Histolyticum
for Dupuytren's Contracture, New England Journal of Medicine,
(2) Badalamente, M. A., Hurst, L. C. et al., Collagen as a Clinical Target:
Nonoperative Treatment of Dupuytren's Disease, The Journal of Hand Surgery,
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets XIAFLEX™ (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism. Auxilium has four projects in clinical development. XIAFLEX is in phase IIb of development for the treatment of Peyronie's disease and is in phase II of development for treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) and its fentanyl pain product using its transmucosal delivery system are in phase I of development. The Company is currently seeking a partner to further develop these product candidates. Auxilium has rights to additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations. For additional information, visit http://www.auxilium.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding XIAFLEX as a major breakthrough for patients with Dupuytren's contracture; the distribution network for XIAFLEX; the number of patients with Dupuytren's contracture; products in development for Peyronie's disease, Frozen Shoulder syndrome, overactive bladder, pain, hormone replacement and urologic disease; and all other statements containing projections, statements of future performance or expectations, our beliefs or statements of plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Forward-looking statements can generally be identified by words such as "believe," "appears," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and other words and terms of similar meaning in connection with any discussion of projections, future performance or expectations, beliefs, plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including further evaluation of clinical data, results of clinical trials, decisions by regulatory authorities as to whether and when to approve drug applications, and general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in Auxilium's Annual Report on Form 10-K for the year ended December 31, 2009 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of Auxilium's home page on the Internet at http://www.Auxilium.com under the heading "For Investors -- SEC Filings." There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide Auxilium's expectations, plans or forecasts of future events and views as of the date of this release. Auxilium anticipates that subsequent events and developments will cause Auxilium's assessments to change. However, while Auxilium may elect to update these forward-looking statements at some point in the future, Auxilium specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Auxilium's assessments as of any date subsequent to the date of this release.
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
Auxilium Pharmaceuticals, Inc.