Last $1.32 USD
Change Today -0.04 / -2.94%
Volume 118.8K
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As of 2:20 PM 11/28/14 All times are local (Market data is delayed by at least 15 minutes).
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Company Description

Contact Info

19 Presidential Way

Woburn, MA 01801

United States

Phone: 781-994-0300

Fax: 781-376-6019

ArQule, Inc., a clinical-stage biotechnology company, is engaged in the research and development of cancer therapeutics. The company’s drugs target biological pathways implicated in a range of cancers. It employs technologies, such as its ArQule Kinase Inhibitor Platform (AKIP) to design and develop drugs. Product Candidates Tivantinib (ARQ 197) The company’s lead product candidate is tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase (c-MET or MET) and its biological pathway. C-MET is a promising target for cancer therapy, based on its multiple roles in cancerous cell proliferation, tumor spread, new blood vessel formation and resistance to certain drug therapies. The company and its partners, Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) and Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), are implementing a worldwide clinical development program designed to realize the potential of tivantinib as a single agent and in combination with other anti-cancer therapies. The company is developing its tivantinib with Daiichi Sankyo in the U.S., Europe, South America and the rest of the world, excluding Japan and certain other Asian countries, where the company has licensed commercial rights to Kyowa Hakko Kirin Co., Ltd. Earlier Clinical Stage Product Candidates Proprietary Pipeline: ARQ 092, ARQ 087 and ARQ 761 The company’s proprietary early clinical-stage product pipeline is directed toward molecular targets and biological processes with demonstrated roles in the development of human cancers. Its priorities within this pipeline include ARQ 092, an Akt inhibitor for which the company regained development and commercialization rights from Daiichi Sankyo in 2013; ARQ 087, a multi-kinase inhibitor with pan-FGFR activity; and ARQ 761, which is being investigated as a potential NQ01 inhibitor. Following an analysis of Phase 1 data and the related therapeutic landscapes of its other pipeline candidates, which include ARQ 621, an inhibitor of the Eg5 kinesin motor protein; and ARQ 736, an inhibitor of the RAF kinases, the company has placed the Investigational New Drug applications for these compounds on inactive status. The company intends to complete ongoing Phase 1 trials with ARQ 092 and ARQ 087 in 2014. It is supporting an ongoing investigator-sponsored study with ARQ 761. The company’s strategy with these product candidates is to generate pre-clinical and early clinical data that would inform decisions regarding possible initiation of Phase 2 testing with one or more of them either independently or on a partnered basis. Strategy The company’s strategy is to focus on the most promising indications within its clinical programs based upon continually generated and updated clinical and pre-clinical data. Its strategy is to build an integrated, commercial-stage biotechnology company that discovers, develops, manufactures, markets, and sells safe, innovative, and effective small molecule drugs, in the field of oncology. The company’s development and commercialization strategy includes various components, such as improving organically and through business development; focusing on cancer, a market with a large unmet need; utilizing its AKIP discovery technology; and benefiting from the resources and strengths of collaborators. Patents and Proprietary Rights For the company’s MET program, the company has two issued patents in the U.S. covering the composition of matter of tivantinib. The U.S. Patent and Trademark Office has determined that the term of the initial patent would be adjusted beyond its normal expiration date of February 2026 to March 2029 (and in addition, there is the possibility of a patent term extension based upon regulatory review) and the second patent would be adjusted beyond its normal expiration date of February 2026 to December 2026. The company has issued patents from the Republic of Korea, the Republic of Singapore, Australia, the People’s Republic of China, the E.U., Japan, Israel, Mexico, New Zealand, the Philippines, Russia, Canada, Albania, Hong Kong, Indonesia, Malaysia, Norway and South Africa for composition

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