Bristol-Myers Squibb still on top over Keytruda

Keytruda patent settlement places Bristol-Myers Squibb in an unbeatable position despite recent setback, says GlobalData

Bristol-Myers Squibb and Merck have settled a year-long patent fight over Keytruda, according to an analyst with research and consulting firm GlobalData.

Keytruda (pembrolizumab) is a drug which is quickly becoming available for a number of cancer indications including non-small cell lung cancer (NSCLC).

The dispute arose after BMS claimed that Merck had infringed BMS and Ono’s patent related to the use of program cell death 1 (PD-1) antibodies to treat cancer in the US, Europe, Australia, and Japan.

As part of the settlement, Merck agreed to pay BMS and Ono an initial sum of $625m, plus royalties of 6.5% of Keytruda’s global sales from 2017 to 2023 and 2.5% from 2024 through 2026.

“BMS can now sit back and enjoy the stream of royalty revenue coming from Keytruda while Merck pays the bills for the drug’s aggressive clinical development program.”

Fenix Leung, DPhil, Pharmaceutical Consultant for GlobalData, explains:

“BMS and Ono’s Opdivo has been in close competition with Keytruda to become the first available PD-1 drug in various cancer indications. Opdivo had a clear win against Keytruda in 2015 and the first half of 2016. However, it has seen major setbacks recently as it flopped in a first-line trial for NSCLC.”

BMS had just given up the accelerated approval pathway for the Opdivo and Yervoy combination in NSCLC.

“By contrast, Keytruda has been speedily expanding into the first-line setting in NSCLC,” said Leung.

“Nevertheless, BMS can now sit back and enjoy the stream of royalty revenue coming from Keytruda while Merck pays the bills for the drug’s aggressive clinical development program.”

GlobalData expects more patent litigations to take place, as more PD-1-targeting drugs are expected to launch in the next couple of years. So far, Roche’s Tecentriq (atezolizumab) has not received any complaints, probably because it is hitting another target in the pathway, the program death ligand 1 (PD-L1).

However, as more PD-1/PD-L1 drugs appear on the market, GlobalData predicts that big companies will increasingly engage their competitors in costly legal battles.

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