Date: 2012-07-09
Type of information: Development agreement
Compound: Xiapex®(EU)/ Xiaflex® (USA) (collagenase clostridium histolyticum)
Company: Actelion (Switzerland) Auxilium Pharmaceuticals (USA)
Therapeutic area: Inflammatory diseases
Type agreement: development
supply
commercialisation
Action mechanism:
Disease: Dupuytren's contracture, Peyronie's disease
Details: * On February 23, 2012, Auxilium Pharmaceuticals and Actelion have entered into a long-term partnership for the development, supply and commercialization of Xiaflex® (collagenase clostridium histolyticum), a novel, first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's disease. Under the terms of the agreement, Actelion will receive exclusive rights to commercialize Xiaflex® for the treatment of Dupuytren\'s contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Actelion will be primarily responsible for the applicable regulatory and commercialization activities for Xiaflex® in these countries.
Xiaflex® has been approved by the FDA and the EMA as a treatment for Dupuytren's contracture, and is also in development in Japan. In addition, Xiaflex® has been accepted for review by Health Canada for the treatment of Dupuytren's contracture in Canada and regulatory action is expected in the second half of 2012. Actelion expects to file for approval of Xiaflex® for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico over the next 12 months. Xiaflex® is also being evaluated in a global phase III development program for Peyronie's disease with top-line data expected in late second quarter 2012.
Financial terms: Under the terms of the agreement, Actelion will pay Auxilium $10 million upfront and will also make up to $16 million in potential regulatory, pricing and reimbursement milestone payments and $42.5 million in potential sales milestone payments. Auxilium will also receive increasing tiered double-digit royalties based on sales of Xiaflex® in Actelion' territories and will supply product to Actelion at a predetermined cost. So, Auxilium could receive up to $68.5 million in aggregate upfront, regulatory, pricing, reimbursement and sales milestones.
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. Actelion will be responsible for clinical development activities and associated costs corresponding to any additional trials required for specific territories.
Latest news: * On July 9, 2012 , Auxilium Pharmaceuticals and Actelion Pharmaceuticals Canada have announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for Xiaflex® (collagenase clostridium histolyticum or CCH) for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.
Pursuant to the collaboration agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for Xiaflex® in Canada and, upon approval, in the remainder of these countries. Actelion expects to make Xiaflex® available to patients in Canada in the first half of 2013.
Actelion expects to file for approval of Xiaflex® for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico by the end of the 2012. Auxilium recently announced positive top-line data from two pivotal, phase III trials of Xiaflex® for the potential treatment of Peyronie's disease and expects to file a sBLA for this second indication with the FDA by year-end 2012.
