By RTT News,
July 23, 2014, 01:12:00 PM EDT
(RTTNews.com) - Shire plc (SHP.L, SHPG) and ArmaGen, a US privately held biotechnology company, Wednesday announced a worldwide licensing and collaboration agreement for AGT-182, an investigational enzyme replacement therapy for the potential treatment of both the central nervous system and somatic manifestations in patients with Hunter syndrome.
As per the terms, Shire will obtain worldwide commercialization rights for AGT-182 in exchange for payments of about $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.
Shire said the deal strengthens its rare disease pipeline of innovative therapies where there is high unmet need, and underscores the company's long standing commitment to the Hunter syndrome community.
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.
Shire researched, developed and commercialized the first treatment approved for Hunter syndrome.
AGT-182, which has received orphan drug designation from both the U.S. Food and Drug Administration and the European Medicines Agency, is designed to take advantage of the body's natural system for transporting products across the blood brain barrier by using the same receptor that delivers insulin to the brain.
Hunter syndrome or Mucopolysaccharidosis II is a rare, life-threatening genetic disorder that results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products called mucopolysaccharides, also known as glycosaminoglycans accumulate in tissues and organs, which then begin to malfunction.
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