Auxilium Pharmaceuticals, Inc. and Asahi Kasei Pharma Corporation announced that they has entered into a long-term strategic alliance for the development, commercialization and supply of Xiaflex (collagenase clostridium histolyticum), a novel, first-in-class biologic for the treatment of Dupuytren's contracture and Peyronie's disease. Under the terms of the agreement, Asahi Kasei Pharma will receive exclusive rights to commercialize Xiaflex for the treatment of Dupuytren's contracture and Peyronie's disease in Japan. Asahi Kasei Pharma will be primarily responsible for the clinical development, regulatory and commercialization activities for Xiaflex in Japan.

Xiaflex has been approved by the US Food and Drug Administration and the European Commission for the treatment of Dupuytren's contracture. Asahi Kasei Pharma expects to begin clinical trials for Xiaflex for the treatment of Dupuytren's contracture in 2012. It is also being evaluated in a global phase III development programme for Peyronie's disease with top line data expected in the first half of 2012.

“Today, Asahi Kasei Pharma and Auxilium has forged a partnership, which we believe has the opportunity to offer the first, effective non-surgical treatment for two diseases in Japan,” said Armando Anido, CEO and president of Auxilium. “With the strength of Asahi Kasei Pharma's development and commercialization organizations in Japan, we believe this relationship greatly enhances our ability to effectively introduce this potentially ground breaking product.”

Asahi Kasei Pharma will pay Auxilium $15 million upfront. Under the terms of the agreement, Asahi Kasei Pharma will also make up to $247 million in potential milestone payments, with $37 million tied to development and regulatory milestones and $210 million based on sales milestones. Auxilium will receive increasing tiered double-digit royalties based on sales of Xiaflex in Japan and will supply product to Asahi Kasei Pharma at a predetermined cost.

“Our partnership with Auxilium reinforces Asahi Kasei Pharma's commitment to seek out innovative products that complement our existing portfolio in orthopaedics and urology and address significant unmet medical needs in Japan,” said Toshio Asano, president and representative director of Asahi Kasei Pharma. “We look forward to combining our organizational strengths to develop the potential for Xiaflex as a novel non surgical treatment for patients suffering from Dupuytren's contracture and Peyronie's disease in Japan.”

Auxilium will remain primarily responsible for the global development of Xiaflex in Peyronie's disease and will be responsible for all clinical and commercial drug manufacturing and supply. Asahi Kasei Pharma will be responsible for clinical development and regulatory activities and associated costs in Japan. Furthermore, Asahi Kasei Pharma will have a right of first negotiation to obtain exclusive rights to commercialize Xiaflex pipeline indications in Japan.

Xiaflex (collagenase clostridium histolyticum) is a biologic approved in the US and the EU for the treatment of adult Dupuytren's contracture patients with a palpable cord. Xiaflex is a novel non-surgical treatment for this condition and consists of a highly purified combination of several subtypes of collagenase, derived from clostridium histolyticum, in specific proportion. It is also in phase III of a global development program for the treatment of Peyronie's disease and is in phase II of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis). Together, they work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase.

Claims for Auxilium's US Patent No. 7,811,560 include, among other things, purified collagenase, which is the active component in Xiaflex (collagenase clostridium histolyticum). This patent entitled “compositions and methods for treating collagen-mediated diseases” is expected to expire in July 2028. The company has filed continuation applications with the USPTO, which, if granted, may expand the scope of patent claims covering Xiaflex. An international patent covering the same claims as the US patent is currently under review outside of the US.

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, 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. The incidence of Dupuytren's contracture is highest in Caucasians, historically those of Northern European descent, with a global prevalence of three to six percent of the Caucasian population. The incidence of Dupuytren's contracture in a Japanese population is estimated to be less than seen in Caucasian populations. Most cases of Dupuytren's contracture occur in patients older than 50 years.

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 US Food and Drug Administration for treatment of Dupuytren's contracture, which has historically been treated primarily by an open surgical procedure.

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. This may prevent intercourse. In addition to difficulty with sexual intercourse, Peyronie's disease may also be associated with emotional distress, bother, loss of self-esteem and depression.

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopaedic, general, and plastic surgeons who focus on the hand, and rheumatologists.

Asahi Kasei Pharma Corporation, is a research-based healthcare innovator that discovers, develops, manufactures, and markets products for the pharmaceutical, diagnostics, and medical nutrition markets.