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ArmaGen Announces Strategic Licensing and Collaboration Agreement with Shire to Develop AGT-182 for Treatment of Hunter Syndrome
Date:7/23/2014

CALABASAS, Calif., July 23, 2014 /PRNewswire/ -- ArmaGen, a privately held biotechnology company focused on developing revolutionary therapies to treat severe neurological disorders, announced today that it has entered into a worldwide licensing and collaboration agreement with Shire plc to develop AGT-182, an investigational enzyme replacement therapy (ERT) for potential treatment of both the central nervous system (CNS) and somatic (body-related) manifestations of Hunter syndrome. Also known as MPS II, Hunter syndrome is a rare, severe, progressive and life-limiting lysosomal storage disorder.

Under the agreement, Shire receives worldwide commercialization rights for AGT-182. ArmaGen will receive payments up to approximately $225 million, including an initial upfront payment of $15 million in cash and equity, an additional equity investment, R&D funding, development and sales milestones, in addition to future royalties up to double digits. The collaboration between ArmaGen and Shire on AGT-182 will be managed by a joint steering committee, with representatives from both companies. ArmaGen will be responsible for conducting a Phase 1/2 study of AGT-182 and expects to initiate the trial before the end of 2014. Shire will be responsible for further clinical development, including Phase 3 trials, registration and commercialization of AGT-182 worldwide.

"The agreement with Shire validates the clinical potential of ArmaGen's lead therapy and its ability to cross the blood-brain barrier to treat the progressive and devastating neurological complications of Hunter syndrome," said James Callaway, Ph.D., Chief Executive Officer of ArmaGen. "Shire is the ideal partner for AGT-182, based on the company's international reach and expertise in serving patients with Hunter syndrome. We look forward to beginning our Phase 1/2 clinical trial of AGT-182 in collaboration with Shire and, in parallel, ad
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