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And receives milestone payment under the alliance with GlaxoSmithKline
BALLERUP, Denmark | December 3, 2007 | NeuroSearch has enrolled and dosed the first healthy volunteers in a clinical Phase I study with NSD-644 with a view to develop this drug candidate as a new treatment for pain and other disorders of the central nervous system (CNS). NSD-644 is being developed under an alliance agreement with GlaxoSmithKline (GSK), and the initiation of Phase I studies releases a milestone payment to NeuroSearch of EUR 4 million (DKK 30 million).
The Phase I study is a randomized, double-blind, placebo-controlled and sequential dose-escalation study to evaluate the safety and tolerability as well as the pharmacokinetics of NSD-644. The study will be performed in Germany.
For more than a decade, NeuroSearch has been engaged in leading preclinical and clinical drug discovery in the field of the monoamine neurotransmitters serotonin, noradrenaline and dopamine. These three neuroransmitters are critically involved in the regulation of mood, pain and anxiety. NSD-644 is a novel triple monoamine re-uptake inhibitor, increasing the effect of serotonin, noradrenalin and dopamine with a potential to treat a range of CNS disorders, including pain. NSD-644 has demonstrated robust effects in several preclinical chronic neuropathic pain models supporting this drug candidates’ potential use as a novel analgesic. GSK has accepted NSD-644 as the first development candidate under the terms of the alliance agreement.
Under the terms of the agreement with GSK, NeuroSearch retains responsibility for the clinical development of NSD-644 until completion of Proof-of-Concept (through Phase IIa), while GSK will be responsible for clinical development hereafter, as well as for production and marketing of the product. GSK will pay milestones to NeuroSearch through to market launch as well as double-digit royalties on global sales of the product.
The initiation of the Phase I study with NSD-644 and the related milestone payment from GSK of EUR 4 million does not change NeuroSearch’s financial guidance for 2007 of a loss in the range of DKK 230 - 250 million before recognition of associates and other equity interests.
SOURCE: NEUROSEARCH
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