Merck & Co will have to pay Bristol-Myers Squibb and Ono Pharmaceutical an initial $625 million as part settlement of patent litigation against Merck’s programmed cell death protein-1 (PD-1) anticancer antibody Keytruda® (pembrolizumab). Bristol-Myers Squibb and Ono claimed that Keytruda sales infringed on their own PD-1 antibody patents, which underpin Bristol-Myers Squibb’s antibody therapeutic Opdivo® (nivolumab).

The settlement, reported late Friday, also requires Merck to pay 6.5% royalties on global sales of Keytruda through to the end of 2023, and then 2.5% royalties until the end of 2026. The royalties will be split 75/25 between Bristol-Myers Squibb and Ono, respectively. The agreement allows for the companies to give each other specific rights under their respective PD-1 patent portfolios. 

Commenting on the settlement, Bristol-Myers Squibb CEO, Giovanni Caforio, M.D., said, “Bristol-Myers Squibb and Ono’s agreement with Merck protects our scientific discoveries and validates the strong intellectual property rights we secured as the early innovators in the science of PD-1, a key mechanism in immuno-oncology that has proven to have transformational impact in cancer care. Today’s agreement is also a good decision for patients as it supports the continuation of ongoing research and maintains access to anti-PD-1 therapies for cancer patients around the world.”

Announcement of the settlement comes just days after Bristol-Myers Squibb confirmed that it would not chase accelerated FDA approval of its Opdivo plus Yervoy® (ipilimumab) combination therapy for the major indication of first-line lung cancer therapy. Earlier this month, competitor Merck’s Keytruda plus carboplatin combination therapy was granted priority review by FDA for the first-line treatment of metastatic or advanced nonsquamous non-small-cell lung cancer (NSCLC), in patients with no anaplastic lymphoma kinase (ALK) or epidermal growth factor receptor (EGFR) mutations, and irrespective of programmed cell death protein ligand-1 (PD-L1) expression. The target action date is May 10 2017.

Earlier this month Merck and Incyte confirmed that they would expand the Phase III clinical development program for Keytruda in combination with Incyte's investigational oral selective indoleamine-pyrrole 2,3-dioxygenase (IDO1) inhibitor epacadostat to encompass four additional tumor types, including NSCLC. Within the last few weeks, Keytruda has also been approved in Japan for the first-and second-line treatment of patients with PD-L1-positive unresectable advanced/recurrent NSCLC, and has been recommended by the European Medicines Agency’s CHMP for approval as first-line therapy of metastatic NSCLC in tumors with high PD-L1 expression. A final decision is expected by the European Commission during Q1 2017. Keytruda was approved by FDA for the first-line treatment of NSCLC tumors with high PD-L1 expression in October 2016.

Bristol-Myers Squibb has pushed on with development of Opdivo in combination with other drugs for the lung cancer indication since August 2016, when a pivotal Phase III monotherapy study in treatment naïve NSCLC patients failed to meet its primary endpoint. Earlier this month Bristol-Myers Squibb said it was teaming up with Janssen Biotech to carry out Phase Ib/II studies with Opdivo in combination with the latter’s CD38-targeting antibody Darzalex®, against multiple myeloma and solid tumor types, including NSCLC. This agreement builds on the firms’ clinical research collaboration to evaluate Opdivo and Janssen’s live attenuated double-deleted (LADD) Listeria monocytogenes cancer immunotherapy against NSCLC.


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