Allergan, Inc. and MAP Pharmaceuticals, Inc. today announced a collaboration within the United States for LEVADEX™, a self-administered, orally inhaled therapy that has completed Phase III clinical development for the treatment of acute migraine in adults. MAP Pharmaceuticals currently anticipates submitting its New Drug Application (NDA) for LEVADEX™ with the United States Food and Drug Administration (FDA) in the first half of 2011.
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 Pharmaceuticals' 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, LEVADEX™ may offer an easy to use, at-home therapy option for acute migraine sufferers.
Under the terms of the collaboration, following potential FDA approval of LEVADEX™, Allergan and MAP Pharmaceuticals will co-promote LEVADEX™ to neurologists and pain specialists in the United States. Specifically, Allergan will leverage its existing U.S. sales force dedicated to headache specialists using BOTOX® for Chronic Migraine, which will be complemented by MAP Pharmaceuticals' field sales force targeting neurologists and pain specialists. MAP Pharmaceuticals will retain all rights to commercialize LEVADEX™ outside the United States, as well as to primary care physicians within the United States.
"As a company devoted to the advancement of patient care in specialty areas, including neurosciences, we are pleased to partner with MAP Pharmaceuticals to realize the potential of LEVADEX™," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "If approved by the FDA, LEVADEX™ would present a continuum of care to neurologists and pain specialists, LEVADEX™ for acute migraine patients and BOTOX® for Chronic Migraine patients."
"Allergan is an established leader in neurosciences with a proven track record of scientific innovation, securing FDA approvals and commercializing products to neurologists and pain specialists in the United States," said Timothy S. Nelson, MAP Pharmaceuticals' President and Chief Executive Officer. "Their commitment to neurosciences and their understanding of the needs of our target physicians for LEVADEX™ have been demonstrated through the ongoing evolution of BOTOX®, including its recent FDA approval for Chronic Migraine patients. They are the ideal partner to help us best serve this specialty segment and to provide the resources needed to successfully launch and commercialize LEVADEX™ upon potential FDA approval."
As part of the collaboration, MAP Pharmaceuticals will be responsible for the manufacturing and distribution of LEVADEX™ in the United States, and for recording product revenue. Leveraging Allergan's expertise in pursuing innovation and securing market authorization, the companies have also agreed, following potential approval of LEVADEX™ for the treatment of acute migraine in adults, to jointly develop LEVADEX™ for additional indications, including adolescent migraine and one additional headache disorder. The companies will work through joint committees to manage all development and commercial activities. MAP Pharmaceuticals will be responsible for obtaining NDA approval, and will retain ownership of the NDA.
MAP Pharmaceuticals 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 LEVADEX™ generated from its commercialization to neurologists and pain specialists in the United States.
WHO calls for urgent action on rising neurological conditions worldwide