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Auxilium, Actelion enter into partnership to develop, commercialize Xiaflex in certain countries

Thursday, February 23 2012 | Comments
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Auxilium Pharmaceuticals Inc. and Actelion Pharmaceuticals Ltd. formed a long-term collaboration to develop, supply and commercialize Auxilium's Xiaflex (collagenase clostridium histolyticum), a first-in-class biologic for the potential treatment of Dupuytren's contracture and Peyronie's disease, in Canada, Australia, Brazil and Mexico.

Under the agreement, Actelion will pay Auxilium $10 million up front. Auxilium could also receive as much as $16 million in regulatory, pricing and reimbursement milestone payments and $42.5 million in sales milestone payments. In addition, Auxilium will receive increasing tiered double-digit royalties based on Xiaflex sales in Actelion's territories and will supply the product to Actelion at a predetermined cost.

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 when the drug is approved in those countries. Actelion will be primarily responsible for the applicable Xiaflex-related regulatory and commercialization activities in those countries.

The Food and Drug Administration and the European Medicines Agency have approved Xiaflex as a treatment for Dupuytren's contracture, and the drug is in development in Japan. Health Canada is reviewing the drug for approval in the Dupuytren's contracture indication in Canada.

Actelion anticipates filing for approval of Xiaflex as a treatment for Dupuytren's contracture in Australia, Brazil and Mexico within the next year.

The drug is also being evaluated in a global Phase III development program for Peyronie's disease. Top-line data are expected to be available by the end of the second quarter.

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