GlaxoSmithKline expands Fabry disease deal with Amicus, upping stake in the firm

Moving forward with its foray into the rare disease sector, UK pharma giant GlaxoSmithKline (LSE: GSK) and USA-based biotech firm Amicus Therapeutics (Nasdaq: FOLD) expanded their collaboration to develop and commercialize the investigational pharmacological chaperone migalastat HCl, trade name Amigal, for Fabry disease. The expanded alliance comprises three components:

* co-development of all current and future formulations of migalastat for Fabry disease, including a co-formulation of migalastat HCl with GSK/JCR Pharmaceutical’s investigational enzyme replacement therapy (ERT) for Fabry disease;

 * commercialization arrangements for all future Fabry products. Amicus will have commercial rights to all Fabry products in the USA while GSK will do likewise in the rest of world; and

 * increased GSK ownership in Amicus with an $18.6 million investment in common stock priced at $6.30 per share, bringing GSK’s total ownership stake in Amicus to 19.9%.

Under the terms of the original accord, in return for an upfront payment $30 million, GSK received an exclusive worldwide license to develop, manufacture and commercialize Amigal (The Pharma Letter November 1, 2010). GSK also agreed to pay around $170 million on the successful achievement of development and commercialization milestones, as well as tiered double-digit royalties on global sales of migalastat.