Array BioPharma inked a deal with Novartis for the worldwide development of the small molecule MEK inhibitor ARRY-162, currently in a Phase I cancer trial. The agreement also covers its back-up, ARRY-300, and other MEK inhibitors. Array will initially receive $45 million comprising an upfront and milestone fee.
The firm is eligible to get an additional $422 million if certain clinical, regulatory, and commercial milestones are achieved. Array plans on co-developing ARRY-162 in one or more indications and funding a portion of development costs.
Array will earn double-digit royalties on sales of approved drugs outside of the U.S. and a higher royalty rate for U.S. sales if it meets co-funding obligations. Array also has a co-detailing right in the U.S. for approved drugs.
“We believe ARRY-162 will benefit from the additional resources of a major pharmaceutical company to rapidly maximize its promise as a cancer treatment, both as a single agent and in combination therapy,” says Robert E. Conway, CEO, Array BioPharma.
MEK is a protein kinase in the RAS/RAF/MEK/ERK pathway, which signals cancer cell proliferation and survival. It has been shown to be frequently activated in cancer, in particular in tumors that have mutations in the RAS and RAF pathways, Array explains.
The company believes that ARRY-162 has advantages over other MEK inhibitors currently in development, including greater potency and improved safety and pharmacokinetics. The company reports that it has completed long-term preclinical regulated safety studies and has identified a commercially viable synthetic process and oral formulation for ARRY-162.
The molecule is currently in a Phase I, open-label, multiple-dose trial in which ARRY-162 will be given as daily oral doses to cancer patients with advanced solid tumors. The trial has established a maximum tolerated dose, and Array has initiated an expansion phase initially in biliary tract cancer patients.
Array’s cancer pipeline includes two Phase II candidates, one for solid tumors and the other for acute myelogenous leukemia and multiple myeloma. The firm also has a molecule in a Phase I breast cancer trial and another in a Phase I study as a treatment for myelodysplastic syndrome. The company also has a Phase II stage compound that is being evaluated in pain indications.