MAP Pharmaceuticals, Inc. (MAPP) Reports Positive Results From Phase 2a Clinical Trial of Combination Therapy in Adult Asthmatics; Asthma Drug Meets Midstage Goal
MOUNTAIN VIEW, Calif., April 7, 2008 -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP - News), today announced positive results from a Phase 2a clinical study evaluating MAP0005 for the potential treatment of asthma and chronic obstructive pulmonary disease (COPD). MAP0005 is a single-particle combination of budesonide, a corticosteroid, and formoterol, a long-acting beta2-agonist, delivered to the respiratory tract using the Company's proprietary TempoÂ® inhaler.
"The results of our Phase 2a trial with MAP0005 demonstrate our ability to apply our proprietary technologies to combine two drugs within a single particle in a pre-specified ratio and deliver them to the lung," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "We believe this approach has the potential to address formulation and stability constraints often seen in the development and production of inhaled combination products. Our goal is to improve safety and efficacy by targeting consistent dose ratios and reducing systemic exposure to the beta-agonist. This approach has potential broad applicability for additional combination product candidates in a variety of indications."
This randomized, open-label, active-controlled, crossover, safety and dose response study investigated the pharmacokinetics (PK) and pharmacodynamics of MAP0005 in 15 adult asthmatics. The trial assessed the ability of MAP0005 to deliver budesonide to the lungs, as measured by PK, and formoterol to conducting airways in amounts sufficient to provide bronchodilation, both compared to the leading currently approved budesonide/formoterol combination product. The study also examined the consistency and efficiency of the Tempo inhaler in asthmatic patients.
The trial compared two different emitted doses of MAP0005, 104/5.4 mcg and 312/16.2 mcg of budesonide/formoterol with the 160/9 mcg dose of the commercially marketed combination product. Maximum change in forced expiratory volume in one second (FEV1) was similar for all three treatments, as was time to maximum change in FEV1. Plasma levels of budesonide were dose proportional for MAP0005. No serious or unexpected adverse events were reported in the study, and MAP0005 was well tolerated. The Tempo inhaler delivered budesonide more consistently than the commercially available product across the study population.
MAP0005 is a single-particle combination of budesonide, a corticosteroid, and formoterol, a long-acting beta2-agonist, delivered to the respiratory tract using MAP Pharmaceuticals' proprietary Tempo inhaler. MAP0005 uses the Company's proprietary particle technology to combine the corticosteroid and beta-agonist components into a single drug particle in a fixed, pre-specified ratio. MAP Pharmaceuticals believes this combination technology has the potential to overcome formulation and stability constraints often seen in the development and production of inhaled combination products. In addition, the Company's technology allows particles to be specifically designed to target relevant areas in the lung and to release drug at a desired rate. While MAP Pharmaceuticals does not plan to make further significant direct investment in this product candidate, it plans to evaluate partnership opportunities for further development and commercialization of MAP0005 as well as other product candidates which may utilize this technology.
About the Tempo Inhaler
MAP Pharmaceuticals is developing the Tempo inhaler, a novel pressurized metered dose inhaler that synchronizes the discharge of drug with the patient's breathing cycle, which can be optimized for each therapy based on desired delivery. It is designed to dispense drug in an efficient and consistent manner to minimize dose-to-dose differences in and between patients. The inhaler is convenient and easy to use, and contains a dose counter that can lock out after a maximum number of doses.
About Asthma and COPD
Asthma is a chronic respiratory disorder that is characterized by inflammation and narrowing of the airways, leading to limitation or obstruction of airflow and resulting in symptoms such as episodes of wheezing, chest tightness, breathlessness and coughing. Asthma is a variable condition that can change both daily and seasonally. The Centers for Disease Control estimates there are 23 million Americans diagnosed with asthma. Despite a variety of treatments available in the United States, asthma is still poorly controlled and many patients require daily maintenance treatment with combination therapy.
Chronic obstructive pulmonary disease refers to several diseases, including chronic bronchitis and emphysema, which cause airflow obstruction and interfere with normal breathing. According to the National Heart Lung and Blood Institute, more than 12 million people in the United States have been diagnosed with COPD and another 12 million likely have the illness but do not know it. COPD is one of the leading causes of death and disability in the United States and is caused in many cases by heavy cigarette smoking in earlier life.
According to Datamonitor, a leading market research company, the potential market for asthma and COPD was estimated at approximately $19 billion in 2006, with expected growth to approximately $30 billion by 2015.
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.
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to the further development of MAP0005 and the potential application of MAP Pharmaceuticals' technologies to additional product candidates. 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 development and commercialization of product candidates incorporating MAP Pharmaceuticals' technologies. 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 Annual Report on Form 10K, filed with the SEC on March 20, 2008, available at http://edgar.sec.gov.