VSC 4 SC AG

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 US Food and Drug Administration (FDA) has granted orphan drug designation to 4SC's lead oncology compound resminostat in Hodgkin's lymphoma (HL). Resminostat was recently granted orphan drug designation by the FDA in another oncology indication, hepatocellular carcinoma (HCC).

The oral pan HDAC inhibitor resminostat is currently being developed in three different oncology indications: hepatocellular carcinoma (HCC), colorectal cancer (CRC) and Hodgkin's Lymphoma (HL). On 6 September, 2011 4SC published positive topline results from its Phase II SAPHIRE study evaluating resminostat as a third-line treatment in relapsed/refractory HL patients. The study met its primary endpoint, showing a 33.3% overall response rate and 54.5% of patients achieving a clinical benefit from the treatment with resminostat. The final data including secondary endpoints will be presented at a forthcoming international scientific conference.

Ulrich Dauer, CEO of 4SC commented 'We are very pleased about yet another orphan drug designation by the FDA for our lead oncology compound resminostat in Hodgkin's lymphoma shortly after the presentation of positive topline data from our SAPHIRE study. The combined final data set of the SAPHIRE study in HL and the SHELTER study in HCC, which is anticipated by the end of this year, should encourage us to discuss our plans for a pivotal development programme for resminostat with regulatory authorities and potential partners in the near future.'

About Orphan Drug Designation by the FDA

Orphan drug designation is granted by the FDA to promote the development of products that may offer therapeutic benefits for diseases affecting less than 200,000 people in the USA. Orphan drug designations are based on several criteria that include frequency and seriousness of the condition, the lack of therapies and scientific merit of the proposed medicinal product and provide opportunities for significant fee and tax reductions before and after marketing authorization and the opportunity to obtain seven years of market exclusivity following drug approval, thereby offering competitive protection from similar drugs of the same class.

About Hodgkin's Lymphoma

Hodgkin's Lymphoma (HL) is a cancer of the lymphatic system, which is part of the immune system, and leads to the abnormal growth of lymphatic cells that compromise the immune system's ability to fight infection. The disease can spread beyond the lymphatic systems to other organs. The main causes for the development of HL are still unknown. Recent research shows that this tumour has its origin from a degenerated lymphatic cell, the B lymphocyte.

HL is curable in the majority of cases. However, not all patients can be cured and available therapies for this disease can have significant long-term toxicity. The incidence of HL in 2008 was 11,777 new cases in Europe and 8,220 new cases in the US. The age distribution is bimodal; the first peak occurs between the ages of 15 and 30 years and the second in the seventh decade.

Therapy options for HL patients depend on the stage of the disease and number and regions of lymph nodes affected. The first treatment line for HL, after the initial diagnosis, consists of chemotherapy and/or radiation, achieving cure rates of up to 80%. Standard of care for patients with refractory or relapsing disease after initial therapy consists of a salvage therapy comprising a conventional chemotherapy regimen usually followed by stem cell mobilization and subsequent high-dose chemotherapy along with autologous stem cell transplantation. Patients relapsing after second line therapy have a 5-year overall survival rate of only 17% [1]. Since there is no standard of care in patients with relapsed/refractory HL, there is an especially high need to develop novel therapies for these patients.

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 in the Phase I/II SHORE study as a second-line treatment in colorectal cancer in KRAS-mutant patients. The SHELTER study is expected to report Phase II results in 2011. Initial results of the SHORE study are expected in 2012.

The reported Phase II SAPHIRE trial for resminostat as a third-line therapy in Hodgkin's lymphoma is still ongoing as two patients are continuing on study therapy in the optional follow-up phase beyond 12 weeks of treatment.

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.

References

[1] Long-term outcome of ASCT in relapsed or refractory HL (Sirohi et al., Ann.Oncol., 2008)

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ISIN: DE0005753818 WKN: 575381 Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart