Shire Wins EU Agency’s Backing for Plant to Ease Drug Shortage
February 23, 2012, 7:31 AM ESTBy Trista Kelley
Feb. 22 (Bloomberg) -- Shire Plc won approval from a European Union regulator for a new factory that would boost output of medicines for rare genetic disorders, potentially hurting sales of rival treatments from Sanofi’s Genzyme unit.
The European Medicines Agency’s Committee for Medicinal Products for Human Use approved the Lexington, Massachusetts, facility for the making of Vpriv to treat Gaucher disease, Dublin-based Shire said today in a statement. The decision must be ratified by the European Commission, and that’s expected imminently, the company said.
Shire gained sales and market share after manufacturing glitches at Genzyme in 2009 resulted in a shortage of the treatments Fabrazyme for Fabry disease and Cerezyme for Gaucher. As patients struggled with limited dosing schedules, the U.S. Food and Drug Administration allowed Shire to give its medicines, Replagal and Vpriv, away for free in the U.S. even though the drugs weren’t approved there.
The agency cleared Vpriv for sale in February 2010 and Shire expects an FDA decision on Replagal in May. Sales of all four drugs brought in about $1.5 billion for Sanofi and Shire last year.
Shire plans to shift manufacturing of Vpriv to the new facility, freeing up an existing plant to make more Replagal. Shire will ramp up production and be able to meet global demand for both of the drugs by the end of the year, Chief Executive Officer Angus Russell said on a Feb. 9 conference call.
--Editors: Phil Serafino, David Risser
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To contact the reporter on this story: Trista Kelley in London at tkelley2@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net -0- Feb/10/2012 16:37 GMT
