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ARRAY BIOPHARMA PHASE 3 MILO STUDY EVALUATING BINIMETINIB IN OVARIAN CANCER ENROLLING GLOBALLY


BOULDER, CO, UNITED STATES - May 13, 2014 - Array BioPharma Inc. (NASDAQ: ARRY) continues recruitment for its ongoing Phase 3 clinical study in patients with low-grade serous ovarian cancer (LGSOC). The multinational, randomized Phase 3 study, called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), will evaluate the effectiveness of the investigational MEK inhibitor, binimetinib (MEK162), in comparison to that of selected chemotherapies. The primary endpoint is progression-free survival and the key secondary endpoint is overall survival.

Initiated in June 2013, the MILO study is enrolling patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum. In the study, patients will receive either investigational study drug binimetinib or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan).

To learn more about the MILO study, patients and physicians can visit the study’s website www.themilostudy.com or Clinicaltrials.gov.

AboutMEK and Binimetinib (MEK162)

MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, which signals cancer cell proliferation and survival. MEK has been shown to be activated in several tumor types such as non-small cell lung cancer, melanoma, thyroid cancer and ovarian cancer. Binimetinib is a small-molecule MEK inhibitor that targets a key position in this pathway and is in Phase 3 development in a range of tumor types. Array invented binimetinib and in 2010 licensed worldwide rights to develop and commercialize the drug to Novartis. The MILO study, along with on-going Phase 3 studies of binimetinib in both NRAS- and BRAF-mutant melanoma, are conducted as part of the Novartis/Array co-development agreement.

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. Seven Phase 3 or pivotal studies are already in progress, or are planned to begin this year. These programs include the wholly-owned hematology drug, filanesib (ARRY-520) for multiple myeloma and two partnered cancer drugs, selumetinib (AstraZeneca) and binimetinib (MEK162 / Novartis). For more information on Array, please go to www.arraybiopharma.com

Array BioPharma 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 potential to earn future milestone and royalty payments under our agreement with Novartis, the potential for the results of ongoing preclinical and clinical trials to support regulatory approval or the marketing success of a drug candidate and future plans to progress and develop binimetinib. These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on form 10-K, in our quarterly reports filed on Form 10-Q, 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, the ability of our collaborators and of Array to meet objectives tied to milestones and royalties; risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates; our ability to continue to fund and successfully progress internal research and development efforts and to create effective, commercially viable drugs; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; 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; our ability to attract and retain experienced scientists and management. We are providing this information as of May 13, 2014. 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:     

Tricia Haugeto

(303) 386-1193

thaugeto@arraybiopharma.com

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