Foreign company's U.S. plant produces drugs for foreign consumers

The trade balance calculation might take some doing, but United Kingdom-based Shire is building new manufacturing facilities in the United States and some of the first drugs to spill from one of the new facilities will go back to Europe.

Shire's new manufacturing facility in Lexington, Mass., will help the pharmaceutical company to the produce the drug Vpriv (velaglucerase alfa), which helps treat Gaucher disease and which was just approved by the European Medicines Agency's Committee for Medical Products for Human Use. The European Commission probably will approve shortly.

Gaucher disease is a rare, chronic, progressive, inherited genetic disorder involving the lack sufficient levels of a particular enzyme. A fatty material, or lipid, accumulates in the body. The accumulation in organs and bones can cause pain throughout life.

Shire is based in Basingstoke, about halfway between London and Southampton in the United Kingdom, but its U.S. headquarters is in Wayne.

Shire's drug Replagal is used to treat Fabry disease, which is also a rare disorder that also involves problems of digestion within the cells in the body. The symptoms can include wart-like skin discoloration, pain in the fingers and toes and belly aches. Problems of kidney failure, heart disease and stroke can be part of the problem later in life.

With the new plant approved by European authorities, Shire can make Replagal at a slightly older plant in Alewife, Mass. Replagal is approved for use in 46 countries, but not in the United States.

"I am delighted to announce the EMA approval of our facility," Bill Ciambrone, Shire's senior vice president, technical operations, said in a statement released by the company. "Shire has invested strategically in new manufacturing facilities and state-of-the-art technology because we recognize the critical importance of ensuring the continuity of treatment for patients with rare and life-threatening diseases."