Shire's clinical study results for treatment of Gaucher disease to be presented at LDN World Symposium

Feb 4 2010

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida. In addition to two oral presentations and two poster presentations on Gaucher disease, the company will present findings from a re-analysis of disease stage progression in Globoid Cell Leukodystrophy (GLD). Dr. Michael West from Dalhousie University in Halifax, Canada will also present head-to-head REPLAGAL ® 0.2 mg/kg and Fabrazyme 1.0 mg data, sponsored by the Canadian Fabry Disease Initiative (CFDI).  

"We are excited to participate in this very important scientific meeting," said Whaijen Soo, MD, PhD, Senior Vice President, Research and Development, Shire Human Genetic Therapies (HGT). "Shire continues to deliver on its promise to pursue the development and commercialization of treatments which will enable people with life-altering conditions to lead better lives – and we're looking forward to sharing data which underscores the success of our commitment in the area of rare genetic diseases."    

A summary of the key scientific presentations is provided below. Information about these data presentations mentioned in this release is embargoed until the respective presentation sessions have taken place at the meeting.

Gaucher disease

• February 10, 2010; 4-6 PM EST - Enzyme Replacement Therapy with velaglucerase alfa Improves Key Clinical Parameters in a Pediatric Subgroup with Type 1 Gaucher Disease
• February 10, 2010; 4-6 PM EST - Five-Year Safety and Efficacy of velaglucerase alfa in Gaucher Disease Type 1: Experience in Clinic and Home Settings
• February 11, 2010; 9:30 AM EST - Enzyme Replacement Therapy with velaglucerase alfa Significantly Improves Key Clinical Parameters in Type 1 Gaucher disease: Positive Results from a Randomized, Double-blind, Global Phase III Study (Oral Presentation)
• February 11, 2010; 9:45 AM EST - Antigenic Differences in Patients Receiving Velaglucerase alfa or Imiglucerase (Oral Presentation)

Globoid Cell Leukodystrophy

• February 11, 2010; 3:30 PM EST - A Re-analysis of Disease Stage Progression in Krabbe Disease (infantile Globoid Cell Leukodystrophy, iGLD) (Oral Presentation)

Fabry disease

• February 11, 2010; 11:00 AM EST - A Randomized Controlled Trial of Enzyme Replacement Therapy in Fabry Disease: The Canadian Fabry Disease Initiative at Year Three (Oral Presentation)