LEXINGTON, Mass.—August 14, 2007—EPIX Pharmaceuticals announced it has achieved an initial milestone in its agreement with GSK to identify lead candidates in three discovery-stage programs. The milestone will trigger a $3-million payment, which EPIX expects to occur within the next month. Says Dr. Hugh Cowley, head of GSK's CEEDD: "In addition to the PRX-03140 program in Alzheimer's disease, we are moving forward with EPIX to discover and develop GPCR candidates for the treatment of a variety of diseases. This marks an initial milestone in what we expect will be a long and productive collaboration."
LEXINGTON, Mass. -- GlaxoSmithKline and EPIX Pharmaceuticals announced in mid-December a worldwide multi-target strategic collaboration to discover, develop and market novel medicines targeting four G-protein coupled receptors (GPCRs) for the treatment of a variety of diseases. The first project will focus on EPIX's novel 5-HT4 partial agonist program, PRX-03140, which is in early-stage clinical trials for the treatment of Alzheimer's disease.
GPCRs are said to be the largest known class of molecular targets with proven therapeutic value. Of the top 50 selling drug worldwide, as identified by IMS, it is estimated that nearly 40 percent interact with GPCRs as their target proteins. A variety of well-known biological molecules, including neurotransmitters and hormones, can bind to GPCRs and trigger cellular processes involved in diseases such as obesity, cognition, depression and pain.
EPIX will receive total initial payments of $35 million, including $17.5 million through GSK's purchase of 3,009,027 shares of common stock, about 13% of EPIX's outstanding shares. In addition, EPIX will be eligible to earn potential milestones and opt-in fees of up to $1.2 billion based on the achievement of certain discovery, development, regulatory and commercial milestones across the four GPCR programs. EPIX will also receive tiered double-digit royalties on sales by GSK of all collaboration-developed products.
EPIX will be responsible for the discovery and development of small molecule drug candidates targeting four GPCRs, including PRX-03140 for the treatment of Alzheimer's disease, through to clinical proof of concept, at which point GSK will have an exclusive option to license each product for further development and commercialization on a worldwide basis. If GSK exercises the option to license EPIX's 5-HT4 partial agonist program, EPIX will retain the right to co-promote any products from that program in the United States.
"We are very pleased to enter into this collaboration with GSK, a world-class pharmaceutical company," states Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "This alliance will provide us with access to significant capital in the near and long term to support the ongoing development of PRX-03140 and three additional programs. Furthermore, the co-promotion option in this collaboration provides further opportunity for EPIX to build a sales force in the future."
On December 5, 2006, Dr. Kauffman notes, the company initiated a Phase 2a trial of PRX-03140 as monotherapy and in combination with Aricept® for the treatment of Alzheimer's disease. Results are expected in the second half of 2007.
The alliance with GSK will be conducted through its Center of Excellence for External Drug Discovery (CEEDD), which was formed to create small, independent and accountable R&D teams. In essence, the CEEDD will externalize a portion of the GSK pipeline; namely, from target to clinical proof of concept, by forming multiple risk-sharing/reward-sharing alliances. Maxine Gowen, Ph.D. Senior Vice President and head of CEEDD states that, "This alliance with EPIX again demonstrates the CEEDD's and GSK's commitment to accessing leading-edge innovation. We are very excited to be working with the EPIX team both on the existing 5HT4 program in Alzheimer's disease, a key disease area for GSK, and on other GPCR programs which will be initiated as part of this collaboration."