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MAP Pharmaceuticals to Present Data Showing Low Migraine Recurrence Rates With LEVADEX™ in FREEDOM-301 Trial
Date:10/29/2010

MOUNTAIN VIEW, Calif., Oct. 29 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced new data from the FREEDOM-301 Phase 3 trial of its investigational LEVADEX™ orally inhaled migraine therapy showing low recurrence rates with LEVADEX. Eight additional analyses from the LEVADEX program also will be presented during the 2010 European Headache and Migraine Trust International Congress (EHMTIC) in Nice, France.  

Physicians commonly use the term recurrence to assess the sustained action of a migraine drug. However, there is not a standard definition of recurrence, and different methods are used in the clinical setting to calculate recurrence rates. This analysis calculated recurrence rates using four different definitions from the literature to illustrate the variability of using this endpoint for comparing different migraine treatments.

"Recurrence rate is one of the main attributes that physicians rely on to assess the sustained effects of acute migraine therapies.  However, the way in which recurrence is defined can vary widely," said Shashidhar H. Kori, M.D., Vice President, Clinical Development and Medical Affairs of MAP Pharmaceuticals. "While a standard definition would help make these comparisons more meaningful, data from this analysis showed low recurrence rates with LEVADEX regardless of the definition used."

In the poster titled "Migraine Recurrence Rates: Case for Standardization of the Definition," LEVADEX had a low recurrence rate at both 24 and 48 hours irrespective of the definition used. Two large meta-analyses have calculated the cumulative recurrence rate for triptans to be 22 percent and 29 percent over 24 hours. Using the same definition, this analysis found LEVADEX to have a recurrence rate of 6.5 percent over 24 hours and 10.3 percent over 48 hours. No 48 hour recurrence data was reported in the triptan analyses. Factors found to affect the rate of recurrence in the triptan meta-analyses include gender of the patient, age group (below 35 and above 35), and severity of headache pain at the time of treatment (moderate vs. severe). In this analysis, both age and severity of pain at time of treatment were associated with higher recurrence rates in the placebo group.

A second new analysis, "The Major Metabolite of Dihydroergotamine (DHE) After Oral Inhalation and IV Administration Does Not Significantly Contribute to the Pharmacological Activity," analyzed results of two studies and showed that the pharmacologic contribution of DHE's primary metabolite is minimal.

The seven other analyses to be presented include:

  • LEVADEX, a Novel Orally Inhaled Treatment for Acute Migraine: Efficacy and Tolerability Results of a Phase 3 Study (#462)
  • Efficacy Evaluation of LEVADEX in Treating a Broad Spectrum of Acute Migraine Attacks (#463)
  • Efficacy Evaluation of LEVADEX in Treating Resistant Migraine Including Migraine with Allodynia, Morning Migraine, Disabling Migraine and Migraine Treated Late (#464)
  • Utility of LEVADEX in Situations Where Early Intervention Paradigm is Impractical (#322)
  • Evaluation of Safety and Efficacy of LEVADEX (MAP0004) in Treating Acute Menstrual Migraine (#465)
  • Evaluation of Efficacy and Safety of LEVADEX (MAP0004) in Reversing Central Sensitization and Treating Migraine in Established Allodynic Patients (#466)
  • The Efficacy and Tolerability of LEVADEX (Orally Inhaled DHE) for the Treatment of Migraine in Subjects with Concomitant Asthma (#467)

  • About LEVADEX™ 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 its 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.

    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 conduct and completion of clinical trials, and relating to the preparation and filing of a New Drug Application and the regulatory process 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, available at http://edgar.sec.gov. CONTACTS:Nicole FoderaroWCG(415) 946-1058nfoderaro@wcgworld.com
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    SOURCE MAP Pharmaceuticals, Inc.
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