Benzinga | Oct 18, 2021 08:07AM EDT

Codexis, Almelo And RC2 Announce A Tri-Party Collaboration For The Enzymatic Production Of Low Cost Sitagliptin API For The Generic Market, Including A License To Codexis Enzyme Technology In India

Codexis, Inc. (NASDAQ:CDXS), a leading enzyme engineering company enabling the promise of synthetic biology, announced a tri-party collaboration agreement with Almelo Private, Ltd., an Indian producer of active pharmaceutical ingredients (APIs), and RC2 Pharma Connect, LLC, a U.S.-based leading pharmaceutical manufacturing representative, to license and manufacture for internal use a Codexis' proprietary enzyme used in the manufacturing process for sitagliptin, a leading API in the treatment of diabetes. Under the agreement, Almelo will be responsible for the development, scale-up, and establishment of a commercial manufacturing process for sitagliptin incorporating Codexis' proprietary enzyme technology. Upon completion, the enzyme's manufacturing will be established at Almelo's API manufacturing site to enable further cost reduction. RC2's role in the collaboration will be to leverage its relationships with global drug product partners to establish downstream supply channels for the future generic sitagliptin market.

"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," said John Nicols, President and CEO of Codexis. He added, "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. "

Anand Tatambhotla, Almelo's Executive Director, Operations 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."

Dwight Raff, President and CEO of RC2 added, "We are delighted to have brokered this deal among three companies with very different capabilities and areas of expertise, in what we believe will be very much a 'more than the sum-of-the-parts' collaboration. We look forward to working closely with Codexis and Almelo to drive market penetration through our relationships in the drug product arena and to generate significant value for the partnership and for customers and patients."