MOUNTAIN VIEW, Calif., June 28 MAPPharmaceuticals, Inc. (Nasdaq: MAPP) today presented data from an in-vitrostudy evaluating receptor pharmacology of MAP0004, orally inhaleddihydroergotamine (DHE) for the potential treatment of migraine, compared tointravenous (IV) DHE. The study results were among six posters relating tothe MAP0004 program that the Company presented at the American HeadacheSociety 50th Annual Scientific Meeting in Boston, MA.
In this receptor pharmacology study, MAP0004 stimulated receptors thatrelieve migraine at levels comparable to IV DHE, but did not activatereceptors associated with side effects frequently seen with IV DHE. Inaddition, MAP0004 did not affect receptors that have a role in regulatingpulmonary function.
"The selective binding of MAP0004 at receptors associated with migrainerather than those associated with side effects offers a mechanistic hypothesisfor the favorable safety and efficacy profile of MAP0004 compared to IV DHEthat we have observed in our initial clinical studies," said Thomas A. Armer,Ph.D., Chief Scientific Officer of MAP Pharmaceuticals. "The absence ofnegative effects of MAP0004 on pulmonary function in asthmatic subjectsobserved in a Phase 2 study is also important because migraine and asthma arefrequently co-morbid conditions."
MAP0004 is designed to be self-administered by patients at home via MAPPharmaceuticals' proprietary Tempo(R) inhaler. In Phase 2 studies withmigraneurs and with asthmatics, treatment with MAP0004 was well-tolerated,with no serious adverse events reported. Drug-induced nausea was very low andmigraine-associated nausea also decreased with treatment.
The Company presented a poster summarizing the receptor pharmacology dataentitled "Improved Dihydroergotamine (DHE) Pharmacology FollowingOrally-Inhaled Delivery." In addition to this study, the Company presentedfive posters relating to the MAP0004 program, including:
-- Newer Acute Migraine Specific Drugs May Provide Improved SustainedRelief and Freedom Over 24 and 48 Hours Post Dosing
-- Chronic Inhalation Toxicological Assessment of Dihydroergotamine inDogs
-- Assessment of QTc Effect of DHE When Delivered Via the Lung by theTempo Inhaler
-- MAP0004, an Orally Inhaled Formulation of DHE, Delivers Faster andMore Consistent Blood Levels of the Drug Compared to Traditional Oral,Subcutaneous, Intramuscular, and Intranasal Formulations of DHE
-- Systemic Pharmacokinetics of DHE When Delivered Via the Lung toAsthmatics by the Tempo Inhaler
MAP0004 is a proprietary orally inhaled version of dihydroergotamine, orDHE, intended to treat migraine. In the Company's Phase 2 efficacy study,MAP0004 provided pain relief as early as within ten minutes of dosing, andthis relief was sustained through at least 24 hours. The study alsodemonstrated efficacy trends in treating nausea, photophobia and phonophobia.Based on these results, as well as independent research that concludes thatpatients prefer migraine therapies providing fast onset, pain relief,sustained pain relief and safety, the Company believes that MAP0004 has thepotential to be a first-line therapy for migraine patients. Historically,estimated onset of significant pain relief with oral triptans, the class ofdrugs most often prescribed for treating migraine, occurs between 45 and 90minutes after dosing. In 2007, triptans generated sales of approximately $2.2billion in the United States, according to data published by IMS Health.
MAP0004 is designed to be an easy to use, non-invasive, at-home therapythat patients self-administer using the Company's proprietary hand-held Tempoinhaler. DHE is currently available as an intravenous therapy which has beenused in clinical settings for over 50 years for the safe and effectivetreatment of migraine, but requires healthcare interve