Application for approval to manufacture and sell XIAFLEX® (collagenase clostridium histolyticum) in Japan

July 31, 2014
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma today filed an application for approval to manufacture and sell XIAFLEX* collagenase clostridium histolyticum in Japan. XIAFLEX is a biologic developed by Auxilium Pharmaceuticals, Inc. of the US. Asahi Kasei Pharma concluded an agreement with Auxilium Pharmaceuticals in March 2011, under which Asahi Kasei Pharma received exclusive rights to develop and market XIAFLEX in Japan. Asahi Kasei Pharma hopes that XIAFLEX will provide a nonsurgical treatment option for Dupuytren’s contracture in Japan.


Product name:   XIAFLEX injection 0.58 mg (tentative)
Indication:   Dupuytren’s contracture with a palpable cord (tentative)
Characteristics:   XIAFLEX 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 is approved and sold in the US, the EU, Canada, and Australia for this indication.

Corporate profile of Auxilium Pharmaceuticals, Inc.

CEO:   Adrian Adams
Headquarters:   Chesterbrook, Pennsylvania, USA
About Auxilium:   Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences. With a broad range of first- and second-line products across multiple indications, Auxilium is an emerging leader in the men's healthcare area and has strategically expanded its product portfolio and pipeline in orthopedics, dermatology and other therapeutic areas. The Company now has a broad portfolio of 12 approved products. To learn more, please visit

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 Clostridium histolyticum

Clostridium histolyticum is a gram-positive bacterium that secretes various kinds of collagenase-like proteinase which decompose tissue for it to feed on and multiply. As they exhibit strong enzymatic activity, the collagenases derived from Clostridium histolyticum are often used in the separation of cells from animal tissue during the course of various biochemical and physiological research.

About collagenases

Collagenases are enzymes which break 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.


Adobe Readeris required to view these PDF files.

page top