Allergan and MAP Pharmaceuticals Announce Collaboration on LEVADEX™ Investigational Therapy for Acute Migraine
-- Collaboration Intended to Expand Continuum of Care for Migraine
Patients and Portfolio Offering to Neurologists and Pain Specialists in
United States --
IRVINE, Calif. & MOUNTAIN VIEW, Calif.--(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<0.0001);
Phonophobia free: 52.9 percent of patients who received LEVADEX™
compared with 33.8 percent for placebo (p<0.0001);
Photophobia free: 46.6 percent of patients who received LEVADEX™
compared with 27.2 percent for placebo (p<0.0001); and
Nausea free: 67.1 percent of patients who received LEVADEX™ compared
with 58.7 percent for placebo (p=0.02).
The most common adverse event reported was medication aftertaste at six
percent versus two percent for placebo. The next most common adverse
event was nausea at five percent compared with two percent for placebo.
There were no decreases in lung function, as measured by spirometry,
between the active and placebo groups.
Common symptoms of migraine include recurrent headaches, nausea,
vomiting, photophobia (sensitivity to light) and phonophobia
(sensitivity to sound). According to the National Headache Foundation,
most migraines last between four and 24 hours, but some last as long as
three days.1 On average, migraine sufferers experience 1.5
migraine attacks monthly, although 25 percent of them experience one or
more attacks weekly.2 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
About BOTOX® (onabotulinumtoxinA) Important Information
BOTOX® is a prescription medicine that is injected into muscles and used:
to treat headaches in adults with Chronic Migraine (15 or more days
with headaches lasting four hours a day or longer) in people 18 years
to treat increased muscle stiffness in elbow, wrist, and finger
muscles with upper limb spasticity in people 18 years and older.
to treat the abnormal head position and neck pain that happens with
cervical dystonia (CD) in people 16 years and older.
to treat certain types of eye muscle problems (strabismus) or abnormal
spasm of the eyelids (blepharospasm) in people 12 years and older.
BOTOX® is also injected into the skin to treat the symptoms of severe
underarm sweating (severe primary axillary hyperhidrosis) when medicines
used on the skin (topical) do not work well enough in people 18 years
It is not known whether BOTOX® is safe or effective to
prevent headaches in patients with migraine who have 14 or fewer
headache days each month (episodic migraine).
It is not known whether BOTOX® is safe or effective for other
types of muscle spasms or for severe sweating anywhere other than your
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening.
Call your doctor or get medical help right away if you have any of these
problems any time (hours to weeks) after injection of BOTOX®:
Problems swallowing, speaking, or breathing, due to weakening
of associated muscles, can be severe and result in loss of life. You
are at the highest risk if these problems are pre-existing before
injection. Swallowing problems may last for several months.
Spread of toxin effects. The effect of botulinum toxin may
affect areas away from the injection site and cause serious symptoms
including: loss of strength and all-over muscle weakness, double
vision, blurred vision and drooping eyelids, hoarseness or change or
loss of voice (dysphonia), trouble saying words clearly (dysarthria),
loss of bladder control, trouble breathing, trouble swallowing.
There has not been a confirmed serious case of spread of toxin effect
away from the injection site when BOTOX® (onabotulinumtoxinA) has been
used at the recommended dose to treat Chronic Migraine, severe underarm
sweating, blepharospasm, or strabismus.
Do not take BOTOX® if you: are allergic to any of the ingredients
in BOTOX® (see Medication Guide for ingredients); had an allergic
reaction to any other botulinum toxin product such as Myobloc® or
Dysport™; have a skin infection at the planned injection site.
For more information refer to the Medication Guide or talk with your
doctor. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
For more information on BOTOX® (onabotulinumtoxinA) please see BOTOX®
full Product Information, including Medication Guide. Full Product
Information, including Medication Guide has been provided to your doctor
About MAP Pharmaceuticals
MAP Pharmaceuticals is an emerging biopharmaceutical company focused on
developing and commercializing new therapies to address undermet patient
needs in neurology. The Company is developing LEVADEX™ orally inhaled
therapy for the potential treatment of migraine and has reported
positive results from the efficacy portion of its Phase 3 trial of
LEVADEX™. In addition, MAP Pharmaceuticals generates new pipeline
opportunities by applying its proprietary drug particle and inhalation
technologies to enhance the therapeutic benefits of proven drugs, while
minimizing risk by capitalizing on their known safety, efficacy and
commercialization history. Additional information about MAP
Pharmaceuticals can be found at http://www.mappharma.com
About Allergan, Inc.
