Merck announces settlement and license agreement resolving KEYTRUDA

Merck has agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Company and Ono Pharmaceutical, resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as KEYTRUDA (pembrolizumab).

Under the settlement and license agreement, the company will make a one-time payment of $625 million to Bristol-Myers Squibb and provide royalties on the worldwide sales of KEYTRUDA for a non-exclusive license to market KEYTRUDA in any market in which it is approved. The parties also agreed to dismiss all claims in the relevant legal proceedings.

"Today’s announcement eliminates uncertainty and enables us to continue to focus on KEYTRUDA, our immuno-oncology medicine, which is already helping thousands of patients around the world and becoming a foundation for the treatment of cancer through our industry-leading clinical development program," said Kenneth C Frazier, Chairman and CEO, Merck.

The $625 million payment will be recorded in the company’s fourth-quarter and full-year 2016 results. This expense will be excluded from Merck’s non-GAAP results.