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GEN News Highlights : Nov 7, 2012

Pfizer, Auxilium End Xiapex Collaboration

Pfizer and Auxilium said today they made a “mutual decision” to end on April 24, 2013 their collaboration agreement to commercialize the adult Dupuytren's contracture drug Xiapex® in the 27 European Union and 19 other European and Eurasian countries.

As a result, Auxilium gains back rights to commercialize Xiapex as well as regulatory responsibility for the drug in these countries. Auxilium also gains $94 million in deferred revenue and $9 million of deferred costs toward its fourth-quarter results.

“We now have the strategic flexibility to evaluate all of our options for the continuing commercialization of Xiapex for the treatment of Dupuytren's contracture, and for gaining approval for Xiapex for the treatment of Peyronie's disease in the EU and other specified markets," Adrian Adams, Auxilium’s CEO and president, said in a statement.

“Auxilium remains committed to addressing the unmet needs of adult Dupuytren's contracture patients in the EU,” Adams added.

Xiapex is Auxilium’s European name for Xiaflex™ (collagenase clostridium histolyticum). Last year, Auxilium won a $30 million milestone payment from Pfizer following its first sale in a major EU market, the United Kingdom. With that payment, Auxilium racked up $45 million of regulatory milestones related to Dupuytren's contracture, and was eligible to receive up to $30 million in additional regulatory milestone payments for that indication.

Back in 2008, Pfizer and Auxilium launched a strategic alliance intended to commercialize the drug as the first, effective nonsurgical treatment for two diseases, adult Dupuytren's contracture and Peyronie’s.

At the time, Pfizer paid Auxilium $75 million upfront, and promised up to $410 million in additional payments, with $150 million tied to undisclosed regulatory milestones and $260 million based on undisclosed sales milestones. In addition, Auxilium was to receive increasing tiered royalties based on sales in Pfizer's territories.

In return, Pfizer agreed to share clinical development costs for certain trials required for the EU, and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex. Pfizer won a right of negotiation to obtain exclusive rights for commercializing Xiaflex pipeline indications in its territories.