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Array BioPharma Initiates Phase 1 Clinical Trial for MEK Inhibitor ARRY-300

BOULDER, Colo.--(BUSINESS WIRE)--Jan. 9, 2009--Array BioPharma Inc. (NASDAQ: ARRY) has initiated dosing in healthy volunteers in a Phase 1 clinical trial with ARRY-300, a targeted small molecule MEK inhibitor.

The Phase 1 clinical trial is a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of orally administered ARRY-300 in healthy volunteers.

"We believe ARRY-300 is a best-in-class MEK inhibitor with superior pharmacologic properties compared to other MEK inhibitors currently in clinical development," said Kevin Koch, Ph.D., President and Chief Scientific Officer. "Initially, we plan to test ARRY-300 in healthy volunteers to evaluate its safety, pharmacokinetics and pharmacodynamics."

About MEK Inhibition

MEK is an enzyme that regulates the biosynthesis of the inflammatory cytokines TNF, IL-6 and IL-1. MEK also plays a key position in the Ras/Raf/MEK/ERK signaling pathway, which has been implicated in the development and progression of cancers. Array scientists have discovered potent MEK inhibitors that interfere with these biosynthetic processes. Array's first MEK inhibitor, AZD6244 (ARRY-886), which was licensed to AstraZeneca in 2003, is currently in Phase 2 clinical development for the treatment of cancer. Array's wholly-owned MEK inhibitor, ARRY-162, is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis. Given Array's experience with the safety profile of MEK inhibitors, it believes inhibition of MEK will have broad applications in diseases driven by IL-1 and TNF, including rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), inflammatory bowel disease (IBD). Recently published preclinical data have shown that MEK inhibitors have potent activity in certain resistant tumor types, especially in combination with other therapies that target the PI3K / AKT pathway.

About Array BioPharma

Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, inflammatory and metabolic diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.com.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our future plans for advancing certain of our proprietary drug programs, the potential to earn future milestone payments, license fees or royalty revenue, and the plans of our collaborators to further develop drugs we have out-licensed or on which we are collaborating. These statements involve significant risks and uncertainties, including those discussed in our annual report filed on form 10-K for the year ended June 30, 2008, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet objectives tied to milestones and royalties, and our ability to attract and retain experienced scientists and management. We are providing this information as of January 9, 2009. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

CONTACT: Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com

Source: Array BioPharma Inc.