MAP Pharmaceuticals Provides Update on Progress of Two Phase 3 Clinical Programs

MOUNTAIN VIEW, Calif., Jan. 12 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced continued progress with
its two Phase 3 clinical programs, Unit Dose Budesonide (UDB) for children
with asthma and MAP0004 for the acute treatment of migraine. For UDB, all
patients have completed the 12 week treatment period in the initial Phase 3
clinical trial, and for MAP0004, the company currently expects to complete
enrollment in its initial Phase 3 clinical trial by the end of January 2009.
"We continue to make good progress with our Phase 3 asthma and migraine
programs and look forward to reporting data from both programs during the
first half of 2009," said Timothy S. Nelson, President and CEO of MAP
Pharmaceuticals. "We believe this clinical progress coupled with our recently
announced asthma partnership with AstraZeneca highlights the value of our
clinical approach and business strategy."
UDB Phase 3 Program
The initial UDB Phase 3 clinical trial completed enrollment in September
2008, and all patients now have completed the treatment period. This Phase 3
trial is a multi-center, randomized, double-blind, placebo controlled trial in
approximately 360 children who suffer from asthma, from 12 months to 8 years
of age. Patients received either 0.25mg UDB, 0.135mg UDB or placebo twice a
day over a 12 week treatment period. The co-primary efficacy endpoints for
the study are the change in nighttime and daytime composite symptom scores
(cough, wheeze and breathlessness). Patients enrolled in this trial will
continue to be followed in a long-term safety trial.
UDB is being studied as a novel version of nebulized budesonide.
Budesonide has been used clinically for more than 20 years. UDB is designed to
be nebulized more quickly and at a lower nominal dose than the commercially
available product. The safety data generated to date has shown UDB to be well
tolerated with no significant adverse events reported.
MAP0004 Phase 3 Program
MAP Pharmaceuticals expects to complete enrollment in its initial Phase 3
clinical trial for the acute treatment of migraine by the end of January 2009.
The Phase 3 multi-center, randomized, double-blind, placebo controlled trial
in approximately 850 migraine sufferers is evaluating MAP0004 as a potential
acute treatment for migraine. Patients enrolled in the trial will be
evaluated for the treatment of a single migraine and will continue to be
followed in a long-term safety trial. MAP Pharmaceuticals is conducting this
first Phase 3 trial and the long-term safety trial pursuant to a Special
Protocol Assessment (SPA) with the U.S. Food and Drug Administration.
MAP0004 is a novel, orally inhaled migraine medication in development
which has a multi-targeted mechanism of action, utilizes the company's
proprietary TEMPO(R) inhaler and is designed to optimize the key
characteristics of dihydroergotamine, an active ingredient which has been used
to effectively and safely treat migraine for over 60 years. MAP0004 has the
potential to provide a faster onset of action than currently available
migraine treatments, with sustained pain relief and pain freedom, in an easy-
to-use, non-invasive, at-home therapy. In a Phase 2 clinical trial, patients
reported pain relief in as fast as 10 minutes with sustained relief to 48
hours. The safety data generated to date have shown MAP0004 to be well
tolerated with no significant adverse events reported.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals is dedicated to developing and commercializing new
therapies for children and adults suffering from chronic conditions that are
not adequately treated by currently available medicines. The company has two
product candidates in Phase 3 clinical trials. Unit Dose Budesonide is being
developed for the potential treatment of asthma in children, and MAP0004 is
being developed for the potential treatment of migraine. 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 history.
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 MAP Pharmaceuticals' late stage clinical programs. 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 failure to obtain
clearance of the collaboration agreement with AstraZeneca under the
Hart-Scott-Rodino Act, the enrollment, conduct, completion and reporting of
clinical trials, as well as risks related to the failure to achieve favorable
clinical outcomes or to have the company's product candidates approved for
commercial use by the U.S. Food and Drug Administration. 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 November 13, 2008, and
available at http://edgar.sec.gov.
SOURCE MAP Pharmaceuticals, Inc.

Nicole Foderaro for MAP Pharmaceuticals, Inc., +1-415-215-5643