4SC AG has announced that the company has significantly enhanced the patent protection for its lead anti-cancer compound resminostat.
4SC has received a notification of allowance for patent protection of resminostat in China, the third largest pharmaceutical market worldwide, from the Chinese patent authority (SIPO).
Thus the granting of the composition-of-matter patent is now imminent. The patent, having a very broad extent of protection, covers the composition of matter of resminostat, pharmaceutical compositions comprising resminostat, and its therapeutic use in cancer and other areas.
China is by far the country with the highest incidence rates of liver cancer in the world and, therefore, of key importance for the further development and commercialization of resminostat.
Liver cancer (hepatocellular carcinoma, HCC), a disease with a high medical need and only very few treatment options available, is one of the indications currently addressed with resminostat in clinical Phase II trials.
Resminostat has recently shown excellent Phase II results in this indication, achieving a median overall survival (OS) of 8.0 months in second-line HCC patients in the combination treatment with sorafenib (Nexavar®).
According to the World Health Organization (GLOBOCAN 2008), there were more than 400,000 incidences of liver cancer in China in 2008 - accounting for 14% of all new cases of cancer in this country.
The number of new cases of liver cancer per year in China is expected to grow to 550,000 by the year 2020. According to IMS Health, China - with a total volume of 50 bn. USD - is the world's third largest pharmaceutical market behind the USA and Japan.
Until 2020, analysts estimate a further growth of this sector in China by 18 to 25% per year. Due to the high occurrence of hepatitis infections, liver cancer has particularly high incidence rates in the whole Asian-Pacific region.
4SC entered into a first development and commercialization partnership in this growth region in April 2011, when it granted an exclusive license for resminostat to Yakult Honsha, the Japanese market leader for gastrointestinal cancer therapies.
Dr. Ulrich Dauer, Chief Executive Officer of 4SC AG, commented: 'We are very pleased to obtain this key patent for our lead anti-cancer compound resminostat in China. This bolsters our competitive position in this large and attractive market as well as in the whole Asian-Pacific region, which is commercially very important for the development of resminostat in the indication of liver cancer (HCC). After we have recently shown excellent overall survival data in a Phase II trial in patients with advanced HCC, we are currently in talks with regulatory agencies and potential partners to prepare a global registration trial with resminostat in this indication. We believe that the enhanced patent protection in China will serve to further advance the successful progress of these talks with potential partners.'