Amicus Therapeutics, Callidus Biopharma, GlaxoSmithKline deal

Amicus announced two deals and a headcount reduction, positioning itself to fund an enzyme replacement pipeline through 2015. Amicus reacquired rights to migalastat, its Fabry's disease therapy, from partner GlaxoSmithKline. 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 (see BioCentury, Nov. 1, 2010 & July 23, 2012).

Amicus also acquired Callidus 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. Hung Do, founder and CSO of Callidus, has been appointed SVP of discovery biology at Amicus. ...