Shire, a global specialty biopharmaceutical company, and ArmaGen, a U.S. privately held biotechnology company, have announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy (ERT) for the potential treatment of both the central nervous system (CNS) and somatic manifestations in patients with Hunter syndrome (MPS II).
Shire will obtain worldwide commercialization rights for AGT-182 in exchange for payments of approximately $225 million to ArmaGen, including an initial upfront payment of $15 million in cash and equity, an additional equity investment, R&D funding, development milestones and sales milestones, in addition to royalty payments. ArmaGen will be responsible for conducting and completing the phase I/II study, which it expects to initiate before the end of 2014, after which point Shire will be responsible for further clinical development, including phase III trials and commercialization.
Shire researched, developed and commercialized the first treatment approved for Hunter syndrome. This agreement with ArmaGen expands Shire's commitment to finding treatments for Hunter syndrome, which also includes SHP-609, Shire's product currently being investigated to treat the CNS manifestations associated with Hunter syndrome.