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Shire Announces European Approval Of Manufacturing Facility For VPRIV® (velaglucerase Alfa)

Stocks in this article: SHP SHPGY

Shire has invested over $200M in manufacturing infrastructure and technology to ensure that we maintain a reliable and consistent drug supply. In keeping with Shire's corporate sustainability commitments, this new manufacturing plant has met the requirements for Leadership in Energy and Environmental Design (LEED) Certification and will receive formal recognition from the United States Green Building Council this quarter. In addition to increasing capacity and reducing manufacturing risk, utilization of single-use technology requires approximately 80% less water and 50% less energy than a conventional manufacturing plant.

About  VPRIV  (velaglucerase alfa)

VPRIV is made using Shire's gene activation technology, in a human cell line. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme.

VPRIV is used for the long-term treatment of patients with type 1 Gaucher disease.

VPRIV is approved in 38 countries globally, including the US, the European Union, and Israel and is for patients who are treatment-naïve as well as patients who have previously been treated with imiglucerase.

About REPLAGAL (agalsidase alfa)

REPLAGAL is a human form of enzyme alpha-galactosidase A (α-Gal A) manufactured in a human cell line by gene activation. 2011 marked the 15th year of clinical experience with REPLAGAL, which is now approved in 46 countries worldwide. REPLAGAL is not currently approved for commercial sale in the U.S.

REPLAGAL is the only human-cell-line-derived form of enzyme replacement therapy that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease (α-Gal A deficiency).

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.

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