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Mylan Inc.

Drug Names(s): Sublinox, OX 22, sublingual zolpidem

Description: Sublinox (OX 22) is based on Orexo’s sublingual technology, involving a tablet placed under the tongue for fast absorption of the active substance across the oral mucosa. The tablet contains the active substance 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: In April 2008, Meda announced that the Company has acquired exclusive world-wide commercialisation rights from Orexo for Sublinox. As consideration for exclusive world-wide commercialisation rights for Sublinox and OX-NLA, Meda has paid 20 MUSD. Meda has also agreed to the following one time milestone payment for Sublinox, when a yearly sales level is reached;

  • At FDA approval, 30 MUSD;
  • Sales milestones: When net sales are >150 MUSD, >200 MUSD or >400 MUSD, payment is 20 MUSD.
Orexo will receive double digit royalty on net sales. Medas gross margin for Sublinox and OX-NLA is estimated to become higher than 70%.

Valeant and Meda
In August 2008, Valeant and Meda announced that the companies have agreed to form joint ventures in Australia, Canada and Mexico to develop, market and commercialize certain current and future products. The joint ventures will be majority-owned by Meda and Valeant will own a minority interest. The joint ventures will pursue the...See full deal structure in Biomedtracker

Partners: Orexo AB Valeant Pharmaceuticals International, Inc.

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