TOKYO, Japan and FLORENCE, Italy I November 28, 2016 I Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Berlin-Chemie Menarini, a company of the Menarini Group, announced that both companies have entered into a global license agreement for PA799, class I PI3K inhibitor.

PA799 is the PI3K inhibitor originated by Chugai, which conducted phase I study for solid tumors in Europe. With its high selectivity for class I enzyme, the drug candidate showed a good safety profile in the clinical trial.

“We are pleased to sign a license agreement for PA799 with Menarini Group,” said Chugai’s Representative Director, President and Chief Operating Officer, Tatsuro Kosaka. “PI3K is assumed to be one of the important kinases in the signaling pathway for the proliferation, the differentiation and the survival of tumor cells. We hope that the development of PA799 by Menarini Group will bring benefit to the patients as early as possible.”

“We are excited about the opportunity to develop this anti-cancer agent, we believe in the mechanism of action of the PA799, and we are confident it will bring a great value to cancer patients in the world,” said Reinhard Uppenkamp, Chief Executive Officer of Berlin-Chemie Menarini. “The scientific skills of Chugai and ability to conduct clinical trials and regulatory activities of Menarini Group will be in synergy for the future development of this product.”

“We welcome the achievement of this strategic partnership with Chugai. This agreement allows us to add a key component in our portfolio, in fact, we make today a key step in the effort to expand the multimodal oncology pipeline of Menarini Group.” said Lucia Aleotti, Chairman of Menarini Group.

Under the agreement, Chugai will grant Menarini Group an exclusive license for the manufacturing, development and marketing of PA799 worldwide. Under the terms of the agreement, Chugai will receive an upfront, milestone and royalty payments from Menarini Group.

About Chugai

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

About Berlin-Chemie Menarini

Dynamic growth, drug innovations and a wealth of experience that has matured over generations are the hallmarks of Berlin-Chemie Menarini.

The company wholly belongs to Italy’s global Menarini Group and works mainly for the development of business in Germany, Central and Eastern Europe. As one of the Menarini Group’s six research sites, Berlin-Chemie is fully integrated in the research programme of the group, with a special focus on oncology. Berlin-Chemie Menarini is an innovation- and growth-orientated company with above average sales development (2015: 1,495 million €). About two thirds of the company’s prescription drugs sold domestically are innovative preparations. Berlin-Chemie maintains its own branches in more than 30 countries of Central and Eastern Europe. Large-scale investment is taking place to further strengthen market positions.

About The Menarini Group

The Menarini Group is 19th in Europe out of 5,541 companies, and 39th company in the world out of 21,317 companies, with a turnover of over 3.3 billion Euro and more than 16,000 employees. The Menarini Group has always pursued two strategic objectives: Research and Internationalisation. Menarini is present in the most important therapeutic areas including cardiovascular products, gastroenterology products, oncology, andrology, antibiotics/respiratory products, drugs used in diabetology, anti-inflammatory agents/analgesics. With a consolidated presence throughout Europe and in the major countries of Asia, Africa, Central and South America, its own 6 Research Centres and 15 Production sites, Menarini products are available to patients in more than 100 countries worldwide. Menarini is also active in the area of cancer precision medicine through Menarini Silicon Biosystems, that has developed the DepArray technology, and through Menarini Biomarkers, with laboratories based in Singapore. For more information about Menarini Group, please visit:

SOURCE: Chugai Pharmaceutical Co