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Zomig

Impax Laboratories, Inc.

Drug Names(s): zolmitriptan, Zomig-ZMT (orally disintegrating tablets), Zomig Nasal Spray

Description: Zomig is a triptan that binds with high affinity to human recombinant 5-HT1D and 5-HT1B receptors. Zolmitriptan exhibits modestaffinity for 5-HT1A receptors, but has no significant affinity (as measured by radioligand binding assays) or pharmacological activity at 5-HT2, 5-HT3, 5-HT4, alpha1-, alpha2- or beta1-adrenergic; H1, H2, histaminic; muscarinic;dopamine1, or dopamine2 receptors. The N-desmethyl metabolite also has high affinity for 5-HT1B/1D and modest affinity for 5-HT1A receptors.

Migraine headaches are thought to be caused by local cranial vasodilatation and/or release of sensory neuropeptides (vasoactive intestinal peptide, substance P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. Zomig is thought to work by agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels andsensory nerves of the trigeminal system which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Deal Structure: In February 2012, Impax announced that it licensed from AstraZeneca the exclusive United States (U.S.) commercial rights to Zomig (zolmitriptan) tablet, orally disintegrating tablet, and nasal spray formulations. As part of a Distribution, License, Development and Supply Agreement, Impax will also have non-exclusive rights to develop new products containing zolmitriptan and to exclusively commercialize these products in the U.S. in connection with the Zomig brand. Under terms of the Agreement, Impax will pay AstraZeneca quarterly payments totaling $130 million during 2012, and thereafter, Impax will pay AstraZeneca tiered royalties on future sales of zolmitriptan products. Impax will receive the benefit of the gross profit on U.S. Zomig sales commencing from January 1, 2012.

Partners: AstraZeneca PLC


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