Date: 2015-01-07
Type of information: Distribution agreement
Compound: Cometriq™(cabozantinib)
Company: Exelixis (USA) Sobi - Swedish Orphan Biovirum (Sweden)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: commercialisation
distribution
Action mechanism: tyrosine kinase inhibitor. Cometriq™ (cabozantinib) inhibits the activity of tyrosine kinases including RET, MET and VEGFR2. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.
Disease: metastatic medullary thyroid cancer
Details: Exelixis and Swedish Orphan Biovitrum (Sobi) have entered into a three-year agreement to support the distribution and commercialization of Cometriq™ (cabozantinib) for metastatic medullary thyroid cancer (MTC) in the European Union (EU) and potentially other countries. No other indication is covered by this agreement, and Exelixis maintains full commercial rights for Cometriq™ in MTC outside the covered territory and for all other indications on a global basis. On November 29, 2012, Exelixis announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for Cometriq™ for the proposed indication of treatment of progressive, unresectable, locally advanced, or metastatic MTC. Under the terms of the agreement, Exelixis will continue to be responsible for regulatory approvals in the covered territory. Sobi will serve as the exclusive distributor of Cometriq™ in the covered territory where applicable for NPU requests, and will, if approved by the EMA, promote, market, and sell Cometriq™ for MTC in the covered territory. Exelixis’ payments to Sobi include certain pre-determined fixed fees as well as potential performance based milestones related to the commercialization of the product in the covered territory. Exelixis will book revenues based on product sold to Sobi. Exelixis has the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees.
Financial terms:
Latest news: * On January 7, 2015, Exelixis announced that it has extended and restructured its agreement with Swedish Orphan Biovitrum AB (Sobi) to support the distribution and commercialization of Cometriq® (cabozantinib) for progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC) in the European Union (EU), Switzerland, Norway, Russia, and Turkey. The agreement, which was established in February 2013 and due to expire on December 31, 2015, will now extend to December 31, 2019. Moreover, the payment structure of the partnership will transition from fixed fees paid by Exelixis to Sobi to support initial build out of COMETRIQ European commercial infrastructure to a sales margin-based approach. Exelixis continues to maintain commercial rights for all other potential cabozantinib oncology indications on a global basis. Sobi exclusively markets, sells, and distributes Cometriq® for its MTC indication in the covered territory of the European Union, Switzerland, Norway, Russia, and Turkey. In parts of the territory where Cometriq® is not approved, Sobi administers a Named Patient Use program. Exelixis is responsible for regulatory approvals in the covered territory, and the company retains the ability to terminate the agreement at will at any time upon payment of certain pre-determined fees.
