Auxilium, Biovitrum join hands for XIAPEX in Eurasia, Africa

Under the terms of the long-term research agreement, Sobi will receive exclusive rights to commercialize XIAPEX in 28 European countries, including Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries.

Through its Partner Products business unit, Sobi 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.

Auxilium will receive significant tiered double-digit royalties depending on the sales of XIAPEX in Sobi’s territories, which will also involve the product supply payment.

Additionally, Sobi could make up to $40m in potential sales milestone payments to Auxilium.

Auxilium will primarily be 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 the clinical development and regulatory activities, associated costs related to additional trials required in its licensed territories.

XIAFLEX/XIAPEX has been approved by the US Food and Drug Administration (FDA), 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.

A XIAFLEX submission has been filed for approval in Australia to treat Dupuytren’s contracture.