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U.S. Patent Awarded for Synthetic Hepatitis C Biocatalysts

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The U.S. Patent and Trademark Office awarded yesterday a patent covering biocatalysts and biocatalytic processes used to make intermediate products in the synthesis of hepatitis C drugs. Patent number 8,178,333 was awarded to 13 inventors and assigned to Codexis Inc. in Redwood City, California.

Codexis is a biotechnology company that develops and markets engineered enzymes and intermediate products for the pharmaceutical industry. These tailored enzymes, says Codexis, enable pharma companies to streamline their manufacturing processes, saving them money, and improving profitability.

The new patent covers the company’s catalytic enzymes used to produce protease inhibitors such as boceprevir, marketed as Victrelis by Merck & Co. to treat hepatitis C. In addition, the patent applies to the processes to manufacture those synthetic enzymes. The patent remains in force until 2029.

Researchers from Codexis and Merck published an article that appeared last month in the Journal of the American Chemical Society (paid subscription required), describing an enzyme-based production process for boceprevir. The article says the process was developed while the drug was undergoing clinical trials.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis C have no symptoms of the disease until liver damage occurs, which may take several years. The Centers for Disease Control and Prevention estimates between 2.7 and 3.9 Americans are living with hepatitis C, which causes some 12,000 deaths per year.

The Food and Drug Administration approved boceprevir earlier this week, as a treatment for chronic hepatitis C, with patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. The drug’s approval applies when used in combination with peginterferon alfa and ribavirin.

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