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Boulder-based Array (Nasdaq: ARRY) licensed rights to develop and commercialize the drug — called MEK162 — to Novartis (NYSE: NVS) in April 2010. The planned 2013 ‘pivotal trial,’ as it is called by the companies, is generally seen as the last step needed in a strict approval process required by the U.S. Food and Drug Administration. Novartis, based in Basel, Switzerland, expects to request regulatory approval for the drug in 2016, according to a press statement from the companies.
Array is co-developing MEK162 with Novartis. The drug addresses a particular mutation in skin cancer that occurs in about 15 percent to 20 percent of all skin-cancer patients.
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“We are pleased that Novartis is expected to advance MEK162 into pivotal trials next year,” Ron Squarer, Array BioPharmaís chief executive officer, said in the press statement. “Based on the positive Phase 2 trial results in NRAS mutant melanoma, MEK162 may provide a new option for patients with particularly poor prognoses.”
In a current Phase 2 drug trial of MEK162, the disease control rate is 67 percent, the companies said in the press statement.