FDA gives OK to Merck, Codexis for new green manufacturing process

The FDA has given the green light to a green process for making Merck's ($MRK) diabetes drug Januvia that boosts production and cuts byproducts.

The process was developed in collaboration with Codexis ($CDXS). In a scientific paper published by the two companies, they reported that yield increased 10% to 13%, and productivity increased 53% while there was a nearly 20% reduction in total waste, InPharm reports. The process won the two a Presidential Green Chemistry Award in 2010.

"FDA approval of this manufacturing process is a major milestone for Codexis," said Peter Strumph, the firm's interim chief executive.

Codexis claims that the key to the process is a novel enzyme that was systematically customized using Codexis technology to perform the key chemical step in the sitagliptin synthesis process, that is suitable for use at the commercial-scale level. inPharm reports it is only recently that biocatalysts have moved from small-scale to commercial-level production.

The two companies are also trying to juice up the manufacturing process for the recently approved hepatitis C treatment Victrelis and are working on a new method to manufacture Merck's asthma drug Singulair.

While cutting manufacturing costs is a good thing in general, it becomes even more important for drugs like Singulair, as they come off of patent protection and so go head-to-head with generic manufacturers that have squeezed every cent out of manufacturing to make their products as cheap as possible.

- read the InPharm story

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