Madrid/Tokyo, December 22, 2016 -- PharmaMar (MSE: PHM) has announced today the signing of an exclusive license, development and commercialization agreement with Chugai Pharmaceutical Co. Ltd. (Tokyo: 4519) for its third marine-derived anticancer drug PM1183 (lurbinectedin) in Japan. 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.
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 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.
About Chugai Pharmaceutical Co. Ltd.
Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area. In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated revenue in 2015 of Chugai totaled 498.8 billion yen and the operating income was 90.7 billion yen (IFRS Core basis). Additional information is available on the internet at http://www.chugai-pharm.co.jp/english.
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at www.pharmamar.com.
This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.
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