DUBLIN and LEXINGTON, Massachusetts, June 24, 2011 /PRNewswire/
—
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.
Notes to editors
SHIRE PLC
Shire’s strategic goal is to become the leadin
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