Eli Lilly and Company and Incyte Corporation report that Lilly has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

As a result, Incyte will receive a milestone payment of $35 million from Lilly related to the NDA submission. If baricitinib is granted US regulatory approval, Incyte will receive a milestone payment of $100 million from Lilly. Incyte could earn additional global regulatory as well as sales-based milestone payments and be eligible for royalties on global net sales of baricitinib.

If approved, Lilly will lead launch and global commercialization efforts for baricitinib in RA. Lilly owns global rights to develop and commercialize baricitinib as an oral treatment for all inflammatory conditions.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib is currently in Phase III clinical development for rheumatoid arthritis and Phase II development for psoriasis, diabetic nephropathy, atopic dermatitis, and systemic lupus erythematosus.

Baricitinib is an once-daily oral selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK 3 in kinase assays.

Source: Eli Lilly