Eli Lilly and Company and Incyte Corporation announced that Lilly has submitted a new drug application (NDA) to the U.S. 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 U.S. 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.
This submission milestone will result in a first-quarter charge to Lilly's GAAP and non-GAAP research and development expense of $35 million (pre-tax). Lilly's previously-issued 2016 GAAP and non-GAAP EPS guidance of $2.92-$3.02 and $3.45-$3.55, respectively, remain unchanged.
"Lilly's collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA," said David Ricks, president of Lilly Bio-Medicines.
