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Jazz Pharmaceuticals plc
Drug Names(s): ARL-N05, ADX-N05, SKL-N05
Description: ADX-N05 is an optically pure phenylalanine derivative. The precise mechanism of ADX-N05 has not been specified, but the compound is thought to engage multiple neurotransmitters, including dopamine and noradrenalin.
In preclinical studies, ADX-N05 has shown comparable efficacy with Modafinil as well as a safe toxicological profile. It shows a dose-dependent increase in wakefulness with no immediate non-REM rebound. It has also shown the potential to treat the associated symptom of cataplexy (suppressing DREM, the direct transition from wakefulness to an REM sleep state), an abrupt and temporary episode of weakness that can result in collapse. The drug has also shown efficacy in models of depression.
Addrenex and SK
In May 2009, Addrenex signed an agreement to license ADX-N05 for the treatment of narcolepsy, as well as other neurologic and psychiatric conditions. The agreement to license gives Addrenex the worldwide rights (excluding East Asia) to develop, manufacture and commercialize the compound from SK Life Science Business Division, the drug-discovery and development division of SK Holdings.
Under the terms of the contract, Addrenex will pay licensing fees and royalties to SK Holdings, as well as milestone payments for achieving specific clinical endpoints and sales performance goals.
SK retains rights to ADX-N05 in Korea, Japan, China, Taiwan, Singapore, Indonesia, India, Philippines, Thailand, Malaysia, Vietnam and Hong Kong.
Sciele (Shionogi) and Addrenex
In November 2009, Sciele Pharma, a subsidiary of Shionogi & Co., acquired Addrenex.
Aerial and Addrenex
In December 2011, a Phase II study of ADX-N05...See full deal structure in Biomedtracker
Partners: SK Biopharmaceuticals Co., Ltd. Shionogi & Co. Ltd. Aerial BioPharma, LLC
Pink Sheet FDA Performance Tracker: User Fee Goal Dates
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