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July 23, 2014
07:28 EDTSHPGShire enters licensing and collaboration agreement with ArmaGen
Shire and ArmaGen, a US privately held biotechnology company, 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. Shire will obtain worldwide commercialization rights for AGT-182 in exchange for payments of approximately $225M to ArmaGen, including an initial upfront payment of $15M 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.
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July 23, 2015
14:01 EDTSHPGShire receives 'positive opinion' on Intuniv from CHMP
Shire announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of the once-daily, non-stimulant Intuniv, or guanfacine hydrochloride extended release, for the treatment of attention deficit/hyperactivity disorder in children and adolescents. The positive opinion is based on results from three Phase 3 pivotal studies investigating the short- and long-term safety and efficacy of Intuniv in children and adolescents. The European Commission will now consider the CHMP positive opinion in its decision of whether to grant marketing authorisation for Intuniv in Europe, said Shire.
07:25 EDTSHPGShire raises FY15 EPADS growth view to mid-to-high single digit percentage
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07:22 EDTSHPGShire reports Q2 EPS $2.63, consensus $2.81
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