Codexis Inc. (NASDAQ: CDXS) has entered a tri-party partnership agreement with Indian active pharmaceutical ingredients (APIs) producer Almelo Private Ltd. and US-based pharmaceutical manufacturing representative RC2 Pharma Connect LLC.
Partnership to license and produce sitagliptin
The collaboration is for the licensing and manufacture of Codexis’ novel enzyme used in sitagliptin manufacturing process. Sitaglipyin is a top API in diabetes treatment. Almelo will be in charge of developing, scaling up, and establishing a commercial production process for sitagliptin using Codexis’ patented enzyme technology under the terms of the agreement. The enzyme’s manufacturing will be established at Almelo’s API manufacturing plant once it’s finished. The collaboration’s purpose for RC2 will be to use its ties with global drug product partners to build downstream supply channels for the eventual generic sitagliptin market.
Codexis CEO John Nicols said, “We are delighted Almelo has embraced the opportunity to leverage Codexis’ highly optimized enzyme to reduce the cost and improve the efficiency and sustainability of their sitagliptin API manufacturing. Almelo is a forward looking and innovation-focused company, and we are very pleased that they have committed to install the capability to self-produce the enzyme, allowing them to drive as much cost as possible from their process. Adding the expertise of RC2 enables an integrated low cost supply chain to uniquely position the partnership for success in the coming competitive generic sitagliptin marketplace.”
Sitagliptin is a strategic product for Almelo
Almelo Executive Director Operations Anand Tatambhotla said, “Codexis is the leading enzyme developer in the pharmaceutical manufacturing space and we are excited to have secured access to their proprietary biocatalyst for production of this important API, including the ability for us to drive to the lowest possible cost position through self-manufacture of the enzyme. Sitagliptin is an important strategic product for Almelo and with this collaboration, alongside our proven capabilities in process innovation and efficiency optimization, we are positioned for long term success, following the innovator’s loss of exclusivity.”