Auxilium receives US$10m milestone payment from Asah Kasei Pharma
After successful application to PMDA for Xiaflex
Auxilium Pharmaceuticals, a speciality biopharmaceutical company based in Malvern, PA in the US, is to receive a US$10m regulatory milestone payment from its partner Asahi Kasei Pharma of Japan after a 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 the 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 30º at the start of therapy.
In March 2011 Auxilium entered into a development, commercialisation and supply agreement with Asahi Kasei.
'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 and President of Auxilium Pharmaceuticals.
Under the agreement, Asahi Kasei was granted the exclusive right to commercialise 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 commercialisation activities for the drug in Japan.
Auxilium is eligible to receive up to $247m in potential payments, with $37m tied to development and regulatory milestones and $210m tied to achievement of aggregate annual net sales thresholds.
As a consequence of the $10m milestone payment, the remaining potential payments and payments tied to regulatory milestones are reduced from $247m to $237m and from $37m to $27m, respectively.
In addition, Asahi Kasei would provide quarterly royalty payments based on tiered, double-digit percentages of the aggregate annual net sales of Xiaflex in Japan.
