On December 21, 2016 Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) jointly reported an amendment to the exclusive collaboration and licensing agreement for the commercialization and continued development of cabozantinib, to include commercialization rights in Canada for Ipsen where Ipsen has an established business (Mississauga, Ontario) (Press release, Exelixis, DEC 21, 2016, View Source [SID1234517144]). Signed in February 2016, the original agreement gave Ipsen exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. Following the amendment, Exelixis maintains exclusive rights for cabozantinib in the United States and Japan, and is continuing discussions with potential partners for commercial rights in Japan. Schedule your 30 min Free 1stOncology Demo! Under the terms of the amendment, Exelixis will receive a $10 million upfront payment. Exelixis is eligible to receive regulatory milestones, for the approvals of cabozantinib in Canada for advanced renal cell carcinoma (RCC) after prior treatment, for first-line RCC, and advanced hepatocellular carcinoma (HCC), as well as additional regulatory milestones for potential further indications. In line with the prior transaction between the parties, the agreement also includes commercial milestones and provides for Exelixis to receive tiered royalties on Ipsen’s net sales of cabozantinib in Canada.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Exelixis and Ipsen have made significant progress together since signing our collaboration and licensing agreement in February, and considering the substantial business resources that Ipsen has in Canada, amending the terms to grant Ipsen Canadian rights is a natural next step," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "Over the past nine months, CABOMETYX received regulatory approval for advanced RCC in the United States as well as the European Union, where Ipsen recently began launching the product. Our collaboration with Ipsen is strong, and we look forward to continued progress as they pursue approval and commercialization in Canada."
David Meek, Chief Executive Officer of Ipsen, said, "Gaining commercial rights for CABOMETYX in Canada expands our geographic footprint and strengthens our Oncology franchise in North America, one of our key geographic regions and main drivers of growth. This announcement follows numerous advancements in the CABOMETYX program, including the recent approval in Europe. We are now focused on a successful European launch and are pleased to offer advanced renal cell carcinoma patients a new treatment option supported by a strong clinical profile. We look forward to continue working with our partner Exelixis to advance the cabozantinib program."
CABOMETYX was approved in the European Union (EU) on September 9, 2016 for the treatment of RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Ipsen is currently initiating the launch of CABOMETYX in the EU. The regulatory filing in Canada is expected in 2017, with regulatory approval anticipated in early 2018.
About CABOMETYX
CABOMETYX is the tablet formulation of cabozantinib. Its targets include MET, AXL and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis and drug resistance.
CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.
On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On September 9, 2016, the European Commission approved CABOMETYX tablets for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland.
About Exelixis’ Exclusive Licensing Agreement with Ipsen
In February 2016, Exelixis granted Ipsen exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States, Canada and Japan. On 20 December 2016, Exelixis granted Ipsen the commercial and development rights for cabozantinib in Canada. As provided in their agreement, Exelixis and Ipsen are also collaborating on the development of cabozantinib for current and potential future indications.