Biotechnology company, Exelixis, Inc., and international specialty healthcare company, Swedish Orphan Biovitrum (Sobi) have entered into a three-year agreement to support the distribution and commercialisation 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 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, 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) programme 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 programme and, upon EMA approval, its commercial development in 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.

A named patient use (NPU) programme provides access to unapproved drugs for a single patient or group of patients in a particular country. Products offered through NPU programmes can be investigational (e.g. still in clinical studies) or approved in one country but not yet approved in the patient’s home country. Regulations governing NPU programmes vary by country but companies offering products through NPU can sometimes charge for the product being administered.

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, tumour angiogenesis, and maintenance of the tumour micro-environment. Exelixis received approval by the FDA to market  Cometriq in the United States for the treatment of progressive, metastatic MTC in November 2012.

Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on  Cometriq (cabozantinib).

Swedish Orphan Biovitrum (Sobi) is an international specialty healthcare company dedicated to rare diseases and its mission is to develop and deliver innovative therapies and services to improve the lives of patients.