Sitagliptin supply deal signed

Following on from the extension of a long-standing supply agreement with Merck & Co. for a proprietary enzyme used in the manufacture of sitagliptin, Codexis has reached a manufacturing agreement with two other firms. Sitagliptin is the API in Merck’s Januvia and one of the APIs in Janumet.

Under the tri-party collaboration agreement, Indian API producer Almelo will develop a manufacturing process for sitagliptin incorporating the enzyme and carry out the manufacture. RC2 Pharma Connect, a US-based manufacturing representative, will seek to establish downstream drug product manufacture for the future generic sitagliptin market.

Codexis’ supply relationship with Merck dates back to 2012 and was renewed again in 2015 before being renewed again in September until the end of 20126. It could then be renewed for a further five years by mutual consent.

As well as an R&D collaboration, the deal included a licence to the CodeEvolver enzyme engineering technology, which was used to design a novel enzyme to serve as a biocatalyst in the sitagliptin manufacturing process. This won the US EPA’s Presidential Green Chemistry Challenge award in 2010.