Partnership is primed and ready

FivePrime Therapeutics partners with GSK on skeletal muscle disorders

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SAN FRANCISCO—FivePrime Therapeutics Inc., a biologics developer, announced in early August a strategic drug discovery alliance with global pharma giant GlaxoSmithKline (GSK).

FivePrime is a clinical-stage, privately held biotechnology company discovering and developing innovative protein and antibody therapeutics. FivePrime is currently testing FP-1039, a first-in-class biologic, in a Phase I study for patients with solid tumors. Using its biologics discovery platform, it has built a unique suite of technologies to mine the entire extracellular human proteome for medically relevant therapeutic protein drugs.  
The new collaboration allows GSK access to FivePrime's drug discovery platforms specifically in the areas of sarcopenia, cachexia and other skeletal muscle disorders.

Under the terms of the agreement, GSK will receive access to FivePrime's comprehensive proprietary collection of secreted proteins and transmembrane receptor proteins. FivePrime will conduct high-throughput in vitro and in vivo assays customized to identify potential drug targets and drug candidates for treating skeletal muscle diseases. GSK will have an option to exclusively license each drug target or drug candidate discovered by FivePrime from the collaboration and take on sole responsibility for additional preclinical studies, clinical development, manufacturing and worldwide commercialization.

"Our three core areas," says Julia Gregory, president and CEO of FivePrime, "are oncology, immunology and metabolic disorders. We have a rich pipeline and discovery platform that gives us potential in multiple areas."

FivePrime will receive approximately $15 million in 2010 in an upfront fee, the purchase of FivePrime equity by GSK and payments related to the research program. In addition, FivePrime is eligible for additional research program payments in 2011 to 2013, and up to $124 million in potential option exercise fees and milestone payments, as well as tiered royalties on global net sales for each product resulting from a selected drug target or drug candidate.

The partnership, according to Gregory, started from "ground zero" in July, and is in the discovery phase, with the relevant assays being built to apply to FivePrime's library to identify likely drug candidates.

"We're at the very beginning of a three-year collaboration," Gregory adds.

Gregory that global markets have not yet been identified; that will be the responsibility of GSK as products come to market.

"We are delighted to form this strategic alliance with GSK and harness the power of our unique extracellular proteome library and drug discovery technologies to find new drugs and drug targets for disorders of skeletal muscle," says Dr. Lewis T. "Rusty" Williams, executive chairman and founder of FivePrime.

Gregory says the key to FivePrime's success lay in the fact that the company, which was founded in 2002, chose to analyze the practices of other companies in the same space, and determined that FivePrime would build a complete library of all of the human body's secreted proteins and extracellular receptors and then screen them in state-of-the-art, medically relevant, cell-based in vivo assays.

GSK representatives declined to comment for this story; instead, they referred questions to FivePrime.

Gregory indicates that GSK and the 115-employee FivePrime have known each other for many years, and have been in frequent communication. She says that her company has a strong scientific advisory board of industry leaders and Nobel laureates, which is complemented by an equally strong investor board.

She adds that GSK is a world leader in addressing skeletal muscular disorders, which is one of FivePrime's areas of focus.

"Collaborating with GSK will direct additional resources toward accelerating the development of novel drugs for patients suffering from sarcopenia, cachexia and other skeletal muscle disorders that are not well served today," adds Gregory. "We are pursing other partnerships as well, of both types—drug discovery and product collaborations. It's a partnership world out there today. Our goal is to be successful for our partners as well as ourselves."

Sarcopenia is the loss of skeletal muscle mass that accompanies normal aging and accelerates later in life. Approximately 7 percent of men and 10 percent of women age 60 or older are afflicted with severe sarcopenia. Muscle cachexia is muscle atrophy that accompanies several chronic illnesses including cancer, AIDS, chronic obstructive lung disease, congestive heart failure and renal failure. Estimates are that up to 2 percent of the population suffers from precachexia, characterized by weight loss in association with a chronic disease.

According to Gregory, FivePrime is also in the midst of an existing relationship with Pfizer focusing on oncology and diabetes, and concluded an arrangement earlier this year with Centocor. That pact involved pulmonary disease and osteoarthritis, and resulted in Centocor taking a therapeutic program into its own drug development pipeline.

GlaxoSmithKline and Amplimmune form global cancer collaboration

ROCKVILLE, Md.—GlaxoSmithKline PLC (GSK) announced in early August another partnership, this one with Amplimmune Inc., a developer of novel biologics that are key co-stimulatory/co-inhibitory molecules to rebalance the immune system. The collaboration will focus primarily on the development of AMP-224, Amplimmune's Fc-fusion protein of the B7-DC ligand (also known as PD-L2), which targets PD-1, which plays a key role in regulating T-cell mediated immune responses. GSK will pay Amplimmune $23 million up front and up to $485 million in regulatory, development and sales milestone payments associated with IND filing and conducting a Phase 1 trial of AMP-224. Amplimmune may also receive up to double-digit royalties on global sales.

In vivo studies with AMP224 suggest that this product candidate can induce immune responses to tumors and pathogens sufficient to ameliorate disease.

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