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ArQule, Inc. (ARQL - Snapshot Report) recently announced that the company has regained global rights for the development and commercialization of compounds, which are covered under its AKT collaboration with Daiichi Sankyo Co., Ltd.

The compounds include candidate ARQ 092, which is currently in a phase I trial. We note that Daiichi Sankyo and ArQule entered into a license agreement for the development of ARQ 092 in Nov 2011.

As per the license agreement, Daiichi Sankyo had exclusive rights for the development, manufacturing and marketing of ARQ 092 on a global basis. In exchange, ArQule received a $10 million upfront payment from Daiichi Sankyo in Nov 2011 along with support for the ongoing phase I trial on ARQ 092.

ArQule gained back its rights to the AKT program and to ARQ 092 after Daiichi Sankyo decided to terminate the license and co-commercialization agreement.

ARQ 092 is a selective AKT inhibitor, which was invented from the proprietary ArQule Kinase Inhibitor Platform (AKIP). ArQule uses AKIP technology to design and develop cancer drugs.

Apart from ARQ 092, ArQule’s pipeline also includes oncology candidate ARQ 197 (tivantinib).

In Jan 2013, ArQule and partner Daiichi Sankyo initiated a phase III METIV-HCC -- MET-high patients with tivantinib in hepatocellular carcinoma (HCC) -- trial on ARQ 197.

The study is evaluating the candidate for the treatment of patients suffering from HCC who have previously received one or two prior systemic anti-cancer therapies. The primary endpoint of the trial is overall survival (OS) while the secondary endpoint is progression-free survival.

ArQule currently carries a Zacks Rank #3 (Hold). Pharma stocks that currently look well placed are Furiex Pharmaceuticals Inc , Avanir Pharmaceuticals (AVNR - Analyst Report) and Biodel Inc (BIOD - Snapshot Report).

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