Subsequent Events

3 Months Ended

Mar. 31, 2017

Subsequent Events

Subsequent Events

16.    Subsequent Events

In connection with its acquisition of ARIAD that closed in February 2017, Takeda Pharmaceutical Company Limited notified us that they do not intend to exercise the Buy-Back Provision (described in Note 3) under the terms of the ARIAD License Agreement, and the Buy-Back Provision has now lapsed.

In April 2017, we and Lilly announced that the FDA had issued a complete response letter for the New Drug Application of baricitinib as a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis. The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the FDA’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.