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MAP Pharmaceuticals Reaches Agreement with FDA on Special Protocol Assessment for MAP0004 Phase 3 Clinical Trial in Patients With Migraine
Date:1/16/2008

FDA evaluates clinical protocols and may achieve agreement with sponsors and applicants on the design and size of the studies and clinical trials that can be used for approval of a drug. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application. In general, these assessments are considered binding on the FDA as well as the sponsor unless public health concerns unrecognized at the time the SPA is entered into become evident or other new scientific concerns regarding product safety or efficacy arise.

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: UDB, a proprietary version of nebulized budesonide for the potential treatment of children with asthma, and MAP0004, a proprietary version of orally inhaled dihydroergotamine delivered by MAP Pharmaceuticals' proprietary Tempo inhaler for the potential treatment of migraine. In addition to UDB and MAP0004, MAP Pharmaceuticals has other proprietary product candidates in clinical development that also address large market opportunities, including a proprietary combination of an inhaled corticosteroid with 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

SOURCE MAP Pharmaceuticals, Inc.
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