INDIANAPOLIS and MUMBAI, India, Oct. 30 EliLilly and Company (NYSE: LLY) today announced that it has entered into anagreement with Glenmark Pharmaceuticals S.A. (GPSA) a wholly owned subsidiaryof Glenmark Pharmaceuticals Limited India (GPL). Under the terms of theagreement, Lilly will acquire the rights to a portfolio of transient receptorpotential vanilloid sub-family 1 (TRPV1) antagonist molecules, including aclinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase IIdevelopment as a potential next-generation treatment for various painconditions, including osteoarthritic pain.
Under the terms of the agreement, Glenmark will receive an upfront fee of$45 million and could receive up to an additional $215 million in potentialdevelopment and sales milestones for the initial indication, as well asroyalties on sales if GRC 6211 is successfully commercialized. If otherindications are successfully developed, Glenmark would be entitled toadditional milestones up to $90 million. Lilly will have marketing rights forNorth America, Europe and Japan, while Glenmark will retain the marketingrights in all other countries. Further Glenmark will have the right to co-promote GRC 6211 in the United States. Other terms of the deal were notdisclosed.
"This agreement is further evidence of Lilly's commitment to seek outnovel treatments for important medical conditions, such as osteoarthriticpain," commented William Chin, M.D., Lilly vice president, discovery researchand clinical investigation. "We believe that TRPV1 represents a promisingpathway for pain research. GRC 6211 has shown good potential in early-phasedevelopment and will be a strong addition to our own internal pipeline ofpotential pain molecules."
According to Glenn Saldanha, Managing Director and CEO of GPL, "Thisagreement further validates that Indian companies have the ability to do worldclass innovative R&D and Glenmark's leadership in the Indian drug discoveryarena. We have made excellent progress in our TRPV1 program at Glenmark andare very excited to be partnering with Lilly, a world-class research-drivenglobal pharmaceutical company."
The agreement became effective in the fourth quarter of 2007. At closing,Lilly would expect a charge to earnings for acquired in-process research anddevelopment. The amount of the charge has not yet been determined, but isestimated to be $0.02 per share. Lilly's fourth-quarter and full-year proforma adjusted earnings per share guidance remain unchanged at $0.86 to $0.91and $3.50 to $3.55, respectively. On a reported basis, including the chargefor this transaction with Glenmark, as well as the other charges in the tablesbelow, Lilly now expects its fourth-quarter earnings per share to be in therange of $0.81 to $0.86 and its full-year earnings per share to be in therange of $2.74 to $2.79. See the reconciliations below for further detail.
TRPV1 is a member of the TRPV family of ion channel proteins. It isexpressed in human pain pathways and in sensory neurons that mediatenociceptive signaling. Research on TRPV1 supports the potential forantagonists of this ion channel to be effective in various pain conditions.The goal of the partnership is to advance GRC 6211 and other promising drugcandidates to ultimately provide novel therapies for painful conditions andother diseases and disorders.
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers - through medicines and information- for some of the world's most urgent medical needs. Additional informationabout Lilly is available at www.lilly.com.