Woburn, Massachusetts-based biotechnology company ArQule, Inc. (ARQL) said Wednesday that its ARQ 197 is granted an orphan drug designation for the treatment of soft tissue sarcoma by the European Medicines Evaluation Agency, or EMEA.
In addition to soft tissue sarcoma, ARQ 197 is currently being evaluated in mid-stage clinical trials for non-small cell lung cancer, pancreatic cancer and hepatocellular carcinoma. Additional trials with ARQ 197 are ongoing in MiT, or Microphthalmia Transcription Factor-associated tumors.
The orphan drug status to ARQ 197 entails market exclusivity throughout the European Union for 10 years, as well as, incentives for investment in the research and development.ArQule added that the evaluation of clinical data from the phase 2 trials of ARQ 197 as an orphan medical product in soft tissue sarcoma is expected in early 2010, and will also inform the decisions related to the advancement of the program.
Last year, ArQule and Daiichi Sankyo had entered a license, co-development and co-commercialization agreement for developing ARQ 197 in the U.S., Europe, South America and the rest of the world. However, in Japan, China, South Korea and Taiwan, Kyowa Hakko Kirin Co., Ltd. has the exclusive rights for development and commercialization.
ARQL is currently trading up 2.73% at $4.55, on the Nasdaq.
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