Shire Drug Seeks EU Nod - Analyst Blog

Shire plc (SHPGY) continues to make progress with its Gaucher disease candidate, velaglucerase alfa. The company recently submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for velaglucerase alfa for the treatment of type I Gaucher disease. The company has already asked for approval in other markets like the U.S. and Canada.
 
Shire is seeking an accelerated review of the MAA. Given the shortage in supply of Genzyme’s (GENZ) Cerezyme, which is the leader in the treatment of patients with Gaucher disease, the Committee for Medicinal Products for Human Use (CHMP) has accepted Shire’s request.
 
Accordingly, the review time has been reduced by 60 days to 150 days with the review scheduled to commence in December. Once approved and launched commercially, velaglucerase alfa will compete directly with Cerezyme. Shire is currently providing the treatment free of cost to patients. As a reminder, Genzyme is facing problems with the supply of Cerezyme due to the temporary shutdown of its Allston manufacturing plant. While manufacturing has resumed, Genzyme will be in a position to supply new lots of Cerezyme from late November.
 
In order to make up for the shortage in supply of Cerezyme, the U.S. Food and Drug Administration (FDA) had approached Shire and another company, Protalix Biotherapeutics Ltd. (PLX), to come up with treatment protocols for their Gaucher disease candidates. The FDA accepted both treatment protocols, which means that the drugs are available for the treatment of Gaucher patients prior to their commercialization.
 
We believe the temporary availability of velaglucerase alfa will give physicians the opportunity to become familiar with the product prior to its commercial launch. Moreover, positive results from a head-to-head study comparing velaglucerase alfa with Cerezyme could help the former gain share from Cerezyme.
 
While we expect a response from the European regulatory authority on the approval status of velaglucerase alfa in the first half of 2010, a response from the FDA should be out by Feb 28, 2010.
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