Date: 2013-07-16
Type of information: Development agreement
Compound: Xiapex®(EU)/ Xiaflex® (USA) (collagenase clostridium histolyticum)
Company: Auxilium Pharmaceuticals (USA) Swedish Orphan Biovitrum (SOBI) (Sweden)
Therapeutic area:
Type agreement: development
supply
commercialisation
Action mechanism: In patients with Dupuytren’s contracture, the cords in the palm that prevent finger from straightening are made of fibres of a collagen. Xiapex® contains a mixture of two collagenases, enzymes that break up collagen. When injected into a cord, the collagenases break up the collagen fibres. This weakens and disrupts the cord, sometimes with the help of finger extension. The collagenases in Xiapex® are extracted from the bacterium Clostridium histolyticum.
Disease: Dupuytren's contracture, Peyronie's disease
Details: * On July 16, 2013, Auxilium Pharmaceuticals and Swedish Orphan Biovitrum (Sobi) have announcedthat 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. Under 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.Under 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 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.
Financial terms:
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