Allergan is a multi-specialty health care company established 60 years
ago with a commitment to uncover the best of science and develop and
deliver innovative and meaningful treatments to help people reach their
life's potential. Today, we have more than 9,000 highly dedicated and
talented employees, global marketing and sales capabilities with a
presence in more than 100 countries, a rich and ever-evolving portfolio
of pharmaceuticals, biologics and medical devices, and state-of-the-art
resources in R&D, manufacturing and safety surveillance that help
millions of patients see more clearly, move more freely and express
themselves more fully. From our beginnings as an eye care company to our
focus today on several medical specialties, including ophthalmology,
neurosciences, obesity, urologics, medical aesthetics and dermatology,
Allergan is proud to celebrate 60 years of medical advances and proud to
support the patients and physicians who rely on our products and the
employees and communities in which we live and work.
MAP Pharmaceuticals Forward-Looking Statements
In addition to statements of historical facts or statements of current
conditions, this press release contains forward-looking statements,
including with respect to the timing of the submission of the New Drug
Application for MAP Pharmaceuticals' LEVADEX™ product candidate and the
potential benefits from the collaboration between MAP Pharmaceuticals
and Allergan. Actual results may differ materially from current
expectations based on risks and uncertainties affecting the Company's
business, including, without limitation, risks and uncertainties
relating to clinical trials, the preparation and filing of a New Drug
Application and the regulatory process to have the Company's LEVADEX™
product candidate approved for commercial use, the availability, pricing
and marketing of competitive products, including generic products, any
inability to realize all of the anticipated benefits of the
collaboration arrangement fully or on the anticipated timeline, a
downturn in the pharmaceutical industry and unexpected variations in
market growth and demand for migraine products. The reader is cautioned
not to unduly rely on the forward-looking statements contained in this
press release. MAP Pharmaceuticals expressly disclaims any intent or
obligation to update these forward-looking statements, except as
required by law. Additional information on potential factors that could
affect MAP Pharmaceuticals' results and other risks and uncertainties
are detailed in its Quarterly Report on Form 10-Q for the quarter ended
September 30, 2010, available at http://edgar.sec.gov.
Allergan Forward-Looking Statements
This press release contains "forward-looking statements," including, but
not limited to, the statements by David E.I. Pyott and Timothy S. Nelson
and other statements regarding clinical trials, the preparation and
filing of a New Drug Application for LEVADEX™, FDA approval of LEVADEX™,
manufacturing, distribution and sales of LEVADEX™ as well as the safety,
effectiveness, approvals, adverse events and market potential of
LEVADEX™, BOTOX® and BOTOX® Cosmetic. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from Allergan's expectations and projections.
Risks and uncertainties include, among other things, general industry
and pharmaceutical market conditions; technological advances and patents
attained by competitors; challenges inherent in the research and
development and regulatory processes; challenges related to product
marketing, such as the unpredictability of market acceptance for new
products and/or the acceptance of new indications for such products;
inconsistency of treatment results among patients; general economic
conditions; and governmental laws and regulations affecting domestic and
foreign operations. Allergan expressly disclaims any intent or
obligation to update these forward-looking statements except as required
by law. Additional information concerning the above-referenced risk
factors and other risk factors can be found in Allergan's public
periodic filings with the Securities and Exchange Commission, including
the discussion under the heading "Risk Factors" in Allergan's 2009
Annual Report on Form 10-K and subsequent Quarterly Reports on Form
10-Q. Additional information about Allergan is available at www.allergan.com
or you can contact the Allergan Investor Relations Department by calling
© 2011 Allergan, Inc. Irvine, CA 92612 and MAP
Pharmaceuticals, Inc. Mountain View, CA 94043.
BOTOX® is a registered trademark owned by Allergan, Inc.
TEMPO® is a registered trademark owned by MAP Pharmaceuticals, Inc.
LEVADEX™ is a trademark owned by MAP Pharmaceuticals, Inc.
1 Lipton, et al. Migraine Diagnosis and Treatment:
Results From the American Migraine Study II. Headache.
2 Lipton, et al. Prevalence and Burden of Migraine in the
United States: Data from the American Migraine Study II. Headache.
3 Hawkins, K, Wang, S, Rupnow, MFT. Direct Cost Burden
Among Insured US Employees With Migraine. Headache. 2008;48:553-563.
4 Hawkins, K, Wang, S, Rupnow, MFT. Indirect Cost Burden
of Migraine in the United States. J Occup Environ Med.
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MAP Pharmaceuticals Contacts
Caroline Van Hove, 714-246-5134 (media)
Muilenburg, 714-246-5842 (media)
Jim Hindman, 714-246-4636
Joann Bradley, 714-246-4766 (investors)
Source: Allergan, Inc.
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