No immunity for autoimmune disease

PLYMOUTH, Mich.—Pharmaceutical giant Merck & Co. Inc.recently announced an exclusive research collaboration with Lycera, for thepurpose of discovering, developing and commercializing drug candidates with thepotential to treat major autoimmune diseases.

"Autoimmune diseases continue to represent a significantunmet medical need globally," says Dr. Don Nicholson, vice president and headof worldwide discovery for Merck Research Laboratories' Respiratory andImmunology franchise. "Lycera has established a strong reputation forinnovation in this area, and we look forward to working together to advancethis program."

The arrangement states that Lycera will receive $12 millionin 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 areapproved. In addition, Lycera is entitled to up to low double-digit tieredroyalty payments and sales milestones on global sales from any products thatare developed as a result of the collaboration. Merck will be responsible forclinical development and will hold worldwide marketing and commercializationrights to any resulting products, although Lycera will retain a profit shareoption in the United States to all products that result from the collaboration.

"We are delighted to be working with Merck, which bringsindustry-leading expertise in drug discovery, development and commercializationto this collaboration," says Dr. Gary D. Glick, Lycera's founder and chiefscientific officer. "This joint partnership is a significant validation ofLycera's discovery capabilities and our Th17 program, and enables us to expandthe scope of our research in this promising area to expedite our discoveryefforts as well as our timeline to enter the clinic."

Lycera, a biopharmaceutical company focused on developingoral medicines for the treatment of autoimmune diseases, will collaborate withMerck through an affiliate on the discovery of small-molecule candidatestargeting the retinoic acid related orphan receptor (RORγt), which is the keytranscription factor responsible for differentiation of T-helper (or Th17)cells. Th17 cells are a unique subset of CD4+T cells characterized by theproduction of interleukin-17 (IL-17), a highly inflammatory cytokine. IL-17plays a central role in the pathogenesis of autoimmune diseases such aspsoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel diseaseand asthma. Using its in-house developed assays, Lycera has been able toidentify specific inhibitors of RORγt that can reduce IL-17 production.

"Work over the last several years with animal models hasshown that IL-17 drives the pathogenesis for autoimmune diseases. Our approach,rather than targeting that cytokine, is to turn off the production of a rangeof cytokine," Glick explains. "The clinical validation, preclinical work andthis strategy to affect the broad cell type, has a lot of potential."

Glick says Merck brings to the collaboration expertise in anumber of areas, including a "storied history and current best in class abilityto produce groundbreaking small-molecule drugs," as well as in biology andchemistry.

"They have an enormous amount of experience ininflammation," Glick asserts. "Their clinical development is second to none."

Dr. Julia Owens, senior vice president of corporatedevelopment and strategy at Lycera, adds that simply having a partnership ingeneral is a bonus, as there can be "a much greater effort between twocompanies working together."

Glick notes that once they reach a certain point in theprocess, "Merck will take over regarding clinical development." He adds thatthe 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 befocusing on first.

"We certainly are working very hard and diligently togetherwith the goal of producing first-in-class and best-in-class drugs to treatdiseases that are unmet medical needs," Glick says regarding future potentialcommercialization.

Other pipeline developments for Lycera, according to Glick,include another molecule-focused program that originated in the company's labat the University of Michigan, and also expansion into related technology inthe inflammation field. Ultimately, though, Glick says that they continue toaim at being "a leader in the discovery of small molecules for autoimmunity andinflammation."

"We're thrilled to be working with a company of the caliberof Merck. We've already started working together, and this will be a truescientific collaboration," says Glick.