Merck plant gets FDA nod for bulk varicella

A $1 billion overhaul of Merck & Co.'s ($MRK) vaccine manufacturing operations continues to pay dividends for the drugmaker. The FDA has approved its Durham, NC, site to manufacture bulk varicella for its chickenpox and shingles vaccines.

Already approved in 2010 to produce finished chickenpox vaccines, the company said the long-term goal is for the facility to produce bulk and finished products for other Merck childhood vaccines, as well as the shingles vaccines. The company, known as MSD outside of North America, has been producing all of its bulk supplies for Merck's varicella-containing vaccines at a plant in West Point, PA.

Nearly a decade ago, Merck began an extensive overhaul of its vaccine manufacturing that has included its operations in West Point and Elkton, VA, as well as Durham, where 1,100 people now work. It also built a $295 million vaccine-production plant in Carlow, Ireland, which it expects to be licensed in 2014. That plant is slated to have 170 jobs.

Merck kicked off the overhaul when supply issues for its shingles vaccine Zostavax put a damper on its launch. The company resolved to get on top of the problems and used a fast-track program to build a 214,000-square-foot facility that doubled the output of Zostavax and Varivax, its chickenpox vaccine. With production ramping up at the refurbished manufacturing plant, the company last year invested $15 million to overhaul a nearby packaging plant in Wilson, NC, to accommodate that output.

Merck said yesterday that the FDA approval will allow it to not only make bulk product for the U.S. market but also expand supplies globally. "The licensure of the Durham varicella bulk facility marks a significant milestone for Merck and adds additional manufacturing capabilities to an already strong Merck vaccine network," said Willie Deese, president, Merck Manufacturing Division.

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