Canadian Approval for Shire Drug - Analyst Blog

Recently, Shire Plc. (SHPGY) received a boost when Health Canada approved Vpriv (velaglucerase alfa), its drug for Gaucher disease, for pediatric and adult patients. The approval was based on a large clinical program conducted at 24 sites in 10 countries. Over 100 patients participated in the clinical studies. All the clinical studies met their primary endpoints.

The product is already available in the US where it received approval from the US Food and Drug Administration (FDA) in February 2010. Vpriv enjoys orphan drug status in the US. Vpriv was approved in the European Union in August 2010.

Gaucher disease, genetically transmitted, has an incidence of approximately 1 in a population of 50,000. The disorder mainly leads to the enlargement of the spleen and liver among other symptoms and can also prove to be fatal.

Competition for Vpriv

Genzyme's (GENZ) Cerezyme is the lead player in the Gaucher Disease market. We expect competition in the Gaucher disease market to intensify further with the potential approval of Protalix BioTherapeutics Inc.'s (PLX) Uplyso in February 2011. Protalix has a marketing agreement with Pfizer Inc. (PFE) for Uplyso. We note that both Vpriv and Uplyso were made available to patients under the FDA's expanded access program due to the shortage in supply of Cerezyme in 2009. Though Genzyme has resumed supply of Cerezyme, we believe Vpriv/Uplyso could still eat into Cerezyme's market share.

We currently have a Neutral recommendation on Shire, which is supported by a Zacks #3 Rank (short-term Hold rating). We believe Shire needs to expand its pipeline in order to maintain growth beyond 2015, as there are very few projects to be launched thereafter.

 
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