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Amicus Therapeutics Gains 3% On Favorable EU Medicines Recommendation

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Shares of Amicus Therapeutics, Inc. (NASDAQ: FOLD), a bio-pharmaceutical company that focuses on the treatment of rare and orphan diseases, were trading higher by 3 percent Friday afternoon.

Amicus Therapeutics announced earlier in the day that the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to approve the oral small molecule pharmacological chaperone migalastat as a first line therapy for Fabry disease in all patients who have an amenable genetic mutation.

Amicus Therapeutics added that the European Commission is expected to make a final decision in the second quarter of 2016. If the company obtains a favorable decision, it will begin a country-by-country reimbursement process.

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"This positive CHMP opinion for migalastat is a huge milestone for the Fabry community and a significant step towards our vision to become a leading global biotechnology company focused on rare and devastating diseases," said John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. "Oral migalastat represents a groundbreaking approach to personalized medicine. We are very pleased that the CHMP has adopted a positive opinion to approve migalastat with a broad label that includes all 269 amenable mutations screened through our Amenability Assay, as well as a fully searchable Amenability website for physicians.

"These amenable genetic mutations are represented in an estimated 35 percent to 50 percent of the diagnosed Fabry population today, which is a significant opportunity for Amicus to deliver a therapy option for many patients in need. We are grateful for the ongoing support from the Fabry community to advance migalastat, in particular those patients who participated in the clinical studies of migalastat and their families. Our world-class commercial and business leadership team is already in place in key launch countries in Europe, and we look forward to a final EC decision in the coming months. We are fully prepared and sharply focused on the launch of migalastat to complete our transformation into a global commercial organization."

At time of writing, Amicus was up 1.66 percent at $8.59.

 

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