Shire drug hits endpoints, heads to patients

Genzyme's struggles with production of its Gaucher disease drug Cerezyme are a boon to Shire Pharmaceuticals. Today the drugmaker announced that a velaglucerase alfa hit endpoints in a Phase III trial, and that the FDA would allow doctors to begin prescribing the drug to make up for shortages of Genzyme's treatment. Shire also said it began a rolling submission for its NDA of Vela, as the drug is known, and that its NDA would be completed by the end of the third quarter.

Genzyme's halted production of Cerezyme in mid-June after it was discovered that a virus had contaminated its Boston production facility, though production has since resumed. The drug brought in $1.2 billion for Genzyme last year.

"We are very pleased with the progress of the velaglucerase alfa program from both a clinical and regulatory perspective," said Sylvie Grégoire, President of Shire Human Genetic Therapies. "This data are consistent with those previously reported from the Phase I/II and extension studies. We will continue to work diligently with the FDA and other regulatory agencies to make velaglucerase alfa available as soon as possible to help meet the needs of the Gaucher community."

- check out Shire's release
- see the article from the WSJ

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