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40 Valley Stream Parkway
Malvern, PA 19355 USA
phone:484-321-5900
fax:484-321-5999
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| Symbol |
AUXL |
| Exchange |
NASDAQ |
| Founded |
1999 |
| Employees |
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| www.auxilium.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Pharmaceuticals and drug-delivery systems for urology, sexual health, and Dupuytrens contracture |
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| Management |
| Armando Anido, Chief Executive Officer and President; Dr. Anthony DelConte, Chief Medical Officer; James E. Fickenscher, Chief Financial Officer; Roger D. Graham, Jr., Executive Vice President, Sales and Marketing; Jyrki Mattila, Executive Vice President, Business Development, Product Development and Technical Operations |
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| Keywords |
| intralesional, transmucosal, hormone, arthroscopy, corticosteroids |
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| Description |
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It is a specialty biopharmaceutical company focused on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Most of its products are designed for applications in urology and sexual health. |
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| Products / Services |
Auxilium currently markets its FDA approved Testim (R), a topical testosterone gel for the treatment of hypogonadism (low testosterone levels), and has four products in clinical development. Xiaflex(TM) is in phase III development for the treatment of Dupuytren's contracture and phase II development for the treatment of Peyronie's disease (disorders of connective tissue affecting the hands and penis, respectively) as well as frozen shoulder syndrome (adhesive capsulitis). Auxilium is in the early stages of cultivating its product pipeline of transmucosal film products, which includes candidates for the treatment of overactive bladder, pain, and various hormonal and urological conditions.
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| Technology / Differentiation |
| Testim is a clear, colorless gel that delivers testosterone subcutaneously into the body and through the bloodstream. Xiaflex (TM) is a clostridial collagenase-based therapy injected intralesionally. Most recently, Auxilium has developed an oral transmucosal drug-delivery system based on technology licensed from Formulation Technologies, Inc. (d/b/a PharmaForm). Transmucosal film enables the delivery of pharmaceuticals directly through the mucosal membrane, which can increase the rate of drug absorption and reduce first pass metabolism (a process that often lowers bioavailability of the drug shortly after the first dose). It is a cost-effective therapy that can potentially augment the therapeutic potency of the drug at lower concentrations or less frequent doses and allow for shorter onset of action. |
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| Market / Customers |
An estimated 481,000 new cases of hypogonadism are diagnosed in American men between the ages of forty and sixty-nine, adding to the 2.4 million American men of all demographics that currently suffer from the condition. According to National Prescription Audit Data from IMS Health, Inc., 120,500 (a 21.9% share of total prescriptions for testosterone gels) prescriptions for Testim (R) were dispensed in the first quarter of 2008. Another 1.4 million men currently live with Peyronie's disease and approximately 5% of Americans present with Dupuytren's contracture. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion.
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| Status |
| Auxilium reported the positive results of its Xiaflex (TM) CORD I phase III studies in Dupuytren's contracture in June 2008 (77.8% of patients experienced reduced joint curvature as its placebo group experienced 14.3% improvement); it also announced positive results from phase II trials in Peyronie's patients in October 2006. Auxilium hopes to secure FDA approval for Xiaflex (TM) in 2009 and has already secured exclusive global commercial rights for all future indications. Additionally, Testim (R) was awarded a U.S. patient on January 22, 2008. |
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