Merck, Endocyte ink agreement for cancer drug candidate
WHITEHOUSE STATION, N.J.—Endocyte Inc. and Merck, also known as MSD outside of the United States and Canada, have announced an agreement for the development and commercialization of Endocyte's novel investigational therapeutic candidate vintafolide, or EC145. The drug candidate is currently undergoing evaluation in a Phase III clinical trial for the treatment of platinum- resistant ovarian cancer and a Phase II trial for the treatment of non-small cell lung cancer. Both studies are also utilizing etarfolatide, an investigational companion diagnostic agent from Endocyte. The non-invasive imaging agent is used for the identification of folate receptor positive cells.
"Following a rigorous selection process we believe Merck represents the ideal strategic partner to achieve the full potential of vintafolide, accelerating our development in numerous cancers," Ron Ellis, president and CEO of Endocyte, said in a press release. "The agreement also positions us well to build our own commercial infrastructure for vintafolide in the U.S. and for etarfolatide worldwide."
Per the terms of the agreement, Merck will gain, through a subsidiary, worldwide rights to develop and commercialize vintafolide, for which it will pay $120 million upfront. In addition, Endocyte is eligible to receive up to $880 million in milestone payments if certain development, regulatory and commercialization goals for vintafolide are achieved for a total of six cancer indications. If the drug candidate secures regulatory approval, Endocyte will also receive an equal share of the profit in the United States as well as a double-digit percentage royalty on product sales in the rest of the world.
Endocyte will have the right to co-promote in the United States, though Merck holds exclusive rights for promotion in the rest of the world. The majority of funding and completion of the PROCEED trial, the Phase III trial of vintafolide, will fall to Endocyte, and Merck will be responsible for all other development activities and costs and will have all decision rights for the drug candidate. Endocyte will be responsible for the development, manufacture and worldwide commercialization of etarfolatide.
"Vintafolide is a promising and innovative late-stage cancer drug candidate. In addition to pursuing the lead indication of platinum-resistant ovarian cancer, Merck plans to further evaluate its potential for treatment of multiple other cancer types," Peter S. Kim, executive vice president and president of Merck Research Laboratories, said in a statement. "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."
To date, Endocyte has completed three single arm studies of the drug in patients with advanced platinum resistant ovarian cancer, non-small cell lung caner and solid tumors. In a Phase II clinical trial of vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum resistant ovarian cancer, vintafolide evinced a statistically significant delay in disease progression or death. The largest improvement was seen in patients with all tumors imaged as positive for folate receptor expression utilizing Endocyte's companion diagnostic. When combined with PLD, vintafolide resulted in limited additional toxicity compared to PLD alone, and common adverse side effects of the combination were limited to fatigue, mouth sores, neutropenia and redness/swelling/pain in extremities.
Last month, the drug was granted orphan drug status by the European Union, and Endocyte announced plans to file a marketing authorization application in the third quarter of this year.
SOURCE: Endocyte Inc. press release