ROCKVILLE, Md.—Human Genome Sciences Inc. (HGS) andFivePrime Therapeutics Inc. announced March 16 that they have entered into anagreement to develop and commercialize FivePrime's FP-1039 product for multiplecancers.
FP-1039 is a first-in-class biologic discovered by FivePrimethat targets multiple fibroblast growth factor (FGF) ligands. FP-1039 is beingevaluated in an ongoing Phase I clinical study in which it has been shown to besafe and well tolerated to date. Patients are currently being screened for aPhase II trial for a form of endometrial cancer.
Under the terms of the agreement, HGS will pay FivePrime anupfront license fee of $50 million and FivePrime will be eligible to receive upto $445 million in future development, regulatory and commercial milestonepayments. The agreement calls for tiered, double-digit percentage royaltypayments on net sales. HGS has exclusive rights to develop and commercializeFP-1039 for all indications in the United States, Canada and the EuropeanUnion. FivePrime has an option to co-promote FP-1039 and any next-generationproducts in the United States, and retains full development andcommercialization rights in all other regions of the world outside the UnitedStates, Canada and Europe, including Asia, Latin America and non-European Unionnations in Europe, including Russia. At FivePrime's request, HGS will supplyFivePrime with FP-1039 for use in the rest of the world.
Under the terms of the agreement, HGS has acquired rights todevelop and commercialize FP-1039 in the United States, Canada and the Europeanmarkets, while FivePrime retains minority co-promotion rights in the UnitedStates and full development and commercialization rights in rest of worldterritories, including Asia.
Dr. Lewis T. Williams, executive chairman and founder ofFivePrime, says HGS is a great partner for FP-1039 because of the company'strack record of success in developing breakthrough biologics.
"FivePrime's valuable discovery platforms have enabled us todevelop a very promising therapeutic agent in a signaling pathway that has beenhistorically untapped for drug development," Lewis says.
H. Thomas Watkins, president and CEO of HGS, says theagreement "underscores Human Genome Sciences' commitment to developing noveltargeted therapies that address significant unmet medical needs for patients."
"We are excited to add FP-1039 to our pipeline and lookforward to working with FivePrime to develop and commercialize this innovativebiologic product," Watkins adds.