UK-based Shire (SHPGY) recently announced that the European Medicines Agency (EMA) has increased the company’s manufacturing flexibility for Replagal (agalsidase alfa), an enzyme replacement therapy approved for treating Fabry disease.
The EMA declared that Replagal can be purified at its new manufacturing facility located in Lexington. The European approval for the new manufacturing facility for Replagal was sought by Shire in April 2011.
The approval grants Shire, the global market leader for the treatment of Fabry disease, an additional manufacturing facility to purify the product. Prior to the approval, Replagal was purified only at the company’s facility in Alewife, Cambridge.
The increased manufacturing strength will enable Shire meet the huge demand for treating the disease in a more efficient manner. Shire’s Replagal competes with Sanofi-Aventis’ (SNY) Fabrazyme in the market for Fabry disease.
Shire intends to use the Lexington facility for manufacturing another product of its Human Genetic Therapies (HGT) franchise namely Vpriv (velaglucerase alfa). Vpriv is approved for treating Gaucher disease. Shire intends to seek approval from the EMA for the purpose by year end. Vpriv’s primary competitor in the Gaucher disease market is Sanofi’s Cerezyme.
The news of the European approval of an additional manufacturing facility for Replagal comes close on the heels of another good news for the HGT franchise at Shire. A couple of days back, Shire announced that an advisory panel of the US Food and Drug Administration (FDA) recommended the US approval of Shire’s Firazyr (icatibant) for treating patients (aged 18 years and above) suffering from acute attacks of hereditary angioedema (HAE). HAE is a rare genetic disease characterized by acute swelling of the hands, feet, face and larynx.
We currently have a long-term Neutral recommendation on Shire. The company carries a Zacks #3 Rank (Hold rating) in the short term.
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