Development of Biocatalytic Process to Manufacture Simvastatin
Recognized by EPA
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Jun. 18, 2012--
Codexis, Inc. (Nasdaq:CDXS) today 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.
“Collaborating with the Codexis team was a true inspiration. Their
directed evolution technology empowered us to go beyond academic theory
and deliver a more environmentally friendly process that is impacting
the pharmaceutical industry today,” said Yi Tang, Professor, University
of California Los Angeles.
“Green chemistry and Codexis’ CodeEvolver™ directed evolution technology
represent the future of cleaner, more efficient, and cost-advantaged
pharmaceutical manufacturing processes. With the help of Professor Tang
and his team, this award confirms Codexis’ role as an industry leader,
and we are honored to be recognized for a third time by the EPA for our
achievements,” said Gjalt Huisman, Ph.D., Vice President of Product
Planning, Pharmaceuticals at Codexis.
The process was scaled up at Codexis’ longstanding collaborator, Arch
Pharmalabs Ltd., 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 Ltd.
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.
About Presidential Green Chemistry Challenge Awards Program
The Presidential Green Chemistry Challenge Awards are presented annually
by the Environmental Protection Agency to recognize new technologies
that help prevent pollution by reducing or eliminating hazardous waste
in industrial production. It provides recognition of outstanding
chemical technologies that incorporate the principles of green chemistry
into chemical design, manufacture, and use, and that have been or can be
utilized by industry in achieving their pollution prevention goals. The
award was launched in 1995 in partnership with the chemical industry,
the American Chemical Society, the National Academies and other
About Codexis, Inc.
Codexis, Inc. is a developer of cost-advantaged processes for the
production of biofuels, bio-based 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,
Source: Codexis, Inc.
Kelly McAlearney, 415-503-4073 (Media)