PharmaMar and Chugai Pharmaceutical enter into a license and commercialization agreement for PM1183 in Japan.

PharmaMar has announced the signing of an exclusive license, development and commercialization agreement with Chugai Pharmaceutical Co. Ltd. for its third marine-derived anti-cancer drug PM1183 (lurbinectedin) in Japan.

Under the terms of the agreement, PharmaMar will receive an upfront payment of €30 million ($31.3 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 ($104.4 million).

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.

PM1183 is PharmaMar´s third anti-cancer 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.”

PharmaMar performs research and development focusing on the sea to discover molecules with antitumor activity. Chugai Pharma USA and Chugai Pharma Europe, members of the Roche Group, are engaged in clinical development activities in the United States and Europe.

(Source: PR Newswire)