Merck & Co. is paying Endocyte $120 million up front for worldwide rights to develop and commercialize the latter’s Phase III-stage folate receptor-targeting anticancer candidate vintafolide (EC145). Endocyte could receive up to another $880 million in milestone payments dependent on development, regulatory, and commercialization achievements for six cancer indications.
Vintafolide is currently being evaluated in a Phase III trial (Proceed) against platinum-resistant ovarian cancer and a Phase II trial in patients with non-small-cell lung cancer (NSCLC). Both studies are applying Endocyte’s investigational companion diagnostic agent etarfolatide (EC20), a folate-targeted molecular imaging agent in development as a noninvasive method for identifying tumors that overexpress folate receptors.
Under terms of the development deal Endocyte will primarily be responsible for funding and completing the Proceed trial, and Merck will take on all other development activities and costs. Endocyte will receive an equal share of profits in the U.S. and double-digit royalties on sales of the product in the rest of the world. The firm retains co-promotion rights to vintafolide in the U.S. and in addition remains responsible for the worldwide development, manufacture, and commercialization of the companion diagnostic etarfolatide.
“This agreement underscores our strategy of building a portfolio of oncology therapeutics that employ a companion diagnostic to facilitate selection of those patients most likely to respond to treatment,” says Peter S. Kim, evp and president of Merck Research Laboratories, commenting on the vintafolide deal. “In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for the treatment of multiple other cancer types.”
Endocyte is focused primarily on the development of folate-receptor-targeted small molecule drug conjugates (SMDCs) for the treatment of cancer and associated companion diagnostics. The firm’s clinical pipeline includes cancer-targeting compounds. Last month Endocyte confirmed that following discussions with the European drug regulator, it plans to submit conditional MAAs for EC145 and EC20 for the treatment of platinum-resistant ovarian cancer during the third quarter of 2012.
If conditional marketing authorization is granted, data from the Proceed trial will subsequently be submitted to serve as the confirmatory data required to convert conditional approval to regular marketing authorization for EC145 and EC20. Both the therapeutic and diagnostic imaging agent have been granted orphan drug status in Europe.