PLANEGG-MARTINSRIED, Germany--(BUSINESS WIRE)--4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced that the European Medicines Agency (EMA) has recommended resminostat for designation as orphan medicinal product for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. The EMA's positive opinion has been forwarded to the EU commission for final approval and publication in the community register. This follows the recent orphan drug designation granted by the U.S. Food and Drug Administration for the same programme.
'Recommendation for orphan medicinal product designation in the EU is another important step in the development of resminostat, our most advanced oncology compound, as a potential targeted treatment for HCC,' commented Ulrich Dauer, Chief Executive Officer of 4SC AG. 'Both orphan drug designations from the EMA as well as from the FDA emphasise the importance of developing novel therapies in this indication in order to provide effective treatment options to patients suffering from this life-threatening disease. We are looking forward to working with both authorities closely as this programme progresses.'
The EMA's orphan medicinal product designation includes a ten-year period of market exclusivity from the date of approval for drugs and biologics that address rare diseases that affect no more than five in 10,000 people in the European Union. The designation also allows direct access to centralized marketing authorization, fee reductions and protocol assistance.
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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 and a Phase II study, the SAPHIRE trial, in third-line treatment in Hodgkin's lymphoma. These two trials are expected to report Phase II results in 2011. In addition, the Phase I/II SHORE study is evaluating resminostat as a second-line therapy setting in colorectal cancer in KRAS-mutant patients.
Resminostat is currently partnered in Japan with Yakult Honsha.
About 4SC
4SC (ISIN DE0005753818) discovers and develops targeted small-molecule drugs for the treatment of diseases with a high unmet medical need in various autoimmune and cancer indications. These drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. The company's balanced pipeline comprises promising products that are in various stages of clinical development. 4SC's aim is to generate future growth and enhance its enterprise value by entering into partnerships with leading pharmaceutical companies.
Founded in 1997, 4SC currently 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.
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| Language: | English | |
| Company: | 4SC AG | |
| Am Klopferspitz 19a | ||
| 82152 Martinsried | ||
| Germany | ||
| Phone: | +49 (0)89 7007 63-0 | |
| Fax: | +49 (0)89 7007 63-29 | |
| E-mail: | ||
| Internet: | ||
| ISIN: | DE0005753818 | |
| WKN: | 575381 | |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart |