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No immunity for autoimmune disease
PLYMOUTH, Mich.—Pharmaceutical giant Merck & Co. Inc. recently announced an exclusive research collaboration with Lycera, for the purpose of discovering, developing and commercializing drug candidates with the potential to treat major autoimmune diseases.
"Autoimmune diseases continue to represent a significant unmet medical need globally," says Dr. Don Nicholson, vice president and head of worldwide discovery for Merck Research Laboratories' Respiratory and Immunology franchise. "Lycera has established a strong reputation for innovation in this area, and we look forward to working together to advance this program."
The arrangement states that Lycera will receive $12 million in upfront cash payments, as well as significant committed research funding. The company is also eligible to receive up to $295 million in research, development and regulatory milestones as long as multiple major indications are approved. In addition, Lycera is entitled to up to low double-digit tiered royalty payments and sales milestones on global sales from any products that are developed as a result of the collaboration. Merck will be responsible for clinical development and will hold worldwide marketing and commercialization rights to any resulting products, although Lycera will retain a profit share option in the United States to all products that result from the collaboration.
"We are delighted to be working with Merck, which brings industry-leading expertise in drug discovery, development and commercialization to this collaboration," says Dr. Gary D. Glick, Lycera's founder and chief scientific officer. "This joint partnership is a significant validation of Lycera's discovery capabilities and our Th17 program, and enables us to expand the scope of our research in this promising area to expedite our discovery efforts as well as our timeline to enter the clinic."
Lycera, a biopharmaceutical company focused on developing oral medicines for the treatment of autoimmune diseases, will collaborate with Merck through an affiliate on the discovery of small-molecule candidates targeting the retinoic acid related orphan receptor (RORγt), which is the key transcription factor responsible for differentiation of T-helper (or Th17) cells. Th17 cells are a unique subset of CD4+T cells characterized by the production of interleukin-17 (IL-17), a highly inflammatory cytokine. IL-17 plays a central role in the pathogenesis of autoimmune diseases such as psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and asthma. Using its in-house developed assays, Lycera has been able to identify specific inhibitors of RORγt that can reduce IL-17 production.
"Work over the last several years with animal models has shown that IL-17 drives the pathogenesis for autoimmune diseases. Our approach, rather than targeting that cytokine, is to turn off the production of a range of cytokine," Glick explains. "The clinical validation, preclinical work and this strategy to affect the broad cell type, has a lot of potential."
Glick says Merck brings to the collaboration expertise in a number of areas, including a "storied history and current best in class ability to produce groundbreaking small-molecule drugs," as well as in biology and chemistry.
"They have an enormous amount of experience in inflammation," Glick asserts. "Their clinical development is second to none."
Dr. Julia Owens, senior vice president of corporate development and strategy at Lycera, adds that simply having a partnership in general is a bonus, as there can be "a much greater effort between two companies working together."
Glick notes that once they reach a certain point in the process, "Merck will take over regarding clinical development." He adds that the Th17 target may also have some importance in metabolic diseases, and that "there's been some work to suggest it may have applicability in oncology." Glick says the companies will be focusing on autoimmune diseases broadly, though he declines to comment on which disease or diseases they might be focusing on first.
"We certainly are working very hard and diligently together with the goal of producing first-in-class and best-in-class drugs to treat diseases that are unmet medical needs," Glick says regarding future potential commercialization.
Other pipeline developments for Lycera, according to Glick, include another molecule-focused program that originated in the company's lab at the University of Michigan, and also expansion into related technology in the inflammation field. Ultimately, though, Glick says that they continue to aim at being "a leader in the discovery of small molecules for autoimmunity and inflammation."
"We're thrilled to be working with a company of the caliber of Merck. We've already started working together, and this will be a true scientific collaboration," says Glick.