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Amicus Therapeutics, GlaxoSmithKline Expand Fabry Disease Collaboration

Amicus Therapeutics Inc. (FOLD) and Glaxo Group Limited or GSK announced an expansion of their collaboration to develop and commercialize the investigational pharmacological chaperone migalastat HCl for Fabry disease.

Under the expanded collaboration, Amicus will commercialize all formulations of migalastat HCl in the U.S., while GSK will commercialize in the rest of the world.

Amicus and GSK said that they will continue to share research and development costs for all formulations of migalastat HCl, with Amicus funding 25% and GSK funding 75% of these costs for monotherapy and co-administration during the remainder of 2012.

Amicus and GSK will be responsible for 40% and 60% of these costs, respectively, for co-formulation immediately and for all formulations in 2013 and beyond.

GSK said it will make an $18.6 million equity investment in Amicus, bringing GSK's total ownership stake in Amicus to 19.9%. GSK will purchase about 2.95 million shares of common stock at $6.30 per share, a 7% premium over the 15-day average closing sale price of Amicus's common stock as reported by Nasdaq.

Amicus noted that it will receive a $3.5 million cash payment from GSK this quarter to reflect Amicus' achievement of a clinical development milestone during the second quarter 2012.

GSK stated that it will be eligible to receive U.S. regulatory approval and product launch milestones totaling $20 million for migalastat HCl monotherapy and chaperone-ERT co-administration.

GSK added that it will be eligible to receive additional regulatory and time-based milestone payments totaling up to $35 million within 7 years following the launch of a co-formulated chaperone-ERT product.

Amicus will also be responsible for certain additional pass-through milestone payments and single-digit royalties on the net U.S. sales of the co-formulated chaperone-ERT product that GSK must pay to a Third Party.

by RTTNews Staff Writer

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