PharmaMar SA and Jazz Pharmaceuticals PLC entered into an exclusive license deal for lung cancer drug Zepsyre, or lurbinectedin, in the U.S.
Under the agreement's terms, PharmaMar will receive an up-front payment of $200 million and up to $250 million if certain regulatory milestones are achieved.
PharmaMar could also receive up to $550 million in potential commercial milestone payments, as well as royalties from a percentage in the high teens to as much as 30% of future net sales of the drug. The Madrid-based pharmaceutical company, which retains production rights for Zepsyre, may receive additional payments upon the drug's approval in other indications.
The closing of the deal is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act, a U.S. antitrust law.
PharmaMar also has submitted a new drug application to the U.S. Food and Drug Administration for the accelerated approval of Zepsyre for treating patients whose small cell lung cancer, or SCLC, has returned and progressed after prior platinum-based therapy.
The application is based on a phase 2 study in which Zepsyre helped shrink tumors in patients with SCLC, meeting the trial's main goal of overall response rate. The study consisted of 105 patients from nine countries in Europe and the U.S.
In 2018, the U.S. FDA granted Zepsyre orphan-drug designation for SCLC.
PharmaMar's shares were up almost 18% to €2.87 as of 4:35 p.m. Madrid time on Dec. 19.