The European Medicines Evaluation Agency (EMEA) has given orphan drug status to ARQ 197, a treatment for Soft Tissue Sarcoma.
Medicinal products are designated as orphan drugs by EMEA when they are used to treat illnesses affecting small numbers of patients. This provides incentives for R&D investment such as exclusive distribution rights in the European Union for ten years, such that no other product with the same active ingredient can be used for the same therapeutic application.
ArQule is conducting phase 2 clinical trials with ARQ 197 in Microphthalmia Transcription Factor (MiT)-associated tumors. MiT is a subgroup of Soft Tissue Sarcoma. The orphan drug status and the early-2010 results of this clinical data will decide the advancement of this program.
ARQ 197 is also currently being evaluated in phase 2 clinical trials for non-small cell lung cancer, pancreatic cancer and hepatocellular carcinoma. It is a selective inhibitor of c-MET, a receptor tyrosine kinase.
ArQule and Daiichi Sankyo had signed a license, co-development and co-commercialization agreement for ARQ 197 in December 2008. The agreement applies to the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin has exclusive rights for development and commercialization.