MOUNTAIN VIEW, Calif., July 16 CA-MAP-Pharmaceutic
MOUNTAIN VIEW, Calif., July 16 /PRNewswire-FirstCall/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the positive results from
a Phase 2 study evaluating the safety, tolerability and pharmacokinetics of
MAP0004 in adult asthmatics were published in the July issue of Current
Medical Research and Opinion. MAP Pharmaceuticals is developing MAP0004, an
orally inhaled and self-administered therapy, as a potential treatment for
migraine.
The study results, which were first announced last year, demonstrated that
treatment with MAP0004 resulted in rapid and efficient systemic absorption of
the therapeutic compound, dihydroergotamine (DHE), in asthmatic subjects, and
that absorption was comparable to that observed in a previous study of healthy
volunteers.
"Asthma and migraine have a high incidence of co-morbidity, so it was
important to evaluate MAP0004 in patients with compromised pulmonary
function," said Thomas A. Armer, Ph.D., chief scientific officer of MAP
Pharmaceuticals. "In the study, MAP0004 was well tolerated by asthmatics with
no effect on pulmonary function and with no serious adverse events reported."
About the Phase 2 Study
The Phase 2 study was a randomized, double-blind, placebo-controlled,
crossover study of MAP0004 in 19 adult asthmatics. Each patient received three
doses, one every week in randomized order over a 15-day period, including two
1.0 mg doses of MAP0004 and one dose of placebo. The 1.0 mg dose is twice the
dose being studied in MAP Pharmaceuticals' Phase 3 trial. Spirometry was
performed and blood draws were obtained at screening and at multiple times
during each visit.
The study indicated that MAP0004 was well tolerated by subjects with
compromised lung function, and that the pharmacokinetics of MAP0004 was
similar to that experienced by adults with healthy lungs as shown in an
earlier Phase 1 study. No serious adverse events were reported. In addition,
no clinically significant changes were observed in pulmonary function tests or
mean IgE levels, a measure of systemic immune response.
About MAP0004
In another Phase 2 efficacy study presented last year, MAP0004 provided
pain relief in as fast as ten 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.
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.
MAP0004 is orally inhaled and self administered at home using the
company's proprietary Tempo(R) inhaler, a novel pressurized metered dose
inhaler that synchronizes the discharge of drug with the patient's breathing
cycle. The Tempo inhaler can be optimized for each therapy based on desired
delivery, and is designed to dispense drug in an efficient and consistent
manner to minimize dose-to-dose differences in and between patients. The
inhaler is convenient and easy to use, and contains a dose counter that can
lock out after a maximum number of doses.
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 our 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. 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.
