STATEMENT RELATING TO SHIRE’S VPRIV® (VELAGLUCERASE ALFA FOR INJECTION) PRESS RELEASE DATED JUNE 28, 2012

February 25, 2014

On June 28, 2012, Shire issued a press release relating to VPRIV® (velaglucerase alfa for injection), its enzyme replacement therapy for Type 1 Gaucher disease.  The press release reported on the presentation of exploratory data at a scientific conference held in Paris on that date.  The data were derived from a 9-month, Phase III, multi-center, randomized non-inferiority study and its 15-month extension study, and showed VPRIV’s effect on selected markers of Gaucher-related bone disease against baseline.  The press release also included data on Genzyme Corporation’s enzyme replacement therapy for Type 1 Gaucher disease, Cerezyme® (imiglucerase for injection).

Shire wishes to state:

  • The studies from which the data were derived were not designed to compare the effectiveness of VPRIV and Cerezyme in improving bone mineral density; therefore the press release should not be construed to suggest any such comparison, including any claim of superiority of VPRIV over Cerezyme.
  • The changes in bone mineral density were examined as an exploratory endpoint in the studies.  Accordingly, the data described in the press release should not be construed as proof of efficacy with respect to bone mineral density.  Further well-designed studies would be required before conclusions about efficacy with respect to bone mineral density could be drawn.

VPRIV Important Safety Information
The most serious adverse reactions seen with VPRIV were hypersensitivity reactions. Infusion-related reactions were the most commonly observed adverse reactions in patients treated with VPRIV in clinical studies. The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, low or high blood pressure, nausea, tiredness and weakness, and fever.  Generally the infusion-related reactions were mild and, in treatment-naïve patients, onset occurred mostly during the first 6 months of treatment and tended to occur less frequently with time.

All adult side effects of VPRIV are considered relevant to children (ages 4 to 17 years). Side effects more commonly seen in children compared with adult patients included: upper respiratory tract infection, rash, aPTT prolonged, and fever. The safety of VPRIV has not been established in patients younger than 4 years of age.

VPRIV is not available in all countries and prescribing information may differ between countries.  Please consult your local prescribing information. Full prescribing information for VPRIV in the U.S. can be found at www.VPRIV.com.

 

For further information please contact:

Investor Relations
Eric Rojas
erojas@shire.com
+1 781 482 0999

Sarah Elton-Farr
seltonfarr@shire.com
+44 1256 894157

Media 

Jessica Mann
jmann@shire.com
+44 1256 894 280

Gwen Fisher
gfisher@shire.com
+1 484 595 9836