Codexis on Monday announced it has been awarded the annual Presidential Green Chemistry Challenge Award from the U.S. Environmental Protection Agency (EPA) for the development of an efficient biocatalytic process to manufacture simvastatin, a leading drug for treating high cholesterol. This marks the third time in seven years that Codexis has been honored with this award; Codexis was a recipient in 2006 and 2010.

Simvastatin is the most prescribed statin in the U.S., with 94.1 million prescriptions in 2010 according to IMS Health. Traditionally, synthesis of simvastatin has required an inefficient, multistep chemical process that involves significant quantities of hazardous reagents. In collaboration with Professor Yi Tang at the University of California, Los Angeles, Codexis conceived and developed a synthesis using an engineered enzyme and a practical, low-cost feedstock.

Codexis optimized both the enzyme and the chemical process for the large-scale, commercial manufacture of simvastatin. The resulting process produces high quality simvastatin in a cost-effective manner and greatly reduces the use of hazardous chemicals and the amount of waste produced.

The process was scaled up at Codexis' longstanding collaborator, Arch Pharmalabs, in Mumbai, India. Arch Pharmalabs manufactures a number of products for Codexis, including the 2006 Presidential Green Chemistry Challenge Award-winning process for atorvastatin, the active ingredient in Pfizer's Lipitor.

"We are running six biocatalytic processes developed by Codexis and have shown that they are reliably scalable and comparable to chemical processes, while offering significant advantages in terms of product purity, reduced waste, and reduced energy consumption," said Dr. Ganesh Pai, Director of Research and Development, Arch Pharmalabs.

Codexis is the first and, to date, only company to have won the Presidential Green Chemistry Challenge Award in both the small business and open categories. In 2010, in collaboration with Merck, Codexis won a previous Green Chemistry award for the development of a novel biocatalytic method for the synthesis of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia. And in 2006, as a small business with less than $40 million in annual sales, Codexis was similarly honored for developing three enzymes used to produce the key chiral building block for atorvostatin.