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ArQule Regains Worldwide Rights to AKT Program

  ArQule Regains Worldwide Rights to AKT Program

Encouraging Phase 1 data with lead compound, ARQ 092, to be presented at AACR

Business Wire

WOBURN, Mass. -- April 1, 2013

ArQule, Inc. (NASDAQ: ARQL) today announced it has regained worldwide rights
for the development and commercialization of compounds covered under its AKT
collaboration with Daiichi Sankyo Co., Ltd., including the lead compound
emerging from this collaboration, ARQ 092. Data from an ongoing Phase 1 trial
with ARQ 092 will be presented at the AACR (American Association for Cancer
Research) Annual Meeting on April 9, 2013.

“Regaining worldwide rights to the AKT program, including the novel oral
agent, ARQ 092, adds significant value for ArQule, as it expands our
proprietary pipeline in an exciting area of therapeutic development,” said
Brian Schwartz, M.D., chief medical officer of ArQule. “AKT, also known as the
serine/threonine kinase PKB, is believed to mediate a number of signal
transduction processes and represents a potential therapeutic target for
several cancers and other diseases. We look forward to the AACR data
presentation from the ongoing Phase 1 trial with ARQ 092.”

ARQ 092 is a selective AKT inhibitor that was discovered through technology
from the ArQule Kinase Inhibitor Platform (AKIP™) and optimized through a
structure-based drug design methodology. The AKT signaling pathway, which
plays a role in regulating cell growth, survival, migration and angiogenesis,
is frequently dysregulated in cancer.

ArQule is regaining its rights to the AKT program and to ARQ 092 pursuant to
Daiichi Sankyo’s decision to terminate a license and co-commercialization
agreement with ArQule dated November 8, 2011.

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 092, designed to inhibit AKT, ARQ 087, designed to inhibit
fibroblast growth factor receptor (FGFR), 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.

This press release contains forward-looking statements regarding the Company’s
clinical trials with ARQ 092, which is in Phase 1 clinical development. These
statements are based on the Company’s current beliefs and expectations, and
are subject to risks and uncertainties that could cause actual results to
differ materially. Positive information about pre-clinical and early stage
clinical trial results does not ensure that later stage or larger scale
clinical trials will be successful. For example, ARQ 092 may not demonstrate
promising therapeutic effects; in addition, it may not demonstrate an
appropriate safety profile in current or later stage or larger scale clinical
trials as a result of known or as yet unanticipated side effects. The results
achieved in later stage trials may not be sufficient to meet applicable
regulatory standards or to justify further development. Problems or delays may
arise during clinical trials or in the course of developing, testing or
manufacturing ARQ 092 that could lead the Company to discontinue development.
Even if later stage clinical trials are successful, unexpected concerns may
arise from analysis of data or from additional data. Obstacles may arise or
issues may be identified in connection with review of clinical data with
regulatory authorities, and regulatory authorities may disagree with the
Company’s view of the data or require additional data or information or
additional studies. In addition, the planned timing of initiation and
completion of clinical trials for ARQ 092 are subject to the ability of the
Company to enroll patients, enter into agreements with clinical trial sites
and investigators, and overcome other technical hurdles and issues related to
the conduct of the trials for which each of them is responsible that may not
be resolved. Drug development involves a high degree of risk. Only a small
number of research and development programs results in the commercialization
of a product. Positive pre-clinical data may not be supported in later stages
of development. Furthermore, ArQule may not have the financial or human
resources to successfully pursue drug discovery in the future. For more
detailed information on the risks and uncertainties associated with the
Company’s drug development and other activities, see the Company’s periodic
reports filed with the Securities and Exchange Commission. The Company does
not undertake any obligation to publicly update any forward-looking
statements.

Contact:

ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/Corp. Communications
www.ArQule.com
 
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