WHITEHOUSE STATION, N.J.—Endocyte Inc. and Merck, also knownas MSD outside of the United States and Canada, have announced an agreement forthe development and commercialization of Endocyte's novel investigationaltherapeutic candidate vintafolide, or EC145. The drug candidate is currentlyundergoing evaluation in a Phase III clinical trial for the treatment ofplatinum-resistant ovarian cancer and a Phase II trial for the treatment ofnon-small cell lung cancer. Both studies are also utilizing etarfolatide, aninvestigational companion diagnostic agent from Endocyte. The non-invasiveimaging agent is used for the identification of folate receptor positive cells.
"Following a rigorous selection process we believeMerck represents the ideal strategic partner to achieve the full potential ofvintafolide, accelerating our development in numerous cancers," Ron Ellis,president and CEO of Endocyte, said in a press release. "The agreementalso positions us well to build our own commercial infrastructure for vintafolidein the U.S. and for etarfolatide worldwide."
Per the terms of the agreement, Merck will gain, through asubsidiary, worldwide rights to develop and commercialize vintafolide, forwhich it will pay $120 million upfront. In addition, Endocyte is eligible toreceive up to $880 million in milestone payments if certain development,regulatory and commercialization goals for vintafolide are achieved for a totalof six cancer indications. If the drug candidatesecures regulatory approval, Endocyte will also receive an equal share of theprofit in the United States as well as a double-digit percentage royalty onproduct sales in the rest of the world.
Endocyte will have the right to co-promote in the UnitedStates, though Merck holds exclusive rights for promotion in the rest of theworld. The majority of funding and completion of the PROCEED trial, the PhaseIII trial of vintafolide, will fall to Endocyte, and Merck will be responsiblefor all other development activities and costs and will have all decisionrights for the drug candidate. Endocyte will be responsible for thedevelopment, manufacture and worldwide commercialization of etarfolatide.
"Vintafolide is a promisingand innovative late-stage cancer drug candidate. In addition to pursuing thelead indication of platinum-resistant ovarian cancer, Merck plans to furtherevaluate its potential for treatment of multiple other cancer types,"Peter S. Kim, executive vice president and president of Merck ResearchLaboratories, said in a statement. "This agreement underscores ourstrategy of building a portfolio of oncology therapeutics that employ acompanion diagnostic to facilitate selection of those patients most likely torespond to treatment."
To date, Endocyte has completed three single arm studies ofthe drug in patients with advanced platinum resistant ovarian cancer, non-smallcell lung caner and solid tumors. In a Phase II clinical trial of vintafolideplus pegylated liposomal doxorubicin (PLD) versus PLD alone in women withplatinum resistant ovarian cancer, vintafolide evinced a statisticallysignificant delay in disease progression or death. The largest improvement wasseen in patients with all tumors imaged as positive for folate receptorexpression utilizing Endocyte's companion diagnostic. When combined with PLD,vintafolide resulted in limited additional toxicity compared to PLD alone, andcommon adverse side effects of the combination were limited to fatigue, mouthsores, neutropenia and redness/swelling/pain in extremities.
Last month, the drug was granted orphan drug status by theEuropean Union, and Endocyte announced plans to file a marketing authorizationapplication in the third quarter of this year.
SOURCE: Endocyte Inc. press release
