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Shire's VPRIV® (velaglucerase Alfa For Injection) Shows Significant Improvement In Gaucher-Related Bone Disease

NYON, Switzerland, June 28, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today presented new data that show VPRIV ® (velaglucerase alfa for injection), the company's enzyme replacement therapy for type 1 Gaucher disease, significantly improved selected markers of Gaucher-related bone disease in patients. These data were presented at the European Working Group on Gaucher Disease (EWGGD) meeting held in Paris, France, from June 28 - 30, 2012.

The data presented demonstrate that VPRIV improves Gaucher-related bone disease by a sustained increase in bone mineral density (BMD). BMD refers to the measurement of mineral matter per square centimeter of bone measured by Z-scores. Z-scores allow for a comparison of a patient's BMD to age- and sex-matched normalized scores in populations without Gaucher disease. In Gaucher disease patients, BMD is generally reduced compared to individuals without Gaucher disease, often resulting in lower Z-scores. Measuring BMD can help to quantify the impact of Gaucher disease on the patient's bone and can help identify the potential benefits of treatment in improving Gaucher-related bone disease.

"Many type 1 Gaucher disease patients experience bone abnormalities," said Professor Ari Zimran, Shaare Zedek Medical Center, Hebrew University and Hadassah Medical School, Jerusalem, Israel. "These study results show that VPRIV is effective in treating selected markers of Gaucher-related bone disease, allowing these patients to achieve an important therapeutic goal quickly."

Results from a head-to-head Phase III study (HGT-GCB-039) of VPRIV and Cerezyme, and follow-on extension trial (HGT-GCB-044) of VPRIV, demonstrate a statistically significant improvement in lumbar spine (LS) BMD in Gaucher patients starting at nine months of treatment with VPRIV (P<0.05). Patients participating in the study were administered 60 U/kg every other week of either VPRIV or Cerezyme for nine months as part of the HGT-GCB-039 study. All patients, including those who received Cerezyme, subsequently received 60 U/kg every other week of VPRIV for an additional 15 months in the extension trial (HGT-GCB-044).

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