4SC Signs Licensing and Development Agreement with Menarini

4SC AG and Singapore based Menarini Asia-Pacific Holdings Pte. Ltd. have announced that they have entered into a licensing and development partnership for 4SC's cancer compound resminostat for the Asia-Pacific region excluding Japan ("APAC").

Menarini AP, a member of the world's largest Italian biopharmaceutical group, the Menarini Group, will receive the exclusive licensing rights for the development and marketing of resminostat in all APAC countries, including among others China, South Korea, Australia, Thailand, Philippines, Indonesia, and Vietnam. Menarini AP will be responsible for the clinical development, regulatory approval and commercialization of resminostat in China, and other territories included in the agreement, in all oncological indications, and in particular liver cancer (HCC).

4SC will receive upfront and milestone payments totaling approximately up to EURO 95 million from Menarini payable upon achieving specified development, regulatory and commercialization milestones. In addition, 4SC will be eligible to double-digit royalties linked to product sales of resminostat.

The development of resminostat in APAC, and China in particular, is of key strategic importance to 4SC. Liver cancer (hepatocellular carcinoma, HCC), a large cancer indication with limited therapeutic options and one of the lead indications of resminostat's clinical development programme, has an extremely high incidence in this region. More than 75% of all HCC cases occur in the APAC region, largely in association with chronic hepatitis B virus (HBV) infection. Approximately 50% of HCC cases globally occur in China alone. HCC is currently the fifth most common cancer worldwide and the third most common cause for cancer-related mortality. The incidence of HCC cases globally is expected to grow strongly from about 700,000 per year in 2014 to over 1 million in 2030 (source: Globocan).

Enno Spillner, Chief Executive Officer of 4SC, said: "We are delighted to be entering into this partnership with Menarini. This is a further step in the clinical development of our lead compound resminostat for Asia, which is an important market with significant and growing medical need - in particular in the indication of liver cancer. Menarini, a multinational pharma player of European origin, has a strong footprint in the APAC region. We are convinced that Menarini AP, with its vast commercial experience in Asia and broad capabilities in clinical development and regulatory processes, is a perfect partner for us - and an ideal complement to our existing resminostat partner Yakult Honsha in Japan."

John Graham, Chief Executive of Menarini AP commented, "Oncology represents a strategic area of focus for the Menarini Group. We are delighted to be embarking on a partnership with 4SC in Asia on resminostat that offers promise as a therapeutic option in liver cancer, among others, one of the most prevalent forms of cancer in Asia and one with the highest unmet need."