MAP Pharmaceuticals Initiates Phase 3 Clinical Trial in Patients With Migraine

MOUNTAIN VIEW, Calif., July 14 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced it has initiated its
Phase 3 clinical program to evaluate MAP0004 as a potential treatment for
migraine.
MAP0004 is orally inhaled and self-administered at home using MAP
Pharmaceuticals' proprietary Tempo(R) inhaler. In the company's prior Phase 2
efficacy study, MAP0004 provided pain relief in as fast as 10 minutes, with
relief sustained through at least 24 hours. The study also demonstrated
efficacy trends in treating nausea, photophobia and phonophobia, the other key
measurements in treating migraine.
This randomized, double-blind, placebo-controlled Phase 3 trial is
designed to evaluate the efficacy and safety of MAP0004 in treating acute
migraine. The primary efficacy endpoints will be pain relief, and freedom
from nausea, photophobia and phonophobia as measured at two hours after
dosing. MAP will also evaluate earliest onset of pain relief and sustained
relief to 24 and 48 hours. The multi-center efficacy trial will include
approximately 850 patients, who will also be followed for 12 months in an
open-label study to confirm long-term safety.
"We believe that MAP0004 has the potential to be a first-line therapy for
migraine patients," said Timothy S. Nelson, president and chief executive
officer of MAP Pharmaceuticals. "Based on our initial clinical studies, we
believe that MAP0004 offers an alternative to triptans that may provide
patients with the benefits of rapid onset and long-lasting pain relief, in an
easy-to-use, non-invasive, at-home therapy. In our Phase 2 trials, MAP0004
was well tolerated with no effect on pulmonary function, including in
asthmatic subjects."
The therapeutic agent in MAP0004 is dihydroergotamine (DHE), which has a
long history of use as a safe and effective migraine treatment. Many headache
specialists consider DHE administered by injection to be the standard of care
in treating chronic migraine and debilitating migraines that last more than 72
hours. MAP Pharmaceuticals is seeking to expand the use of this compound to
treat migraines early, non-invasively and with a fast onset of action.
MAP Pharmaceuticals is initiating the first Phase 3 trial of its MAP0004
product candidate pursuant to a Special Protocol Assessment (SPA) with the
U.S. Food and Drug Administration. The SPA is intended to provide assurance
that if pre-specified trial results are achieved, they may serve as the
primary basis for an efficacy claim in support of a new drug application. In
general, these assessments are considered binding on the FDA as well as the
sponsor unless public health concerns unrecognized at the time the SPA is
entered into become evident or other new scientific concerns regarding product
safety or efficacy arise.
About Migraine
Migraine is a common, debilitating neurological disease affecting
approximately 30 million people in the United States. It presents with
recurrent attacks of headaches, nausea, vomiting and sensitivity to light and
sound. 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 percent of them experience one or more attacks weekly.
In published studies, migraine sufferers often cite faster onset of pain
relief and lower incidence of migraine recurrence as two key therapeutic
attributes they would like from their medication. Currently approved drugs
for the treatment of an acute migraine attack do not fully meet the needs of
all patients due to the slow onset of action, short duration of effect,
inconsistent response, unacceptable side effect profiles, or propensity to
increase frequency of headaches with these therapies.
In 2007, triptans, the class of drugs most often prescribed for treating
migraine, generated sales of approximately $2.2 billion in the United States,
according to data published by IMS Health. Approximately 30 to 40 percent of
migraine patients do not respond fully to triptans. Historically, estimated
onset of significant pain relief with oral triptans occurs between 45 and 90
minutes after dosing.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals develops and plans to commercialize new therapies for
children and adults who suffer from chronic conditions that it believes are
not adequately treated by currently available medicines. The company applies
its proprietary inhalation technologies to enhance the therapeutic benefits
and commercial attractiveness of proven drugs while minimizing risk by
capitalizing on their known safety, efficacy and commercialization history.
MAP Pharmaceuticals has two drug candidates in Phase 3 clinical trials. Unit
Dose Budesonide is being developed for the potential treatment of pediatric
asthma, and MAP0004 is being developed for the potential treatment of
migraine. MAP Pharmaceuticals' pipeline also includes a drug candidate in
early clinical development for the treatment of asthma and chronic obstructive
pulmonary disease.
Additional information about MAP Pharmaceuticals can be found at
http://www.mappharma.com.
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 outcomes of the MAP0004 clinical program. Actual results
may differ materially from current expectations based on risks and
uncertainties affecting MAP Pharmaceuticals' business, including, without
limitation, risks and uncertainties relating to the enrollment and conduct of
clinical trials, as well as risk related to failure to achieve favorable
clinical outcomes and that MAP0004 will not be approved for commercial use by
the U.S. Food and Drug Administration, including but not limited to approval
for use as a first line therapy. 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,
filed with the SEC on May 14, 2008, and available at http://edgar.sec.gov.
SOURCE MAP Pharmaceuticals, Inc.

Becky Soja of WeissComm Partners, +1-415-945-1080, bsoja@wcpglobal.com, for
MAP Pharmaceuticals, Inc.