ArQule, Inc., a clinical stage biotechnology company, engages in the research and development of therapeutics to treat cancers and rare diseases. The company intends to produce drugs that target biological pathways implicated in a range of cancers and certain non-oncology indications. Its clinical stage pipeline consists of four product candidates, all of which are in targeted, biomarker-defined populations. Product Candidates The company’s main product candidate is tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase and its biological pathway. The company and its partners, Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) and Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), are in the process of implementing a worldwide clinical development program with tivantinib. The company also has completed earlier-stage combination therapy trials and pre-clinical experiments with tivantinib and other anti-cancer agents that may provide data to support trials in additional indications. The company has collaborated with the National Cancer Institute (NCI) through its Cancer Therapy Evaluation Program (CTEP) to explore the clinical potential of tivantinib in various tumor indications while the company focuses its internal efforts on the two Phase 3 programs in hepatocellular carcinoma. These CTEP-sponsored trials include Phase 2 single agent trials in prostate cancer (randomized), multiple myeloma, breast cancer and malignant mesothelioma, and Phase 2 combination therapy trials in kidney cancer (with or without erlotinib, randomized) and head and neck cancer (with or without cetuximab, randomized). The company’s other product candidates include the following: ARQ 092, designed to inhibit the AKT serine/threonine kinase; ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor family; and ARQ 761, a Beta lapachone analog being evaluated in investigator-sponsored testing as a promoter of NQ01-mediated programmed cancer cell necrosis. Partnerships Daiichi Sankyo Co., Ltd.: In 2008, the company entered into a license, co-development and co-commercialization agreement with Daiichi Sankyo Co., Ltd. to conduct research, clinical trials and the commercialization of tivantinib in human cancer indications in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co., Ltd. has exclusive rights for development and commercialization. Kyowa Hakko Kirin Co., Ltd.: In 2007, the company announced an exclusive license agreement with Kyowa Hakko Kirin Co., Ltd. to develop and commercialize tivantinib in Japan and parts of Asia. Strategy The company’s strategy is to build a fully integrated, commercial-stage biotechnology company that discover, develop, manufacture, market, and sell small molecule drugs, in the fields of oncology and rare diseases. Specifically, the company intends to accomplish this through the following activities: implementation of a clinical development program across multiple tumor types with its lead product candidate, tivantinib, as monotherapy and in combination with other targeted therapies or cytotoxic agents; continued refinement and prioritization of its clinical program with tivantinib based on its expanding knowledge of c-Met receptor tyrosine kinase inhibition, the mechanism of action of tivantinib, and emerging data from clinical trials; focus on personalized medicine approaches to drug development and define patient populations with the highest likelihood of benefitting from its therapies based on its insights into functional biomarkers; expansion into rare disease indications that could provide the opportunity for accelerated development; ongoing portfolio prioritization based on the completion of ongoing Phase 1b trials for ARQ 092 and ARQ 087 to select the most promising indications for further development, including potential fast-to-market settings, thereby focusing its clinical investments in areas of greatest potential return, mitigating overall development risk and maximizing market opportunities; evaluation of its proprietary library of compounds to identify potential candidates for pre-clinical development; pursuit of partnerships or alliances with pharmaceutical and biotechnology companies, as well as research institutions and independent investigators, to offset spending, balance risk, and gain expertise; maintenance and expansion of its portfolio of patents, know-how and trade secrets; and commercialization or co-commercialization of its drugs in the U.S. Intellectual Property With respect to its AKT and fibroblast growth factor receptor (FGFR) programs, the company has issued patents and pending patent applications in the U.S., the E.U. and other foreign jurisdictions. For its AKT program, the company has four issued patents in the U.S. covering composition of matter for its lead AKT compounds. The expiration dates of these patents range from December 2031 to June 2032. The company also has granted patents in the E.U., New Zealand and South Africa. For its FGFR program, the company has one issued patent in the U.S. covering composition of matter for its lead FGFR compounds. The company also has granted patents in Australia, Israel, Taiwan, the Philippines, Mexico and South Africa. ‘ArQule’, the ArQule logo, and ‘AKIP’ are trademarks of the company that are registered in the U.S. and other jurisdictions with applications pending in approximately 20 countries. History ArQule, Inc. was founded in 1993. The company was incorporated as a Delaware corporation in 1993.
arqule inc (ARQL:NASDAQ GM)
One Wall Street
Burlington, MA 01803
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