Shire gets FDA nod for a second U.S. plant to make Vpriv

Shire ($SHPG) has garnered FDA approval to make its orphan drug Vpriv at a plant in Lexington, MA. That means it now has approval at two plants in the U.S. to manufacture the treatment for type 1 Gaucher disease.

"Shire has always been committed to providing uninterrupted treatment for all Vpriv patients at the dose and frequency prescribed by their physicians. We continue to deliver on this commitment," Bill Ciambrone, executive vice president of technical operations at Shire said in a statement.

That was a shot at Sanofi's ($SNY) Genzyme, which ran into supply problems with its Gaucher disease drug Cerezyme for several years when viral contamination forced the closure of a facility in 2009. It got past those problems with upgrades and by building a new plant to do some of the production, but the problem created real issues for patients with the condition. Until Shire's Vpriv was approved in 2010, Genzyme's Cerezyme was the only FDA-approved treatment for Gaucher disease.

Shire says it has spent more than $200 million on manufacturing infrastructure and technology to make the product. Shire also has a plant in Alewife, MA, that is approved to make it. The Lexington plant was approved by the European Medicines Agency in 2012 to make Vpriv, and Shire said the Leed-certified plant uses about 80% less water and 50% less energy than a conventional manufacturing facility. It is also equipped with single-use bioreactor and disposable technology.

- here's the announcement