Shire Announces European Approval of VPRIV® for the Treatment of Type 1 Gaucher Disease

Aug 26, 2010 - Cambridge, MA, US – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that the European Commission has granted marketing authorisation for VPRIV® (velaglucerase alfa), a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of type 1 Gaucher disease. VPRIV has been authorized as an orphan medicine through the Centralised Procedure, making it available in 30 countries across Europe.

This approval was based on data from Shire’s velaglucerase alfa clinical development programme which represents the largest and most comprehensive clinical data set supporting registration for an ERT for type 1 Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints.

This approval was based on data from Shire’s velaglucerase alfa clinical development programme which represents the largest and most comprehensive clinical data set supporting registration for an ERT for type 1 Gaucher disease. In total, over 100 Gaucher patients at 24 sites in 10 countries around the world participated in the clinical studies, all of which met their primary endpoints.

“The Marketing Authorisation for VPRIV in the EU is an important milestone for Shire,” said Sylvie Grégoire, President, Shire Human Genetic Therapies. “Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the US months ahead of schedule.”