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4SC and Yakult Honsha Announce Exclusive License Agreement for Japan for the Oral HDAC Inhibitor Resminostat

April 2011

 

Planegg-Martinsried, Germany and Tokyo, Japan, 14 April, 2011 – 4SC AG (Frankfurt, Prime Standard: VSC) and Yakult Honsha Co.; Ltd. (Tokyo: 2267) today announced the grant of an exclusive license by 4SC to Yakult Honsha for the development and commercialization of resminostat in Japan. Resminostat, an oral, pan-histone deacetylase (HDAC) inhibitor, is currently being evaluated in Phase II trials by 4SC in hepatocellular carcinoma (HCC), Hodgkin lymphoma (HL) and colorectal cancer in KRAS-mutant patients (CRC). Yakult Honsha will develop and commercialise resminostat primarily in HCC, CRC and retains the rights to develop and commercialise resminostat in other oncology indications in Japan.

Terms of the Agreement

4SC will receive an upfront payment from Yakult Honsha of €6 million and up to €127 million payable upon achieving specified milestones including clinical and regulatory events in Japan. In addition to milestone payments, Yakult will pay 4SC double-digit royalties linked to product sales of resminostat, which will also include the API costs. 4SC will be the exclusive supplier of resminostat to Yakult Honsha. Yakult Honsha will be responsible for all development and clinical requirements in Japan for resminostat in HCC, CRC and other chosen oncology indications.

Ulrich Dauer, CEO of 4SC, commented, “We are pleased to be entering this partnership with Yakult Honsha, which validates the potential of resminostat and delivers on our partnering strategy. As Yakult Honsha is the market leader in the gastrointestinal oncology field in Japan, we have found the most suitable partner for our core indications; hepatocellular carcinoma and colorectal cancer. We are looking forward to a mutually rewarding relationship and working together with this partner of choice.”

Shigeyoshi Sakamoto, Head, Pharmaceutical Division/Managing Director, Member of the Board, noted, “We are delighted to establish a partnership with 4SC, an expert in research and development of novel drugs for cancer. We believe that resminostat will contribute to the treatment of difficult cancers such as HCC, for which treatment needs remain to be met, and also to the treatment of CRC and other types of cancer. The open-label Phase II trials data have provided us with the confidence to more aggressively develop the drug.” More information about resminostat trials can be found on
www.clinicaltrials.gov.

-Ends

About Resminostat

Resminostat (4SC-201) is an oral pan-histone-deacetylase (HDAC) inhibitor. HDAC inhibitors modify the DNA structure of tumour cells to cause their differentiation and programmed cell death (apoptosis) and are therefore considered to offer a mechanism of action that has the particular potential to halt tumour progression and induce tumour regression. Resminostat is currently being investigated in the Phase II SHELTER study as a second-line treatment for advanced hepatocellular carcinoma, in the Phase I/II SHORE study as a second-line treatment in colorectal cancer in KRAS-mutant patients, as well as a third-line treatment in Hodgkin's lymphoma in the SAPHIRE trial.

In the HCC SHELTER study interim results from the first 13 patients assessed by tumor staging revealed that nine of them (69%) showed stable disease after six weeks of treatment. After 12 weeks of therapy six of 11 patients assessed to date (54%) displayed continued disease stabilization.

Interim results from the SAPHIRE trial in relapsed or refractory HL patients, based on the first Simon stage group of 18 patients, demonstrated that half of these patients experienced a clinical benefit from treatment with resminostat. Of those two patients could be assessed as partial responders (PR, i.e. with more than 50% reduction in size of tumour lesions). Seven patients displayed stabilization of their disease (SD) with diminished metabolic activities of their tumor lesions as examined by PET analysis (3/7 showed Partial Metabolic Response, PMR, with reduction of metabolic activity of their target lesions >25%, 4/7 showed Stable Metabolic Disease, SMD, with reduction of metabolic activity of their target lesions <25%).

SHORE trial will evaluate the efficacy, safety and pharmacokinetics of Resminostat as a second-line treatment in combination with FOLFIRI, a chemotherapy regimen for the treatment of colorectal cancer for patients with advanced and metastatic colorectal KRAS-mutant cancer. The first patient in the trial has been dosed in January, 2011.

About Yakult

Yakult Honsha is a leading Japanese company focused on the development and marketing of pharmaceuticals, foods, beverages, and cosmetics. As for pharmaceutical business Yakult Honsha has an emerging presence in oncology.

For more information on Yakult, visit: http://www.yakult.co.jp/english/index.html or view the following company profile

http://www.yakult.co.jp/english/pdf/profile2010-2011.pdf

About 4SC

4SC AG (ISIN DE0005753818) discovers and develops targeted small molecules for autoimmune and cancer indications. Vidofludimus (4SC-101), an IL-17 inhibitor, is currently in Phase II development in rheumatoid arthritis and inflammatory bowel disease (IBD), for which positive results from a Phase IIa study were recently reported. The company’s lead oncology compound, resminostat (4SC-201), an oral pan-histone deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular carcinoma, Hodgkin’s lymphoma and KRAS-mutant colorectal cancer. Two further oncology compounds, 4SC-203 and 4SC-205, are in Phase I studies. 4SC develops drug candidates until proof-of-concept in order to generate value creating partnerships with the pharmaceutical industry in return for advance and milestone payments as well as royalties.
Founded in 1997, 4SC has 94 employees and has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
For further information, please visit www.4sc.com.

Legal Note

This document may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially, depending on a number of factors.

 

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