March 1, 2016
By Mark Terry, BioSpace.com Breaking News Staff
South San Francisco-based Exelixis, Inc. and Paris-based Ipsen announced yesterday that they had inked an exclusive licensing agreement to commercialize and develop cabozantinib, Exelixis’ lead cancer drug.
Ipsen will gain exclusive rights to commercialize cabozantinib for current and future indications outside the U.S., Canada and Japan. This applies to rights to Cometriq, which is approved in Europe for the treatment of adults with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).
In addition, the two companies will collaborate on developing cabozantinib for other indications. Exelixis will hold exclusive commercial rights for the drug in the U.S. and Canada, and is continuing discussions to partner commercial rights in Japan.
Ipsen is paying Exelixis $200 million upfront, and Exelixis is eligible for various milestone payments, including $60 million for approval of the drug in Europe for advanced renal cell carcinoma (RCC) and $50 million when it files and gets approval for cabozantinib in Europe for advanced hematocellular carcinoma (HCC). Additional milestones are possible, as well as up to $545 million in commercial milestone payments and tiered royalties up to 26 percent of Ipsen’s net sales of the drug.
“The robust results from the METEOR study in advanced renal cell carcinoma demonstrate that cabozantinib has the potential to become a key oncology product in Europe,” said Marc de Garidel, chairman and chief executive officer of Ipsen, in a statement. “This transaction will help Ipsen accelerate the growth of the company and strengthen its oncology footprint in Europe. We are excited to bring cabozantinib to patients and clinicians around the world.”
Exelixis was recently chosen by The Motley Fool’s Brian Feroldi as a company to watch because it is likely to have a fast burn, comparing the company to Gilead Sciences when it was a rising star. He cited the recent positive results from the METEOR study, which showed a “highly statistically significant and clinically meaningful increase in overall survival (OS) for patients randomized to cabozantinib as compared to everolimus.” Which is to say, it demonstrated a 42 percent drop in the rate of disease progression or death compared to Afinitor.
Also, in November 2015, the company announced that the U.S. Food and Drug Administration (FDA) had approved Cotellic (cobimetinib) for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. Exelixis has a deal with Genentech and Roche for the drug, which analysts think is likely to be approved.
Exelixis is showing a slight bump recently, although the last six or seven months have been volatile. Shares traded on Aug. 4 for $6.62, dropped on Aug. 24 to $5.08, and rose to $6.53 on Sept. 18. Then shares dropped to $3.64 on Feb. 29, 2016. Shares are currently trading for $4.02.
The company also released its fourth quarter and full year financials yesterday. For 2015, the company reported total revenues of $37.2 million, up from the 2014 figure of $25.1 million. Operational losses were lower, at $121.4 million in 2015 compared to $224.5 million in 2014.
“Exelixis began 2016 with significant momentum as a result of the major milestones that occurred during and shortly after the fourth quarter,” said Michael Morrissey, president and chief executive officer of Exelixis, in a statement. “Most notably, we now have a more complete picture of cabozantinib’s clinical activity and potential in advanced renal cell carcinoma, a patient population greatly in need of new treatment options.”
