Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced that the company will receive a $10 million regulatory milestone payment from its partner Asahi Kasei Pharma Corporation (Asahi Kasei). The payment is due because of the successful submission of a regulatory application to the Japanese Pharmaceutical and Medical Device Agency (PMDA) for Xiaflex (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture (DC)
The review by PMDA is expected to be completed by mid-2015. Xiaflex is a biologic approved in the US, EU, Canada and Australia for the treatment of adult DC patients with a palpable cord and, in the US for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
"We are pleased to see our collaboration with Asahi Kasei advance Xiaflex, if approved, as the potential first, effective non-surgical treatment option available in Japan for patients suffering from the debilitating effects of Dupuytren's contracture," said Adrian Adams, chief executive officer and president of Auxilium Pharmaceuticals. "This marks another important milestone in the continued expansion of Xiaflex to a global patient population."
In March 2011, Auxilium entered into a development, commercialization and supply agreement with Asahi Kasei.
Under the agreement, Asahi Kasei was granted the exclusive right to commercialize Xiaflex for the treatment of DC and PD in Japan upon receipt of applicable regulatory approvals. Asahi Kasei is primarily responsible for the clinical development, regulatory and commercialization activities for Xiaflex in Japan. Auxilium is eligible to receive up to $247 million in potential payments, with $37 million tied to development and regulatory milestones and $210 million tied to achievement of aggregate annual net sales thresholds. As a consequence of the $10 million milestone payment being made on account of the successful PMDA submission, the remaining potential payments and payments tied to regulatory milestones are reduced from $247 million to $237 million and from $37 million to $27 million, respectively. In addition, Asahi Kasei will provide quarterly royalty payments based on tiered, double-digit percentages of the aggregate annual net sales of Xiaflex in Japan.
DC is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with DC there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger's range of motion (how much a person can move or straighten them). Once the Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord."
Xiaflex (collagenase clostridium histolyticum, or CCH) is a biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and in the U.S. for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. Xiaflex consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. Xiaflex has been granted Orphan status in the U.S. by the FDA for DC and PD.
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.