Company Update (NASDAQ:EXEL): Exelixis, Inc. and Ipsen Amend Exclusive Licensing Agreement for the Commercialization and Development of Cabozantinib to Include Canada


Exelixis, Inc. (NASDAQ:EXEL) and Ipsen announced 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).

Signed in February 2016, the original agreement gave Ipsenexclusive 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.

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.

“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 Ipsenis 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. (Original Source)

Shares of Exelixis closed yesterday at $16.56, up $0.27 or +1.66%. EXEL has a 1-year high of $18.29 and a 1-year low of $3.55. The stock’s 50-day moving average is $15.78 and its 200-day moving average is $11.77.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on November 8, Leerink Swann analyst Michael Schmidt reiterated a Buy rating on EXEL, with a price target of $16, which represents a slight downside potential from current levels. Separately, on November 4, Cowen’s Eric Schmidt reiterated a Buy rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and Eric Schmidt have a yearly average return of 21.3% and 18.3% respectively. Schmidt has a success rate of 59% and is ranked #63 out of 4291 analysts, while Schmidt has a success rate of 52% and is ranked #100.

Overall, 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $16.50 which is -0.4% under where the stock closed yesterday.

Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its brands include COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib.