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Amicus Therapeutics Launches Galafold in Italy

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March 9, 2017: Amicus Therapeutics has commenced the commercial launch of the precision medicine Galafold in Italy following the final publication of reimbursement guidelines by the Ministry of Health (Ministero della Salute). Galafold is now reimbursed in Italy as a therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. As a precision medicine, Galafold is designed to restore alpha-Gal A activity in patients who have amenable mutations (an estimated 35% to 50% of the Fabry population).

The European Commission granted full approval for Galafold on May 30, 2016, as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.

February 27, 2017: Amicus Therapeutics, a global biotechnology company at the forefront of rare and orphan diseases, has commenced the commercial launch of the precision medicine Galafold in the United Kingdom (UK) following the final publication of reimbursement guidelines by the National Institute for Health and Care Excellence (NICE) Highly Specialised Technologies Evaluation Committee (EC). Galafold is reimbursed within the National Health Service (NHS) in England as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

The European Commission granted full approval for Galafold on May 30, 2016, as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.

January 15, 2017: Hearing takeover rumors about Amicus Therapeutics. The rumors are that Shire is interested in acquiring Amicus Therapeutics. I could not confirm the source of the rumors.

January 9, 2017: Amicus Therapeutics guides FY17 net cash spend at $200 to $225 million. Cash, cash equivalents, and marketable securities totaled $331 million as of December 31, 2016.

Outlook:

Strong Momentum for Galafold Launch in Europe and Multiple Global Regulatory Submissions Ahead. Additional Data from Pompe Phase 1/2 Clinical Study and Top-Line Data from Phase 3 Epidermolysis Bullosa Study Expected in 2017.

January 4, 2017: NICE issues final positive recommendation for Galafold.

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Amicus Therapeutics is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases.

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Trading The News: Amicus Therapeutics In The News