Subsequent Event

6 Months Ended

Jun. 30, 2012

Subsequent Event

Subsequent Event

17.  Subsequent Event

In July 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, issued a negative opinion regarding the Marketing Authorization Application submitted for ISTODAX® (romidepsin) for the treatment of relapsed or refractory PTCL.  We remain convinced of the favorable benefit/risk profile of romidepsin, which has the potential to offer an important new treatment option in this area of high unmet medical need in the European Union, or EU, where no agents are currently approved.  We will therefore, in accordance with European regulations, request a re-examination of the CHMP opinion.

The negative opinion announced by the CHMP is expected to reduce both the fair value of the contingent consideration issued in the acquisition of Gloucester and the gross carrying value of the IPR&D product rights related to ISTODAX® for PTCL in Europe.  We estimate the net impact to our Consolidated Statements of Income for 2012 will be a net benefit of between $10.0 million and $20.0 million.