Migraines are a headache. However, a new inhalable treatment is heading to the FDA for full approval before July 2011. Allergan, Inc. and MAP Pharmaceuticals will collaborate promotions of LEVADEX, a self-administered, orally inhaled therapy for migraines in a substantial $160 million deal.

Upon FDA approval, Allergan will leverage its existing U.S. sales force currently pushing BOTOX for Chronic Migraine to headache specialists with MAP Pharmaceuticals’ field sales force targeting neurologists and pain specialists doubling the reach opportunity.

David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer 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. 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.”

Approximately 45 million Americans suffer from chronic headaches, and of them, 28 million suffer from migraines. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.

According to the National Headache Foundation, most migraines last between four and 24 hours, but some last as long as three days. On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25% of them experience one or more attacks weekly.

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.

Timothy S. Nelson, MAP Pharmaceuticals’ President and Chief Executive Officer continues:

“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. 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.”

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.

Many breakthroughs regarding the biological and genetic causes of migraines have been made in recent years. And while certain exact biological mechanisms are still being studied, it is known that migraine is caused by neurological, not psychological, mechanisms. Hence, breakthroughs in treatment offer hope and relief for millions of people who suffer from the physical and emotional pain of migraine.

Source: Allergan

Written By Sy Kraft, B.A.