REDWOOD CITY, Calif.--(BUSINESS WIRE)--Codexis, Inc. (Nasdaq:CDXS), a developer of industrial enzymes to enable the cost advantaged production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that the FDA has approved a new process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia®.
“FDA approval of this manufacturing process is a major milestone for Codexis,” said Peter Strumph, Interim Chief Executive Officer. “This is another example of how our directed evolution technology can deliver well controlled, cost advantaged commercial pharmaceutical, biofuel, or bio-based chemical production processes.”
The approved process, which won the Presidential Green Chemistry Award in 2010, is a more environmentally friendly and efficient production process than those used in the past. Specifically, it indicates the potential for improving the overall increase in yield of sitagliptin, while significantly decreasing waste byproducts.
About Codexis, Inc.
Codexis, Inc. is a developer of industrial enzymes to enable the production of biofuels, biobased chemicals and pharmaceutical intermediates. Codexis’ product lines include CodeXyme™ Cellulase Enzymes and CodeXol™ Detergent Alcohol. Partners and customers include global leaders such as Shell, Merck and Pfizer. For more information, see www.codexis.com.
Forward-Looking Statements
This press release contains forward-looking statements relating to Merck’s potential use of a manufacturing process for sitagliptin that was co-developed by Codexis. Important factors that could cause actual results to differ materially from the forward-looking statements in this press release include risks that Merck may not use this new process and that sitagliptin may lose market share. Additional factors that could materially affect actual results can be found in Codexis’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2012, including under the caption “Risk Factors.” Codexis expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.