US drugmakers Allergan (NYSE: AGN) and MAP Pharmaceuticals (Nasdaq: MAPP) have entered a collaboration within the USA for Levadex (dihydroergotamine), a self-administered, orally inhaled therapy that has completed Phase III clinical development for the treatment of acute migraine in adults. MAP currently anticipates submitting its New Drug Application for Levadex with the Food and Drug Administration in the first half of 2011.
MAP will receive a $60 million up-front payment from Allergan and up to $97 million in additional payments upon meeting certain regulatory milestones associated with the initial indication. If Levadex receives FDA approval, the companies will equally share profits from sales of the product generated from its commercialization to neurologists and pain specialists in the USA.
Levadex contains a proprietary formulation of dihydroergotamine (DHE), a drug delivered via IV, injection or nasal spray and used in clinical practice today for the treatment of acute migraine. Utilizing MAP’s proprietary drug delivery system, the TEMPO inhaler, the unique formulation can be self-administered by the patient and is absorbed through the lungs. If approved, it may offer an easy to use, at-home therapy option for acute migraine sufferers, the companies said.
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