Published on 10/04/12 at 12:23pm
Merck has teamed up with catalyst specialist Codexis to develop a more efficient manufacturing process for recently-approved hepatitis C treatment Victrelis.
Merck was granted approval for NS3/4A protease inhibitor Victrelis (boceprevir) in the US last May and in Europe the following July.
Sales of the product have quickly ramped up to reach nearly $90 million in the fourth quarter of 2011 and $140 million for the full year, despite being available only in a handful of markets.
Analysts have tipped Victrelis as a future blockbuster, and Merck has enlisted the aid of Codexis to make the production process more efficient and boost its profit margin for the drug at a time when the firm is facing patent expiries on some key product lines.
Merck and Codexis scientists developed an enzyme-based production method for a key intermediate in the production of boceprevir that has been recently published in the Journal of the American Chemical Society (JACS).
The JACS publication describes the creation and characterisation of a biocatalyst that was capable of performing a key step in the synthesis of boceprevir.
The new method increased chemical intermediate yield 150% over the previous process, according to the paper. Moreover, it reduced raw material use by 60%, water use by 61% and overall process waste by 63%, making the manufacturing process greener.
"Incorporation of innovative environmentally sustainable means of manufacture is a key aspect of our research and development strategy," commented Richard Tillyer, senior vice president for Discovery and Preclinical Sciences at Merck Research Laboratories.
"Enzymatic based methods can offer a biodegradable and renewable alternative to currently employed methods."
Biocatalysts - generally based on enzymes - have been used on a small scale in the pharmaceutical industry for many years, but it is only in the last few years that they have migrated into the commercial-scale manufacturing environment.
Pressures on the profitability of drugmakers have encouraged the industry to cut costs and boost efficiencies across the board, including in manufacturing, and Codexis has tapped into that trend.
Last year the company reported sales growth of 16% to $124 million that it said was "driven by increased sales to both generic and innovator pharmaceutical customers".
Phil Taylor
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