MAP Pharmaceuticals Completes Interim Safety Review of LEVADEX(TM) Open-Label Safety Extension in More Than 400 Patients

Thu Oct 29, 2009 7:01am EDT
 
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MAP Pharmaceuticals Completes Interim Safety Review of LEVADEX(TM) Open-Label
Safety Extension in More Than 400 Patients



MOUNTAIN VIEW, Calif., Oct. 29 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals,
Inc. (Nasdaq: MAPP) today announced that it has completed a planned interim
safety review of the open-label, long-term safety extension of the company's
Phase 3 FREEDOM 301 clinical trial with its LEVADEX(TM) orally inhaled
migraine therapy. 

To date, more than 400 patients have completed at least six months of
treatment and over 7,800 headaches have been treated in the safety extension.
No drug-related serious adverse events have been reported.  

The goal of the ongoing open-label, long-term safety extension is to evaluate
overall safety, including pulmonary and cardiovascular safety, of LEVADEX in
300 patients for six months and 150 patients, including asthmatics, for 12
months as part of a potential New Drug Application.  The trial is being
conducted under a Special Protocol Assessment with the United States Food and
Drug Administration.

The interim review of the data was conducted after a pre-specified number of
patients had completed six months of exposure to LEVADEX and was also reviewed
by an independent Data Monitoring Committee (DMC). The DMC is an independent
group of clinical trial experts, including physicians, formed to critically
review and evaluate patient safety data generated in the FREEDOM 301 trial
with the objective of ensuring clinical trial patient safety, quality of the
data collected and continued scientific validity of the trial design. On an
ongoing basis, the DMC reviews data from the safety extension, including
results of both pulmonary lung function evaluations using standard measures
such as DLco and FEV1 and cardiac evaluations using EKGs, echocardiograms and
chest X-rays.  

About LEVADEX(TM)

LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3
development. Patients administer LEVADEX themselves using the company's
proprietary TEMPO inhaler. LEVADEX has been designed to be differentiated from
existing migraine treatments. It is a novel formulation of dihydroergotamine
(DHE), a drug used intravenously in clinical settings to effectively and
safely treat migraines. Based on clinical results, the company believes that
LEVADEX has the potential to provide both fast onset of action, sustained pain
relief and other migraine symptom relief in an easy-to-use and non-invasive
at-home therapy. 

LEVADEX is designed to incorporate the multiple beneficial mechanisms of
action that allow DHE to block initiation of migraine, limit pain, reduce
inflammation and stop a migraine at any point in the migraine cycle. Based on
research to date, including the efficacy portion of the FREEDOM-301 trial, the
company believes the unique pharmacokinetic profile of LEVADEX has the
potential to effectively treat migraines, while minimizing the side effects
commonly seen with DHE and other currently available medicines. 

About Migraine 

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. On average, migraine
sufferers experience 1.5 migraine attacks monthly, although 25 percent of them
experience one or more attacks weekly, according to published studies.
Migraine patients report that currently approved drugs do not fully meet their
needs due to slow onset of action, short duration of effect, inconsistent
response and unacceptable side effect profiles. 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
annually. 

About MAP Pharmaceuticals 

MAP Pharmaceuticals is dedicated to developing and commercializing new
therapies for patients suffering from conditions that are not adequately
treated by currently available medicines. The company is developing LEVADEX
inhaled therapy for the potential treatment of migraine and has reported
positive results from the efficacy portion of the first 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. 

LEVADEX and TEMPO are trademarks of MAP Pharmaceuticals, Inc. 

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' LEVADEX 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 failure to achieve favorable clinical
outcomes and to have the company's LEVADEX product candidate approved for
commercial use. 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 Annual Report on Form 10-K for the
year ended December 31, 2008, as amended, and its Quarterly Report on Form
10-Q for the quarter ended June 30, 2009, available at http://edgar.sec.gov. 


    CONTACTS:
    Lisa Borland
    MAP Pharmaceuticals, Inc.
    (650) 386-3122

    Nicole Foderaro
    Invigorate Communications
    (415) 946-1058
    nfoderaro@invigoratepr.com






SOURCE  MAP Pharmaceuticals, Inc.

Lisa Borland of MAP Pharmaceuticals, Inc., +1-650-386-3122; or Nicole Foderaro
of Invigorate Communications, +1-415-946-1058, nfoderaro@invigoratepr.com, for
MAP Pharmaceuticals, Inc.

 

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