MOUNTAIN VIEW, Calif., Jan. 12 MAPPharmaceuticals, Inc. (Nasdaq: MAPP) today announced continued progress withits two Phase 3 clinical programs, Unit Dose Budesonide (UDB) for childrenwith asthma and MAP0004 for the acute treatment of migraine. For UDB, allpatients have completed the 12 week treatment period in the initial Phase 3clinical trial, and for MAP0004, the company currently expects to completeenrollment 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 migraineprograms and look forward to reporting data from both programs during thefirst half of 2009," said Timothy S. Nelson, President and CEO of MAPPharmaceuticals. "We believe this clinical progress coupled with our recentlyannounced asthma partnership with AstraZeneca highlights the value of ourclinical approach and business strategy."
UDB Phase 3 Program
The initial UDB Phase 3 clinical trial completed enrollment in September2008, and all patients now have completed the treatment period. This Phase 3trial is a multi-center, randomized, double-blind, placebo controlled trial inapproximately 360 children who suffer from asthma, from 12 months to 8 yearsof age. Patients received either 0.25mg UDB, 0.135mg UDB or placebo twice aday over a 12 week treatment period. The co-primary efficacy endpoints forthe study are the change in nighttime and daytime composite symptom scores(cough, wheeze and breathlessness). Patients enrolled in this trial willcontinue 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 tobe nebulized more quickly and at a lower nominal dose than the commerciallyavailable product. The safety data generated to date has shown UDB to be welltolerated with no significant adverse events reported.
MAP0004 Phase 3 Program
MAP Pharmaceuticals expects to complete enrollment in its initial Phase 3clinical trial for the acute treatment of migraine by the end of January 2009.The Phase 3 multi-center, randomized, double-blind, placebo controlled trialin approximately 850 migraine sufferers is evaluating MAP0004 as a potentialacute treatment for migraine. Patients enrolled in the trial will beevaluated for the treatment of a single migraine and will continue to befollowed in a long-term safety trial. MAP Pharmaceuticals is conducting thisfirst Phase 3 trial and the long-term safety trial pursuant to a SpecialProtocol Assessment (SPA) with the U.S. Food and Drug Administration.
MAP0004 is a novel, orally inhaled migraine medication in developmentwhich has a multi-targeted mechanism of action, utilizes the company'sproprietary TEMPO(R) inhaler and is designed to optimize the keycharacteristics of dihydroergotamine, an active ingredient which has been usedto effectively and safely treat migraine for over 60 years. MAP0004 has thepotential to provide a faster onset of action than currently availablemigraine treatments, with sustained pain relief and pain freedom, in an easy-to-use, non-invasive, at-home therapy. In a Phase 2 clinical trial, patientsreported pain relief in as fast as 10 minutes with sustained relief to 48hours. The safety data generated to date have shown MAP0004 to be welltolerated with no significant adverse events reported.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals is dedicated to developing and commercializing newtherapies for children and adults suffering from chronic conditions that arenot adequately treated by currently available medicines. The company has twoproduct candidates in Phase 3 clinical trials. Unit Dose Budesonide is beingdeveloped for the potential treatment of asthma in children, and MAP0004 isbeing developed for the potential treatment of migraine. MAP Pharmaceuticalsgenerates new pipeline opportunities by applying its proprietary drug particleand inhalation technologies to enhance the therapeutic benefits of provendrugs, while minimizing risk, by capitalizing on their known safety, efficacyand history.
Forward Looking Statements
In addition to statements of historical facts or statements of currentconditions, this press release contains forward-looking statements, includingwith respect to MAP Pharmaceuticals' late stage clinical programs. Actualresults may differ materially from current expectations based on risks anduncertainties affecting MAP Pharmaceuticals' business, including, withoutlimitation, risks and uncertainties relating to the failure to obtainclearance of the collaboration agreement with AstraZeneca under theHart-Scott-Rodino Act, the enrollment, conduct, completion and reporting ofclinical trials, as well as risks related to the failure to achieve favorableclinical outcomes or to have the company's product candidates approved forcommercial use by the U.S. Food and Drug Administration. The reader iscautioned not to unduly rely on the forward-looking statements contained inthis press release. MAP Pharmaceuticals expressly disclaims any intent orobligation to update these forward-looking statements, except as required bylaw. Additional information on potential factors that could affect MAPPharmaceuticals results and other risks and uncertainties are detailed in itsQuarterly Report on Form 10-Q, filed with the SEC on November 13, 2008, andavailable at http://edgar.sec.gov.
SOURCE MAP Pharmaceuticals, Inc.