HGSI, FivePrime enter agreement to develop, commercialize FP-1039 for multiple cancers

Human Genome Sciences, Inc. (Nasdaq: HGSI) and FivePrime Therapeutics, Inc. announced today that they have entered into an agreement to develop and commercialize FivePrime's FP-1039 product for multiple cancers. FP-1039 is a first-in-class biologic discovered by FivePrime that targets multiple fibroblast growth factor (FGF) ligands. Under the terms of the agreement, HGS has acquired rights to develop and commercialize FP-1039 in the United States, Canada and the EU markets, while FivePrime retains minority co-promotion rights in the U.S. and full development and commercialization rights in rest of world territories, including Asia.

"Today's announcement underscores Human Genome Sciences' commitment to developing novel targeted therapies that address significant unmet medical needs for patients," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are excited to add FP-1039 to our pipeline and look forward to working with FivePrime to develop and commercialize this innovative biologic product."

Under the terms of the agreement, HGS will pay FivePrime an upfront license fee of $50 million and FivePrime will be eligible to receive up to $445 million in future development, regulatory and commercial milestone payments. The agreement calls for tiered double-digit percentage royalty payments on net sales. HGS has exclusive rights to develop and commercialize FP-1039 for all indications in the United States, Canada and the European Union. FivePrime has an option to co-promote FP-1039 and any next-generation products in the United States, and retains full development and commercialization rights in all other regions of the world outside the U.S., Canada and the EU, including Asia, Latin America and non-EU nations in Europe, including Russia. At FivePrime's request, HGS will supply FivePrime with FP-1039 for use in the rest of world territories.

"We are delighted to enter into this collaboration with HGS. It will significantly broaden the clinical plan for FP-1039, enabling us to address the multiple tumor types in which FP-1039 may have activity," said Julia P. Gregory, President and Chief Executive Officer of FivePrime. "This strategically important collaboration evidences the rapidly growing excitement surrounding novel oncology drugs."

"FivePrime's valuable discovery platforms have enabled us to develop a very promising therapeutic agent in a signaling pathway that has been historically untapped for drug development. HGS is a great partner for FP-1039 because of their track record of success in developing breakthrough biologics," stated Lewis T. Williams, M.D. Ph.D., Executive Chairman and Founder of FivePrime.

FP-1039 is being evaluated in an ongoing phase 1 clinical study in which it has been shown to be safe and well tolerated to date. Patients are currently being screened for a phase 2 trial for a form of endometrial cancer.