Exelixis, Inc. (NASDAQ:EXEL) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced that they 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.
“We are pleased to be working with Sobi to distribute and commercialize COMETRIQ for MTC in the EU, while at the same time maintaining commercial rights for all other oncology indications on a global basis,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “By contracting with Sobi for distribution and commercialization services, we believe we will be able to realize the full value of the MTC opportunity in Europe and potentially other regions without the need for a large-scale investment in sales and marketing infrastructure. This strategy is consistent with our commitment to match our commercialization investments with the potential value of each opportunity. We look forward to working with Sobi, which has proven sales and marketing expertise in Europe, to make COMETRIQ available under a Named Patient Use (NPU) program and then more broadly assuming EMA approval.”
“COMETRIQ is an important potential new treatment option for patients with metastatic MTC,” said Anders Edvell, Vice President and Head of Partner Products at Sobi. “We look forward to leveraging our years of specialized expertise in these markets to support the COMETRIQ NPU program and, upon EMA approval, its commercial development in MTC.”