Date: 2015-06-15
Type of information: Milestone
Compound: AGT-182
Company: Shire (UK-USA) Armagen Technologies (USA - CA)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: licensing collaboration
Action mechanism: enzyme replacement therapy. AGT-182 is an enzyme replacement therapy (ERT) which has received orphan drug designation from both the FDA and the European Medicines Agency (EMA). AGT-182 is engineered by the fusion of the replacement iduronate-2-sulfatase enzyme to an antibody that binds to a receptor on the brain blood barrier (BBB). The IDS enzyme is designed to cross the BBB attached to that antibody.
Disease: Hunter syndrome or mucopolysaccharidosis type II (MPS II)
Details: * On July 23, 2014, Shire and ArmaGen, a US privately held biotechnology company, 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). As part of the agreement, 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.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.
Four products have received orphan drug designation in the US for the treatment of Hunter syndrome. Two of them (Elaprase® [idursulfase] and idursulfase IT belong to Shire. The third one, HIRMAb-IDS, is Armagen\'s product and the Korean group Green Cross has also been granted orphan drug status for its idursulfase beta.
Financial terms: Under the terms of the agreement, 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.
Latest news: * On June 15, 2015, ArmaGen announced that it achieved a clinical milestone in its worldwide licensing and collaboration agreement with Shire. The milestone was achieved in conjunction with dosing patients in its Phase 1 clinical trial of AGT-182, an investigational treatment of Hunter syndrome, and under terms of the agreement, the Company is entitled to a milestone payment from Shire. The primary objective of the Phase 1 trial is to test the safety and determine a well-tolerated dose of AGT-182, an investigational enzyme replacement therapy (ERT), in adult patients with Hunter syndrome. ArmaGen plans to enroll 12 patients 18 years and older into the study. These patients will be treated for a total of eight weeks, with all enrolled patients receiving AGT-182 (NCT02262338).
