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UPDATE 1-Sanofi starts shipping Fabrazyme from new plant
March 1, 2012 / 2:31 PM / 6 years ago

UPDATE 1-Sanofi starts shipping Fabrazyme from new plant

PARIS, March 1 (Reuters) - French drugmaker Sanofi said on Thursday its Genzyme unit has begun delivering rare disease drug Fabrazyme from its newly approved plant in Framingham, Massachusetts, after being forced to ration the drug due to production problems.

Patients in the U.S. will be able to either return or begin treatment at full dosing levels this month, although in Europe the full dose will initially be available to the most severely affected patients.

The full return to normal supply levels of Fabrazyme will begin in the second quarter and will continue throughout 2012, Sanofi said.

Supplies of the drug had to be rationed in 2009, when contamination problems forced Genzyme to temporarily close its plant in Allston, Massachusetts, which also led to shortages of another rare-disease drug, Cerezyme.

While Genzyme was able to resume normal deliveries of Cerezyme in late 2010, production of Fabrazyme had to be constrained until the regulatory approval of the new Framingham plant.

The Food and Drug Administration and the European Medicines Agency approved the plant for the production of Fabrazyme in January 2012.

The drug treats Fabry disease, a rare inherited condition that is characterized by excessive fat accumulation in various organs and tissues.

Genzyme’s production problems have benefited U.K. drug company Shire, the maker of rival Fabry disease therapy Replagal and Vpriv, which competes with Cerezyme for the treatment of Gaucher disease.

Sanofi shares were trading up 2 percent at 56.60 euros at 1418 GMT, outperforming the CAC40 index, up 1 percent. (Reporting by Elena Berton)

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