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Shire PLC has sent its treatment for Gaucher disease, an alternative to Genzyme’s Cerezyme drug, to the FDA for approval.
Shire, whose Human Genetic Therapies division is headquartered in Lexington, has accelerated the development of the drug in the wake of Genzyme’s Cerezyme shortage, which was caused by the discovery of a virus at the Cambridge-based company’s Allston manufacturing plant. Shire received a treatment protocol for its drug last month, allowing the company to make the drug available before being approved by the FDA.
Shire’s therapy is a treatment for Type 1 Gaucher disease. Adults with this type of the disease are currently excluded from receiving the Genzyme drug, due to the shortage, except in rare circumstances of acute illness. Shire executives said that the company had originally planned to submit the drug to the FDA next year but accelerated the timeline following the Genzyme shortage. Shire will provide the treatment free of charge, under the treatment protocol, until it is approved.
“The submission of the (new drug application) for velaglucerase alfa, earlier than previously announced, is an important milestone for Shire, bringing us another step closer to providing a new treatment option for patients with Type 1 Gaucher disease,” Sylvie Grégoire, president of Shire Human Genetic Therapies, said in an interview.
Gregoire said Shire is on track to submit the drug to European regulators by the end of 2009. Company officials said they would hold off on making any changes to the company’s financial guidance, given the accelerated drug development, until third quarter results are released in October.
Shire’s (Nasdaq:SHPGY) stock was trading at $50.30 in morning trading on Tuesday, up from $49.56 at the previous close.
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