Endocyte Anticipating Positive CHMP Opinion On Ovarian Cancer Drug/Diagnostic Combo
This article was originally published in The Pink Sheet Daily
Endocyte and Merck are preparing to launch a combo drug/diagnostic in folate receptor-positive platinum-resistant ovarian cancer, a condition with a very poor survival prognosis, later this year in the EU. Medical affairs staff are meeting with specialists to discuss how the diagnostic can target patients most likely to respond in pre-approval commercial efforts.
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Merck will acquire rights to develop and commercialize Endocyte’s vintafolide, in Phase III development for ovarian cancer, in exchange for $120 million upfront and up to $880 million in milestones.
The U.S. biotech, which went public last year, will file EC145 and a companion diagnostic for conditional approval in Europe in platinum-resistant ovarian cancer based on findings from four Phase I and Phase II trials in the third quarter.
Facing soaring legal costs stemming from its failed merger with Fresenius Kabi and burdened by substantial debt, Akorn elected to put itself up for sale earlier this year in order to help repay lenders. But the company has now defaulted on an agreement with its creditors after no bidder stepped up to the plate.