MOUNTAIN VIEW, Calif., June 28 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. today presented data from an in-vitro study evaluating receptor pharmacology of MAP0004, orally inhaled dihydroergotamine (DHE) for the potential treatment of migraine, compared to intravenous (IV) DHE. The study results were among six posters relating to the MAP0004 program that the Company presented at the American Headache Society 50th Annual Scientific Meeting in Boston, MA.
In this receptor pharmacology study, MAP0004 stimulated receptors that relieve migraine at levels comparable to IV DHE, but did not activate receptors associated with side effects frequently seen with IV DHE. In addition, MAP0004 did not affect receptors that have a role in regulating pulmonary function.
"The selective binding of MAP0004 at receptors associated with migraine rather than those associated with side effects offers a mechanistic hypothesis for the favorable safety and efficacy profile of MAP0004 compared to IV DHE that we have observed in our initial clinical studies," said Thomas A. Armer, Ph.D., Chief Scientific Officer of MAP Pharmaceuticals. "The absence of negative effects of MAP0004 on pulmonary function in asthmatic subjects observed in a Phase 2 study is also important because migraine and asthma are frequently co-morbid conditions."
MAP0004 is designed to be self-administered by patients at home via MAP Pharmaceuticals' proprietary Tempo(R) inhaler. In Phase 2 studies with migraneurs and with asthmatics, treatment with MAP0004 was well-tolerated, with no serious adverse events reported. Drug-induced nausea was very low and migraine-associated nausea also decreased with treatment.
The Company presented a poster summarizing the receptor pharmacology data entitled "Improved Dihydroergotamine (DHE) Pharmacology Following Orally-Inhaled Delivery." In addition to this study, the Company presented five posters relating to the MAP0004 program, including:
-- Newer Acute Migraine Specific Drugs May Provide Improved Sustained Relief and Freedom Over 24 and 48 Hours Post Dosing
-- Chronic Inhalation Toxicological Assessment of Dihydroergotamine in Dogs
-- Assessment of QTc Effect of DHE When Delivered Via the Lung by the Tempo Inhaler
-- MAP0004, an Orally Inhaled Formulation of DHE, Delivers Faster and More 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 to Asthmatics by the Tempo Inhaler
About MAP0004
MAP0004 is a proprietary orally inhaled version of dihydroergotamine, or DHE, intended to treat migraine. In the Company's Phase 2 efficacy study, MAP0004 provided pain relief as early as within ten minutes of dosing, and this relief was sustained through at least 24 hours. The study also demonstrated efficacy trends in treating nausea, photophobia and phonophobia. Based on these results, as well as independent research that concludes that patients prefer migraine therapies providing fast onset, pain relief, sustained pain relief and safety, the Company believes that MAP0004 has the potential to be a first-line therapy for migraine patients. Historically, estimated onset of significant pain relief with oral triptans, the class of drugs most often prescribed for treating migraine, occurs between 45 and 90 minutes after dosing. In 2007, triptans generated sales of approximately $2.2 billion in the United States, according to data published by IMS Health.
MAP0004 is designed to be an easy to use, non-invasive, at-home therapy that patients self-administer using the Company's proprietary hand-held Tempo inhaler. DHE is currently available as an intravenous therapy which has been used in clinical settings for over 50 years for the safe and effective treatment of migraine, but requires healthcare intervention for administration. In the Company's Phase 2 clinical efficacy study, MAP0004 was shown to retain the rapid onset and long-lasting effectiveness of intravenous DHE while avoiding the nausea that intravenous administration can cause.
About Migraine
Migraine is a common, debilitating neurological disease affecting approximately 30 million people in the United States. It presents with recurrent attacks of headaches, nausea, vomiting and sensitivity to light and sound. 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% of them experience one or more attacks weekly. Currently approved drugs for the treatment of an acute migraine attack do not fully meet the needs of all patients due to the slow onset of action, short duration of effect, inconsistent response, unacceptable side effect profiles, or propensity to increase frequency of headaches with these therapies.
About MAP Pharmaceuticals, Inc.
MAP Pharmaceuticals develops and plans to commercialize new therapies for children and adults who suffer from chronic conditions that it believes are not adequately treated by currently available medicines. The Company applies its 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. MAP Pharmaceuticals has two drug candidates, Unit Dose Budesonide and MAP0004, in late stage development for the potential treatment of pediatric asthma and migraine respectively. MAP Pharmaceuticals' pipeline also includes a drug candidate in early clinical development for the 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 our MAP0004 migraine program. Actual results may differ materially from current expectations based on risks and uncertainties affecting MAP Pharmaceuticals' business, including, without limitation, risks and uncertainties relating to the development, clinical testing and potential commercialization of our product candidates. 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 May 14, 2008, and available at http://edgar.sec.gov/.
