On December 22, 2016 PharmaMar (MSE:PHM) reported the signing of an exclusive license, development and commercialization agreement with Chugai Pharmaceutical Co. Ltd. (TSE:4519) for its third marine-derived anticancer drug PM1183 (lurbinectedin) in Japan (Press release, PharmaCyte Biotech, DEC 22, 2016, View Source [SID1234517158]). Under the terms of this agreement, PharmaMar will receive an upfront payment of €30 million, along with double-digit tiered royalties, and will also be eligible for receiving payments in line with the progress of the development and sales milestones; potentially worth over €100 million. Schedule your 30 min Free 1stOncology Demo! PharmaMar will continue to conduct the clinical development activities for the first two indications of PM1183 (platinum-resistant ovarian cancer and small cell lung cancer) in Japan, whereas Chugai will make milestone payments at study initiation and will be responsible for registration filing. In addition, Chugai will have the rights to conduct clinical development in Japan to pursue additional indications and may contribute to the global development. PharmaMar will retain the exclusive production rights of lurbinectedin and will supply the API to Chugai.
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PM1183 is PharmaMar´s third anticancer drug and is currently under development for the treatment of several types of solid tumors. The Company has recently completed the recruitment of patients in a Phase III study in platinum resistant ovarian cancer, and during the month of August, a pivotal Phase III trial in small cell lung cancer was initiated.
According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we are about to address our second strategic alliance with Chugai for the commercialization of a marine based anti-tumor compound. With this agreement, we will contribute to the sale of PM1183 in Japan. Meanwhile, we shall continue with the clinical development of the molecule and to advance in the upcoming regulatory steps to obtain its approval in the years to come".
"Both companies share the same value to bring PM1183 – an innovative marine based medicine to the Japanese patients so that we can contribute to the treatment," said Chugai’s Representative Director, President and Chief Operating Officer, Tatsuro Kosaka. "Chugai is committed to continuously provide innovative medicines to the patients. We hope to obtain approval based on the clinical results attained so far, and also from new results that will come in the future".
About PM1183 (lurbinectedin)
PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.