European Medicines Agency Adopts Positive Opinion for Orphan Medicinal Product Designation for 4SC's Resminostat to Treat Hep...
July 26 2011 - 1:50AM
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.
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 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.
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.
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:
public@4sc.com
Internet:
www.4sc.de
ISIN: DE0005753818 WKN: 575381 Listed: Regulierter Markt in
Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf,
München, Stuttgart
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