Pharmamar Announces That It Has Received Payment of $100M From Jazz Pharmaceuticals for the Approval of Zepzelcatm (Lurbinectedin) in the U.s.
PharmaMar (MSE:PHM) has today announced that it has received payment of $100 million from Jazz Pharmaceuticals (NASDAQ: JAZZ), corresponding to the first part of the regulatory milestones, for the approval of lurbinectedin in the U.S. for the treatment of pati
Benzinga · -
PharmaMar (MSE:PHM) has today announced that it has received payment of $100 million from Jazz Pharmaceuticals (NASDAQ: JAZZ), corresponding to the first part of the regulatory milestones, for the approval of lurbinectedin in the U.S. for the treatment of patients with metastatic SCLC. PharmaMar could receive up to an additional US $150 million once full approval is achieved. As reported on December 19 th , 2019, with the signing of the agreement between the two companies, PharmaMar will receive royalties, based on lurbinectedin's net sales, ranging from a percentage in the high teens, up to a maximum of 30 percent. In addition, PharmaMar may receive up to an additional US $550 million for commercial objectives. On June 15 th , 2020, PharmaMar and Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved Zepzelca TM (lurbinectedin) for the treatment of adult patients with metastatic SCLC with disease progression, after platinum-based chemotherapy. Lurbinectedin was approved under "A ccelerated Approval " based on Overall Response Rate (ORR) and Duration of Response (DoR). The FDA approval of this drug is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with relapsed SCLC 1 . The data, which appeared in the May 2020 issue of The Lancet Oncology , showed that in relapsed SCLC, lurbinectedin demonstrated an ORR of 35 percent and a median DoR of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC). This approval will allow Jazz to make lurbinectedin (Zepzelca TM ) commercially available in the U.S. in July.