Allergan and MAP Pharmaceuticals Announce Collaboration on LEVADEX™ Investigational Therapy for Acute Migraine
January 31 2011 - 8:00AM
Business Wire
Allergan, Inc. (NYSE:AGN) and MAP Pharmaceuticals, Inc.
(Nasdaq:MAPP) 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.
MAP Pharmaceuticals Conference Call / Webcast Details
To participate in the live call today, on Monday, January 31, at
8:30 a.m. Eastern Time (5:30 a.m. Pacific Time), please dial
877-280-7473 for domestic callers and 707-287-9370 for
international callers. Individuals interested in listening to the
call via webcast may do so by visiting the Investor Relations page
of http://www.mappharma.com.
About LEVADEX™ Investigational Acute Migraine Therapy
LEVADEX™ is an investigational therapy for acute migraine that
has completed Phase III clinical development. In the clinical
trial, patients administered LEVADEX™ themselves using the
proprietary TEMPO® inhaler. LEVADEX™ contains a novel formulation
of dihydroergotamine (DHE). LEVADEX™ was evaluated in the efficacy
portion of FREEDOM-301, MAP Pharmaceuticals’ Phase III pivotal
trial, which included 395 patients in the LEVADEX™ arm and 397
patients in the placebo arm. In the Phase III trial, patients
taking LEVADEX™ therapy had statistically significant improvement
at two hours compared to patients on placebo for all four
co-primary endpoints:
• Pain relief: 58.7 percent of patients who received
LEVADEX™ compared with 34.5 percent for placebo (p
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