Lilly has entered into an agreement with Glenmark Pharmaceuticals S.A., a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, to acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain.

Glenmark will receive an upfront fee of $45 million and could receive as much as $215 million more in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones of as much as $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. Glenmark will also have the right to co- promote GRC 6211 in the U.S. Other terms of the deal were not disclosed.

"This agreement is further evidence of Lilly's commitment to seek out novel treatments for important medical conditions, such as osteoarthritic pain," commented William Chin, M.D., Lilly vice president, discovery research and clinical investigation. "We believe that TRPV1 represents a promising pathway for pain research. GRC 6211 has shown good potential in early-phase development and will be a strong addition to our own internal pipeline of potential pain molecules."

According to Glenn Saldanha, Managing Director and CEO of GPL, "This agreement further validates that Indian companies have the ability to do world class innovative R&D and Glenmark's leadership in the Indian drug discovery arena. We have made excellent progress in our TRPV1 program at Glenmark and are very excited to be partnering with Lilly, a world-class research-driven global pharmaceutical company."

Pfizer has nominated a second compound for clinical development in its collaboration with Coley Pharmaceutical Group. Coley is developing a novel class of drug candidates known as TLR Therapeutics. This second generation drug candidate is expected to complement Pfizer's ongoing clinical programs for PF-3512676, Coley's lead therapeutic TLR9 agonist drug candidate, for the treatment of cancer.

Under the agreement, Pfizer has exclusive rights to two novel compounds discovered in the collaboration, while Coley retains the rights to all other molecules. To date, Coley has designed and characterized nearly 60 unique compounds, each of which elicits a distinct immune stimulatory profile based on its interaction with TLR9. The newly nominated compound, which is the first of two development candidates, will now undergo preclinical studies to further assess its pharmacokinetic and toxicology profiles before advancing into clinical trials.

Pfizer is currently investigating PF-3512676 in combination with non-cytotoxic anti-cancer agents. A Phase II clinical trial evaluating PF-3512676 in combination with Tarceva for the treatment of refractory non-small cell lung cancer, and a Phase I clinical trial evaluating PF-3512676 in combination with Pfizer's anti-CTLA4 antibody, tremelimumab, for the treatment of advanced melanoma are both underway. Pfizer is currently planning additional clinical trials with PF-3512676 to evaluate its safety and potential efficacy in other cancer indications.

MDS Pharma Services has moved its central lab services to a new, larger facility in Beijing to meet growing demands from pharmaceutical and biotech companies conducting clinical trials in China.

With almost 25,000 sq. ft., the new facility offers a fivefold increase in testing capacity, four times the space to produce clinical trial kits, and a wider range of specialized clinical trial testing services, according to MDS. This new facility's proximity to the Beijing airport also facilitates faster transportation of clinical trial samples.

Said MDS Pharma Services president David Spaight, "With many pharmaceutical and biotech companies now making China part of their global clinical trial programs, we recognized the need to expand our central lab operations and offer more diverse testing options."

This new central lab facility specializes in molecular biology testing for infectious diseases, DNA banking and pharmacogenomics. It also offers enhanced molecular biology techniques, a microbiology lab and flow cytometry capabilities. MDS Pharma Services continues to offer project and data management from this new facility.

The company has been in China for more than 10 years, and was the first western CRO to own its facility in China.

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