Inflammation collaboration

Eli Lilly and Incyte strike worldwide license and collaboration deal for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor for inflammatory and autoimmune diseases

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INDIANAPOLIS—In December, Eli Lilly and Co. and Incyte Corp. announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain follow-on compounds, for inflammatory and autoimmune diseases.

Incyte is a Wilmington, Del.-based drug discovery and development company focused on developing proprietary small-molecule drugs for oncology, inflammation and diabetes.
Excited about the path-breaking potential of INCB28050, both companies are optimistic about the multimillion-dollar deal.

"In Lilly, we've secured a top-tier partner who shares our confidence in the therapeutic and commercial value of JAK inhibitors for inflammation," says Paul Friedman, Incyte's president and chief executive officer. "We're confident that Lilly is committed to rapidly advancing INCB28050 in rheumatoid arthritis and other chronic inflammatory diseases."

There are four known JAK enzymes: JAK1, 2, 3 and TYK2. These enzymes are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients.

INCB28050 is an orally available, potent and selective JAK1/JAK2 inhibitor that is currently in Phase II development as a treatment for rheumatoid arthritis, an autoimmune inflammatory condition that affects an estimated 1 percent of the world's population. Its treatment is described as a "significant unmet clinical need" by those close to the deal, as rheumatoid arthritis currently has no cure and is progressively debilitating. Past drug trials have shown INCB28050 to be well tolerated and effective.

Cytokines such as interleukin-6, -12, and -23 signal through the JAK pathway and are now known to be therapeutic targets in inflammatory diseases. Additional JAK-dependent cytokines have also been implicated in a number of inflammatory and autoimmune diseases suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions.

Under the terms of the agreement, Lilly will receive worldwide rights to develop and commercialize INCB28050 as an oral treatment for all inflammatory conditions. Incyte received an upfront payment of $90 million and is eligible for up to $665 million in additional compensation if certain developmental, regulatory and commercialization milestones are met. Incyte expects that the earliest it would consider exercising a co-development option would be in the second half of 2010.

"One of the reasons we selected Lilly as our partner was because of the co-development option, which significantly increases the royalty rate range," says Friedman.

Lilly declined to comment for this story, but said in a prepared statement that it shares Incyte's confidence in the potential of INCB28050.

"This new alliance with Incyte reinforces Lilly's commitment to expand our presence in inflammation and autoimmunity through the development of a new class of oral anti-inflammatory therapies," stated Dr. Eiry Roberts, Lilly's vice president of autoimmune product development. "We look forward to continuing the development of INCB28050 in rheumatoid arthritis and initiating additional clinical studies to help address the unmet patient needs from debilitating autoimmune and inflammatory diseases."

Incyte will retain the option to co-develop its JAK1/JAK2 inhibitors with Lilly on a compound-by-compound and indication-by-indication basis beginning at the initiation of Phase IIb development. Under the agreement, if Incyte elects to co-develop any compounds and/or indications, Incyte would be responsible for funding 30 percent of the associated future global development costs from the initiation of a Phase IIb trial. These future financial arrangements may include tiered, double-digit royalty payments on future global sales with rates ranging up to 20 percent if a product is successfully commercialized. Incyte also has the option to co-promote products in the United States.

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