March 23, 2011
Asahi Kasei Pharma Corp.

License agreement for XIAFLEX® collagenase clostridium histolyticum
Asahi Kasei Pharma has concluded a license agreement with Auxilium Pharmaceuticals, Inc. of the US on March 22, 2011, under which Asahi Kasei Pharma received exclusive rights to develop and market Auxilium's XIAFLEX* collagenase clostridium histolyticum in Japan.

XIAFLEX is a novel, first-in-class biologic, developed to address unmet medical needs through the provision of a nonsurgical treatment for Dupuytren's contracture and Peyronie's disease. By proceeding with the development of XIAFLEX under this agreement in order to obtain regulatory approval in Japan, Asahi Kasei Pharma is further reinforcing its R&D pipeline in its key strategic fields of orthopedics and urology.
Corporate profile of Auxilium Pharmaceuticals, Inc.
CEO: Armando Anido
Headquarter: Malvern, Pennsylvania, USA
Market capitalization:
(as of March 15, 2011)
US$1.1 billion (≈ ¥88 billion)
Business line: Development and marketing of products to predominantly specialist audiences, such as urologists, endocrinologists, hand surgeons, plastic surgeons who focus on the hand, and rheumatologists, as a specialty biopharmaceutical company
Sales (2010): US$211 million (≈ ¥16.9 billion)
  XIAFLEX (collagenase clostridium histolyticum), a biologic developed by Auxilium Pharmaceuticals, Inc., consists of a highly purified combination of several subtypes of collagenase derived from Clostridium histolyticum in specific proportion. As a locally injectable treatment, it is the first effective non-surgical therapy for adult Dupuytren's contracture patients with a palpable cord, and has been approved in the US and the EU for this indication. XIAFLEX is now also in Phase III of a global development program for the treatment of Peyronie's disease, and in Phase II of development for the treatment of frozen shoulder syndrome (adhesive capsulitis).
About Dupuytren's contracture
  Dupuytren's contracture is a condition that affects aponeurotic tissue (a kind of connective tissue) beneath the skin of the palm, causing a fixed flexion contracture of the fingers as the disease progresses. The incidence of Dupuytren's contracture is highest in Caucasians of Northern European descent, but there remain many unknowns regarding its pathogenic mechanism. XIAFLEX is the only drug which shows effectiveness for the treatment of Dupuytren's contracture, which has conventionally been treated by surgery.
About Peyronie's disease
  Peyronie's disease is the development of collagen plaque, or scar tissue, on the shaft of the penis that hardens and reduces flexibility, thus causing pain and forcing the penis to bend or arc during erection, possibly preventing intercourse. The disease occurs mostly in middle-aged men, and is possibly associated with other afflictions such as diabetes, erectile dysfunction (ED), and Dupuytren's contracture. The precise number of patients is unknown.
About Clostridium histolyticum
  Clostridium histolyticum is a bacterium that secretes various kinds of collagenase-like proteinase which decompose tissue for it to feed on and multiply. As it exhibits a strong enzymatic activity, the collagenase derived from Clostridium histolyticum is often used in the separation of cells from animal tissue during the course of various biochemical and physiological research.
About collagenase
  Collagenase is an enzyme which breaks apart collagen, a fibrous protein that plays a vital role in maintaining connective tissue and bones in animals.
* XIAFLEX is a registered trademark of Auxilium Pharmaceuticals, Inc.
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