Auxilium Pharma, Sobi Collaborate On XIAPEX In 71 Eurasian And African Countries

(RTTNews) - Auxilium Pharmaceuticals Inc. (AUXL) and Swedish Orphan Biovitrum AB (publ) or Sobi announced that they have entered into a long-term collaboration for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum), a novel, first-in-class biologic for the treatment of Dupuytren's contracture.

In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.

As per the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for these two indications, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries.

Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway. Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.

XIAFLEX/XIAPEX has been approved by the U.S. Food and Drug Administration, Health Canada and the European Medicines Agency as a treatment for Dupuytren's contracture for adult patients with a palpable cord, and is also in phase III development in Japan. In addition, a XIAFLEX submission has been filed for approval in Australia for the treatment of Dupuytren's contracture.

As per the terms of the collaboration agreement, Auxilium will receive significant tiered double-digit royalties based on sales of XIAPEX in Sobi's territories, which will also cover payment for product supply. Additionally, Sobi could make up to $40 million in potential sales milestone payments to Auxilium.

Auxilium said it will remain primarily responsible for the global development of XIAPEX in Dupuytren's contracture and Peyronie's disease and will be responsible for drug manufacturing and supply. Sobi will be responsible for clinical development and regulatory activities and associated costs corresponding to any additional trials required in its licensed territories.