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MAP
Pharmaceuticals Initiates Phase 3 Clinical Trial of Unit
Dose Budesonide in Children with Asthma
MOUNTAIN VIEW, Calif., Jan. 7 /PRNewswire-FirstCall/ --
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP), an emerging
pharmaceutical company, today announced it has initiated
a Phase 3 clinical trial evaluating Unit Dose Budesonide
(UDB), the company's proprietary nebulized version of
budesonide, for the potential treatment of pediatric
asthma.
UDB is an inhaled corticosteroid that is designed to be
administered more quickly and to provide efficacy at
lower doses than conventional nebulized budesonide and
thus may offer improved safety, convenience and
compliance for young patients who suffer from asthma.
The Phase 3 clinical trial is a multi-center,
randomized, double-blind, placebo controlled study in
approximately 360 asthmatic children, 12 months to eight
years of age. Patients are randomized to either 0.25mg
UDB, 0.135mg UDB or placebo given twice a day over a
12-week treatment period. The primary efficacy endpoint
for the study is the change in nighttime and daytime
composite symptom scores (cough, wheeze and
breathlessness).
"Unit Dose Budesonide is one of MAP Pharmaceuticals' two
most advanced product candidates, and we are excited to
announce the initiation of this Phase 3 clinical trial,"
said Timothy S. Nelson, President and Chief Executive
Officer of MAP Pharmaceuticals. "We look forward to
working with our investigators to continue to study the
safety and efficacy of UDB and to support our goal of
developing a convenient low dose therapy for the
treatment of asthma in young children."
About Unit Dose Budesonide
MAP Pharmaceuticals is developing Unit Dose Budesonide,
a novel version of nebulized budesonide for treating
pediatric asthma in children from 12 months to eight
years of age. Budesonide is an inhaled corticosteroid
that has been used for more than 20 years with
demonstrated safety and efficacy. It is the only
corticosteroid approved for treating asthma in pregnant
women and in children as young as 12 months old. UDB is
designed to be administered more quickly and to provide
efficacy at a lower corticosteroid label dose than the
commercially available product.
About Pediatric Asthma
Of the estimated 20 million diagnosed asthma patients in
the United States, approximately 6.5 million are
children under 18 years of age and approximately 1.4
million are children under five years of age. Guidelines
released in 2007 recommend the prophylactic use of
inhaled corticosteroids (ICS) as the preferred treatment
to reduce inflammation and maintain long-term control of
asthma in children aged five years and younger.
In the United States, children under the age of five
typically use a nebulizer to receive inhaled
corticosteroid medication because they lack the breath
coordination needed to use pressurized metered-dose
inhalers or they lack the lung capacity needed to use
dry powder inhalers. The current goal of asthma
management is, with proper treatment, to allow children
with asthma to lead active lives.
Since the introduction of conventional nebulized
budesonide, annual sales have grown to approximately
$700 million in the United States and approximately $900
million worldwide in 2006, according to data published
by IMS Health.
About MAP Pharmaceuticals,
Inc.
MAP Pharmaceuticals develops and plans to commercialize
new therapies for children and adults who suffer from
diseases that the company believes are not treated
adequately by currently available medicines. The company
uses 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. The company has several proprietary product
candidates in clinical development that address large
market opportunities, including its two most advanced
product candidates: a proprietary version of nebulized
budesonide for the potential treatment of children with
asthma (UDB), and a proprietary version of orally
inhaled dihydroergotamine delivered by MAP
Pharmaceuticals' proprietary Tempo(TM) inhaler for the
potential treatment of migraine (MAP0004). In addition
to UDB and MAP0004, MAP Pharmaceuticals has several
other proprietary product candidates in clinical
development that also address large market
opportunities, including a proprietary combination of an
inhaled corticosteroid and a long-acting beta2-agonist
for the potential 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 development, therapeutic potential and
safety of the company's UDB product candidate. 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 the enrollment and conduct of
clinical trials, as well as risks relating to failure to
achieve favorable clinical outcomes and that UDB will
not be approved for commercial use by the United States
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 19,
2007, and available at http://edgar.sec.gov.
For More Information,
Contact:
Lisa Johnson of MAP Pharmaceuticals, Inc.
+1-650-386-3122
ljohnson@mappharma.com
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