Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, MA, US. REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.
With this approval, the company now has two approved facilities - Alewife, which is located in Cambridge, MA, as well as the new Lexington facility - in which to purify REPLAGAL, thus providing increased manufacturing flexibility. The cell culture portion of the REPLAGAL manufacturing process will continue to be conducted at Alewife.
"We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility in order to provide rapid access to important therapies for patients in need," said Bill Ciambrone, Senior Vice President of Technical Operations, Shire HGT. "This new facility allows greater flexibility to meet global demand for our products, including REPLAGAL."
Shire reiterated that it has sufficient product inventory to continue to meet the needs of Fabry patients worldwide currently receiving REPLAGAL and that it can meet anticipated additional demand. The Company is committed to continuing to provide uninterrupted long-term access to the product at the licensed dose.
In addition to REPLAGAL, Shire anticipates regulatory agency submission of the VPRIV (velaglucerase alfa) manufacturing process at the new Lexington manufacturing facility by the end of 2011.