For Immediate Release
ArQule, Inc.
Daiichi Sankyo, Co., Ltd.
Daiichi Sankyo To License ARQ 092 from ArQule, the First New Compound Resulting from the Companies’ Joint AKIP Research Collaboration
ARQ 092 Will Soon Enter Phase 1 Clinical Trial
Woburn, MA and Tokyo, Japan (November 10, 2011) – ArQule, Inc. (NASDAQ: ARQL) and Daiichi Sankyo, Co. Ltd. (TSE 4568) announced today the execution of a license agreement for the development of a new AKT inhibitor called ARQ 092, the first compound to emerge from the companies’ November 2008 agreement to collaborate on research utilizing the AKIP™ (ArQule Kinase Inhibitor Platform) technology to generate novel, selective and potent small molecule kinase inhibitors. Under the license agreement, Daiichi Sankyo will obtain exclusive rights for development, manufacturing and marketing of ARQ 092 on a worldwide basis.
ARQ 092 will be studied in cancer patients to identify its utility in targeting the AKT signaling pathway, which plays a role in regulating cell growth, survival, migration and angiogenesis, and is frequently deregulated in cancer. Patient enrollment in the Phase 1 clinical trial with ARQ 092 is scheduled to open in the coming months.
“ARQ 092 is a potent, selective AKT inhibitor that has been optimized through a structure-based drug design methodology developed by ArQule scientists,” said Dr. Thomas C.K. Chan, chief scientific officer of ArQule. “This clinical candidate is the result of close scientific collaboration between the two companies over the past two and a half years.”
“The ARQ 092 collaboration builds on the success of our other partnerships with ArQule, including the co-development of our c-MET inhibitor, tivantinib, which is currently being studied in a Phase 3 trial as a treatment for non-squamous, non-small cell lung cancer,” said Dr. Kazunori Hirokawa, global head of the R&D Unit of Daiichi Sankyo. “In addition to our own internal R&D capabilities, our strategic alliance partnerships, such as our collaborations with ArQule, allow us to combine forces to move more programs into clinical trials toward our common goal of improving and extending lives.”
About the ArQule Kinase Inhibitor Platform (AKIPTM)
Kinases play pivotal roles in modulating diverse cellular activities and have been implicated as important mediators of certain forms of cancer and other diseases. The AKIP™ technology is based on a novel binding mode that leads to inhibition of target kinases by small molecules that do not compete with adenosine triphosphate (ATP) for binding. ArQule has identified more than 200 human kinases involved in multiple therapeutic areas that are amenable to such non-ATP competitive inhibition.
ArQule's ability to rationally design novel kinase inhibitors that encompass new chemical spaces allows for an expanding intellectual property estate. The Company believes that non-ATP competitive small molecule inhibitors may have fewer off-target side effects and may have utility in treating a broad range of human diseases.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-Met receptor tyrosine kinase. The Company’s pipeline consists of ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and ARQ 736, designed to inhibit the RAF kinases. ArQule’s current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit www.daiichisankyo.com
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