Codexis and Merck Renew Supply Agreement for Sitagliptin Enzyme

Codexis and Merck renew supply agreement for the enzyme used in the Sitagliptin manufacturing process.

FREMONT, CA: Codexis, Inc., a leader in enzyme engineering that enables the promise of synthetic biology, has extended its agreement with Merck, known as MSD outside the United States and Canada, to license and supply a proprietary enzyme used in the manufacturing process for sitagliptin, the active pharmaceutical ingredient (API) in Merck's JANUVIA® and one of the atypical antipsychotic medications.

“Codexis relationship with Merck spans more than a decade, including R&D collaboration, a CodeEvolver® license, and commercial product supply, and we are proud to extend our partnership even further for the supply of this proprietary, high-performance enzyme for the API in JANUVIA®,” says John Nicols, President, and CEO of Codexis. “Our CodeEvolver® enzyme engineering platform enables Codexis and our partners to design unique enzymes with performance improvements that dramatically reduce the cost and improve the efficiency and sustainability of their API manufacturing.”

Codexis and Merck have collaborated on a research and development agreement to develop a novel, proprietary enzyme to act as a biocatalyst in the sitagliptin manufacturing process. The resulting enzyme simplified the manufacturing process and enhanced output while lowering costs and waste. In 2010, the US Environmental Protection Agency (EPA) awarded Codexis and Merck the annual Presidential Green Chemistry Challenge Award for developing this unique biocatalytic technique for sitagliptin production. Codexis and Merck inked a supply deal for the enzyme in 2012 and a multi-year extension in 2015, both of which were set to expire in February 2022. The following extension and amendment cover the licensing and delivery of the proprietary enzyme through December 31, 2026. The extension may be renewed for a further five years if both firms agree.