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Array BioPharma Achieves $10 Million Clinical Milestone in MEK162 Oncology Program
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Press Release Source: Array BioPharma On Thursday April 7, 2011, 8:30 am EDT
BOULDER, Colo.--(BUSINESS WIRE)-- Array BioPharma Inc. (NASDAQ:ARRY - News) announced today that a $10 million clinical research milestone was achieved in its development collaboration with Novartis. Array entered into an agreement with Novartis in April 2010 for the worldwide development of the small-molecule MEK inhibitors MEK162 (ARRY-162), its back-up, ARRY-300, and other MEK inhibitors. The milestone was achieved after Novartis had its first patient visit in a Phase 2 clinical trial.
The Phase 2 trial is an open-label study to assess the safety and efficacy of MEK162 in patients with malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations. The trial is designed to measure the objective response rate to treatment with MEK162 when administered orally as 45 mg twice-daily to patients. The trial will also evaluate progression-free survival, safety and tolerability.
Under the terms of the agreement with Novartis, Array received initial payments of $45 million. After payment of the $10 million milestone, Array is eligible to receive an additional $412 million if certain clinical, regulatory and commercial milestones are achieved. In addition, Array is co-developing MEK162 with Novartis in one or more specific indications and funding a portion of development costs. The agreement provides Array with royalties on sales of approved drugs outside of the U.S., with a higher royalty rate for U.S. sales provided that Array meets its co-funding obligations. Array also has a co-detailing right in the U.S. for approved drugs.
About MEK
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 frequently activated in cancer, in particular in tumors that have mutations in the RAS and RAF pathways.
About MEK162 (ARRY-162) / MEK inhibitor for cancer
MEK162 has been well-tolerated, displayed favorable pharmacokinetic properties, and demonstrated significant pharmacodynamic responses in the completed and ongoing clinical trials. In addition, Array has completed long-term preclinical regulated safety studies for MEK162. Array has completed or is enrolling patients with solid tumors in an ongoing multi-arm Phase 1 dose escalation and expansion trial. The dose escalation trial and the first expansion arm in patients with biliary tract cancer completed enrollment. Array is also currently enrolling patients with KRAS-mutant colorectal cancer and BRAF-mutant colorectal cancer in additional expansion arms of this trial. Novartis is currently enrolling patients with BRAF-mutant or NRAS-mutant melanoma in a Phase 2 open label trial.
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