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Array To Regain Worldwide Rights To Binimetinib

- Array to receive up to $85 million upfront payment from Novartis -
- Novartis to conduct and/or substantially fund all ongoing and several planned clinical studies, including COLUMBUS, NEMO and MILO -
- Agreement subject to Novartis-GSK transaction close -
- Conference call to discuss transaction on Thursday, December 4, 2014 at 9:00 a.m. Eastern Time -

BOULDER, Colo., Dec. 3, 2014 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced that it has reached a definitive agreement with Novartis International Pharmaceutical Ltd. to regain full worldwide rights to binimetinib, a MEK inhibitor in three Phase 3 trials. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) on April 22, 2014, which are expected in the first half of 2015, and remain subject to regulatory approval. Array had previously granted Novartis worldwide exclusive rights to develop and commercialize binimetinib under a 2010 License Agreement, which will terminate and be superseded by a new set of agreements between the parties.

"Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array," said Ron Squarer, Chief Executive Officer, Array BioPharma. "Binimetinib is currently advancing in three Phase 3 clinical trials and, we expect to file for our first regulatory approval during the first half of 2016. With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients."

Novartis stated, "Binimetinib has demonstrated promising results for cancer patients across several different clinical trials. We are committed to supporting a successful transition to Array."

Terms of the Agreement Upon deal close, Array will receive up to $85 million and Novartis' global, exclusive license to binimetinib will terminate with all rights reverting to Array. Novartis has agreed to provide transitional regulatory, clinical development and manufacturing services as specified below and will assign to Array patent and other intellectual property rights it owns to the extent relating to binimetinib. All clinical trials involving binimetinib, including the COLUMBUS, NEMO and MILO pivotal trials, will continue to be conducted as currently contemplated.
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Source: press release, 12/03/14. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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Array BioPharma Initiates MEK162 Phase 3 MILO Study Triggering Milestone Payment

BOULDER, Colo., July 2, 2013 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) announced today that a $5 million milestone was achieved after the start of Array's Phase 3 clinical trial in patients with low-grade serous ovarian cancer (LGSOC).

The study, called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), is a multinational, randomized Phase 3 trial and will evaluate MEK162 against physician's choice of standard chemotherapy treatments in 300 patients with recurrent or persistent LGSOC following at least one prior platinum-based chemotherapy regimen and no more than three lines of prior chemotherapy regimens. The primary endpoint is progression-free survival, and the key secondary endpoint is overall survival.

"Array is pleased to initiate its first Phase 3 trial with the goal of helping women with low-grade serous ovarian cancer who have progressed on cytotoxics and have no other proven therapeutic options," said Ron Squarer, Chief Executive Officer, Array BioPharma. "We also look forward to Novartis initiating both the NRAS- and BRAF-mutant melanoma pivotal studies later this year."

Array invented MEK162 and licensed worldwide rights to develop and commercialize the drug to Novartis in April 2010. Novartis recently detailed plans to initiate Phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma. All three trials will be conducted as part of the Novartis/Array co-development agreement under which costs are capped annually and in total for Array.
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Source: press release, 7/02/13. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Approximately 300 patients from North America, Europe and Asia Pacific will be enrolled in this study.
Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01849874?term=MEK162&phase=2&rank=...

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Binimetinib (ARRY-162) Ovarian CancerOncologyOvarian CancerMEK protein kinase inhibitorMEK protein kinase

Mechanism of action: Binimetinib (ARRY-162), a SM-inhibitor, interferes with cancer cell proliferation by disruption of the Ras/Raf/MEK/ERK cell proliferation and survival pathway via small molecule inhibition of the MEK protein kinase.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-06-01 - 2016-12-31

Results:

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Array BioPharma Announces Decision To Discontinue MILO Study In Ovarian Cancer
BOULDER, Colo., April 1, 2016 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) announced today its decision to discontinue the MILO study, a Phase 3 trial of binimetinib for the treatment of patients with low-grade serous ovarian cancer. The decision to stop the study was made after a planned interim analysis showed that the Hazard Ratio for Progression Free Survival (PFS) crossed the predefined futility boundary. Top-line results from the study had been expected in 2017.

Array BioPharma. (PRNewsFoto/Array BioPharma Inc.)
Array will work with investigators to appropriately conclude the MILO study in a manner consistent with the best interest of each patient, while more detailed results will be shared with the scientific community in the future. All other ongoing studies of binimetinib, including the Phase 3 COLUMBUS (BRAF-mutant melanoma) and NEMO (NRAS-mutant melanoma) trials, are unaffected.

Victor Sandor, M.D., Chief Medical Officer of Array, said: "While we are disappointed by this outcome, the findings from MILO have no impact on the other studies of binimetinib, including the NEMO trial, which has already met its primary endpoint, and the COLUMBUS trial, which is designed to test a highly precedented combination of mechanisms in patients with BRAF-mutant melanoma."
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Source: press release, 4/01/16. http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArt...

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