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Amicus Therapeutics And GSK Announce Revised Fabry Agreement

Stocks in this article: FOLD

Amicus Acquires Full Rights to Global Drug Development, Regulatory and Commercial Activities for Migalastat HCl

GSK Retains Interest through Additional Equity Investment in Amicus, and Future Milestones and Royalties

Conference Call Today at 5:00 p.m. ET

CRANBURY, N.J. and LONDON, Nov. 20, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline (GSK) today announced that Amicus has obtained global rights to develop and commercialize the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.

Key Highlights of Revised Agreement:

  • Amicus will have sole rights to the global drug development, regulatory and commercial activities for the next-generation Fabry ERT (migalastat HCl co-formulated with ERT) as well as migalastat HCl monotherapy.
  • GSK will be eligible for future regulatory and commercial milestone payments, as well as royalty payments.
  • GSK will further invest $3 million in Amicus through an equity investment in a concurrent private placement in public equity (PIPE) transaction.

Under the terms of the revised agreement, there is no upfront payment from Amicus to GSK. For the next-generation Fabry ERT, GSK is eligible to receive single-digit royalties on net sales in eight major markets outside the U.S. For migalastat HCl monotherapy, GSK is eligible to receive post-approval and sales-based milestones, as well as tiered royalties in the mid-teens in eight major markets outside the United States. The terms of the revised agreement replace the prior agreement in its entirety. Under the prior agreement entered into in July 2012, Amicus and GSK were co-developing migalastat HCl globally and GSK had rights to commercialize migalastat HCl outside the U.S.

Moncef Slaoui, Chairman of GSK R&D, commented, "With internal expertise and established relationships within the rare disease community, we believe Amicus is well positioned to maintain momentum of the programs, maximizing their potential for success, which we hope will provide benefits to patients living with Fabry disease. GSK will continue to support Amicus through our equity investment and share in the future value of migalastat HCl as the Fabry program meets certain regulatory and sales milestones."

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