4SC Expands Patent Protection for Epigenetic Anti-Cancer Compound

The oral agent 4SC-202 – a selective inhibitor of HDAC1, 2, and 3 – inhibits the cellular signal transduction pathways Hedgehog and Wnt which play a key role in cancer development and progression. The compound is currently being clinically investigated in a Phase I trial involving patients with haematological tumours. The results from this trial are expected to be available in the second half of 2013.

While the composition-of-matter patent for 4SC-202 was granted in China, granting is imminent in Hong Kong, according to the patent authorities. The patents cover the composition of matter of the 4SC-202 compound itself, pharmaceutical compositions comprising the compound, and its therapeutic use in cancer and in other therapeutic areas. After having obtained the composition-of-matter patent for 4SC-202 in the United States, the world’s largest pharmaceutical market, 4SC has now received a “notification of allowance” for the patent from the US Patent and Trademark Office covering certain salts of 4SC-202, among them tosylate salt. This will enable 4SC to significantly extend the duration of patent protection for 4SC-202 in the United States.

With sales of prescription drugs exceeding USD 279 billion, the USA are by far the world’s largest pharmaceutical market. According the the IMS Health information service, China is already the world’s third-largest market for pharmaceuticals behind the USA and Japan with an overall volume of around USD 50 billion. Analysts forecast strong annual growth of between 18% and 25% for the sector in China by 2020. Furthermore, the oncology market in Asia will see particularly strong growth and therefore become increasingly important for the development and marketing of innovative cancer drugs such as 4SC-202.Today, nearly half of all new cancer cases worldwide already occur in Asia.

“Strengthening patent protection for our innovative anti-cancer compound 4SC-202 in the key markets of the United States and China underscores the development strategy for 4SC-202,” commented Enno Spillner, CEO of 4SC AG. “In achieving this enhanced protection, we further strengthen our position as a leading biotech company in epigenetic cancer drugs.”

Enno Spillner continued: “Alongside our epigenetic value driver resminostat, 4SC-202 is the second promising epigenetic anti-cancer compound we have in clinical development. While our primary focus with resminostat is achieving market approval for the compound in combination therapy with conventional anti-cancer drugs for solid tumours such as liver cancer, we believe 4SC-202’s mechanism of action gives it major potential as a standalone treatment for haematological tumours, whose development and progression depends heavily on the Hedgehog and Wnt signalling pathways, which are of great therapeutic interest.”