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ZolpiMist

Amherst Pharmaceuticals, LLC

Drug Names(s): Ambien oral spray, Zolpidem oral spray

Description: Zolpidem oral spray is an oral spray formulation of Ambien (zolpidem). Zolpidem is a short-acting hypnotic agent with a chemical structure unrelated to benzodiazepines. It binds, however, to the benzodiazepine receptor, which is the major modulatory site of the GABA-A receptor complex located on its alpha subunit. Zolpidem potentiates gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter. Subunit modulation of the GABA-A complex is thought to be responsible for sedative, anticonvulsant, anxiolytic, and myorelaxant drug properties.

Deal Structure: Hi-Tech Pharmacal and NovaDel
In November 2009, Hi-Tech Pharmacal announced the signing of an exclusive licensing agreement between Hi-Tech's ECR Pharmaceuticals subsidiary and NovaDel Pharma through which ECR obtained the rights to market zolpidem tartrate oral spray, 5mg per spray, in the United States and Canada. Under the terms of the agreement ECR paid NovaDel $3 million upon closing. In addition NovaDel will receive a royalty of up to 15% on net sales, and a milestone payment if net sales reach a specific level in a calendar year.

NovaDel and Rechon Life Science
In August 2011, NovaDel announced its entry into an exclusive license and distribution agreement with Rechon Life Science AB to manufacture and commercialize Zolpimist outside the United States and Canada. Under the terms of the agreement, Rechon will assume responsibility for manufacturing and marketing Zolpimist outside the United States and Canada. In addition, Rechon will pay a royalty...See full deal structure in Biomedtracker

Partners: NovaDel Pharma, Inc. Rechon Life Science Akorn Inc.


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