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news.ArmaGen, a privately held biotechnology company, has announced 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.
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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, advancing ArmaGen’s proprietary pipeline of innovative therapies."
"Our agreement with ArmaGen strengthens our long-standing commitment to the Hunter syndrome community to bring forward novel therapies that have the potential to dramatically redefine the treatment paradigm and address the most critical unmet needs," said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire.
"AGT-182 has the potential to be an important new therapy to our existing portfolio of Hunter syndrome programs. We plan to apply our proven ability to develop therapies for rare genetic diseases to progress AGT-182 as a potential treatment that offers hope to patients with Hunter syndrome and their families."