Amicus reacquires migalastat rights, acquires Callidus

Amicus Therapeutics Inc. (NASDAQ:FOLD) announced two deals, a financing and a headcount reduction Wednesday, positioning itself to fund an enzyme replacement pipeline through 2015. Amicus reacquired rights to migalastat, its Fabry's disease therapy, from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Under a July 2012 amendment to a 2010 deal, Amicus and GSK were co-developing migalastat worldwide, and GSK had ex-U.S. commercialization rights. Amicus also reacquired rights to a co-formulation of migalastat with a preclinical GSK enzyme-replacement therapy (ERT). GSK is eligible for under $40 million in milestones from Amicus for migalastat as monotherapy, plus tiered royalties in the mid-teens for sales in the U.K., France, Spain, Italy, Germany, Brazil, Australia, and Japan. GSK is eligible for under $10 million in milestones for the migalastat/ERT co-formulation, plus single-digit royalties in the eight markets. Migalastat, a small molecule that enhances alpha galactosidase A activity, is in Phase III testing for Fabry's disease.

Amicus also acquired preclinical company Callidus Biopharma Inc. (Doylestown, Pa.) for $15 million in Amicus stock and up to $115 million in milestones. Callidus is developing ERTs for lysosomal storage disorders. The company's lead ERT -- which comprises Callidus' variant IGF-2 conjugated to recombinant human acid alpha glucosidase ( rhGAA) -- is in preclinical development for Pompe's disease (see BioCentury, Sept. 30). ...