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Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
Date:8/5/2009

nical trials to assess the efficacy and safety of VYVANSE as adjunctive therapy in depression, for the treatment of negative symptoms and cognitive impairment in schizophrenia, and for the treatment of cognitive impairment in depression. Velaglucerase alfa - for the treatment of Gaucher disease - On July 16, 2009 Shire announced that it had received Fast Track designation from the FDA for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher disease. On July 30 Shire began the rolling submission of a NDA for velaglucerase alfa to treat patients with Type 1 Gaucher disease. Fast Track is a process which expedites the review of drugs to treat serious diseases and fill an unmet medical need with the goal of getting important new treatments to patients earlier. Shire will file additional sections of the NDA as they become available. Results from the first of the three Phase 3 trials were positive, and achieved statistically significant improvements in the primary endpoint. Velaglucerase alfa was also found to be well tolerated with no drug related serious adverse events reported in this trial. - On August 3, 2009 Shire announced that it had received approval from the FDA on the initiation of a treatment protocol for velaglucerase alfa. This protocol was submitted at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher disease patients. This will allow physicians to treat Gaucher disease patients with velaglucerase alfa ahead of commercial availability in the US. Under the conditions of the treatment protocol, Shire will provide velaglucerase alfa free of charge initially, in order to provide access to patients as quickly as possible.

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