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.