Exelixis, Sobi extend distribution agreement for COMETRIQ for medullary thyroid cancer

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.

"Our amended agreement with Sobi will continue to allow Exelixis to provide COMETRIQ to MTC patients outside the United States," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis.

"Over the course of this coming year, we anticipate reaching several key milestones for the company, including receipt of top-line data from the METEOR phase 3 trial of cabozantinib in metastatic renal cell carcinoma in the second quarter, and regulatory progress with our partnered compound cobimetinib for metastatic melanoma in both the United States and European Union."

"We are very pleased to extend the agreement with Exelixis and proud to support access to COMETRIQ in Europe. The evolution of our partnership with Exelixis will continue to bring significant value to patients," said Anders Edvell, Vice President and Head of Sobi Partner Products at Sobi.

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.

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGFRs and RET. 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.

COMETRIQ (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.

Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.