Spanish company will receive €30M up front

Chugai Pharmaceutical is paying PharmaMar €30 million ($31.4 million) upfront for Japanese rights to the latter’s Phase III-stage, marine-derived anticancer drug PM1183 (lurbinectedin). The RNA polymerase II inhibitor is in development for the treatment of multiple tumor types. Phase III studies in platinum-resistant ovarian cancer and in small-cell lung cancer (SCLC) are in progress. At the end of November 2016, a Phase I trial was initiated in Japan to evaluate PM1183 in patients with certain types of unresectable/advanced solid tumors.

Under terms of the agreement PharmaMar will continue clinical development for the platinum-resistant ovarian cancer and SCLC indications in Japan, with Chugai carrying out registrational filing. PharmaMar could receive development and future sales milestones of over €100 million, plus tiered double-digit sales royalties. Chugai also has the rights to carry out clinical development of PM1183 for additional indications and may contribute to global development of the drug. PharmaMar retains exclusive production rights to lurbinectedin.

“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 COO, Tatsuro Kosaka. “We hope to obtain approval based on the clinical results attained so far, and also from new results that will come in the future”.

The deal for PM1183 is the second between Spanish firm PharmaMar and Chugai. In July 2014, the firms inked an agreement for the promotion of PharmaMar’s hematologic cancer drug candidate Aplidin® (plitidepsin), for the treatment of multiple myeloma, in eight European countries. During October, PharmaMar reported that the European Medicines Agency (EMA) had accepted for review the Marketing Authorization Application (MAA) for Aplidin in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). The drug is also undergoing a Phase Ib study in relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone.

PharmaMar’s marine-derived oncology therapeutics pipeline is headed by Yondelis® (trabectedin), a synthetically manufactured antitumor drug originally derived from the sea squirt. Yondelis is approved in more than 80 countries as monotherapy for the treatment of advanced soft tissue sarcomas and in Europe as combination therapy with doxorubicin for the treatment of relapsed ovarian cancer. Also in clinical development is PM184, a marine sponge-derived microtubule inhibitor that is in Phase I and Phase II development for treating various solid tumors, including hormone receptor-positive, HER2-negative locally advanced/or metastatic breast cancer.

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