Allergan, Inc. and MAP Pharmaceuticals, Inc. have announced a collaboration
within the United States
for LEVADEX(TM), 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(TM) with the United States Food and Drug Administration (FDA)
in the first half of 2011.
LEVADEX(TM) 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(R) inhaler, the
unique formulation can be self-administered by the patient and is absorbed
through the lungs. If approved, LEVADEX(TM) 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(TM), Allergan and MAP Pharmaceuticals will co-promote LEVADEX(TM)
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(R) 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(TM) outside the United States,
as well as to primary care physicians within the United States.