MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial For Its Pediatric Asthma Product Candidate

Main Category: Respiratory / Asthma
Also Included In: Clinical Trials / Drug Trials;  Pediatrics / Children's Health;  Pharma Industry / Biotech Industry
Article Date: 25 Mar 2008 - 0:00 PDT

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MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that in a pharmacokinetic clinical trial Unit Dose Budesonide (UDB) demonstrated lower systemic drug exposure when compared to the currently marketed conventional nebulized budesonide. UDB is MAP Pharmaceuticals' proprietary nebulized formulation of budesonide, currently in Phase 3 clinical development, for the potential treatment of pediatric asthma. UDB is designed to be administered more quickly and to provide efficacy at lower doses than conventional nebulized budesonide, which is the current leading treatment for pediatric asthma.

The clinical trial was a randomized, open label, cross-over study evaluating the pharmacokinetic profile of two doses of UDB given twice daily in 32 adults with mild to moderate asthma. A 0.135 mg dose of UDB was compared as an alternative to a 0.25 mg dose of conventional nebulized budesonide given twice daily, and a 0.25 mg dose of UDB was compared as an alternative to a 0.5 mg dose of conventional nebulized budesonide given twice daily.

In this study UDB demonstrated faster times to maximum blood concentrations as compared to conventional nebulized budesonide, and had similar maximum blood concentrations. No serious adverse events were reported in the study and nebulization time for UDB in this adult population was shorter than for the currently marketed conventional nebulized budesonide product.

"We are pleased to confirm that the UDB doses we are evaluating as part of our Phase 3 clinical program resulted in lower systemic drug exposure compared to the currently marketed conventional nebulized budesonide," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals. "These results are consistent with our previous clinical studies, and we believe provide additional support for the safety of our next generation pediatric asthma therapy."

The company plans to present the results from this study at a future scientific conference.

About Unit Dose Budesonide

MAP Pharmaceuticals is developing Unit Dose Budesonide, a novel version of nebulized budesonide for treating pediatric asthma in children from 12 months to eight years of age. Budesonide is an inhaled corticosteroid that has been used for more than 20 years with demonstrated safety and efficacy. It is the only corticosteroid approved for treating asthma in pregnant women and in children as young as 12 months old. UDB is designed to be administered more quickly and to provide efficacy at a lower corticosteroid label dose than the commercially available product.

About Pediatric Asthma

Of the estimated 20 million diagnosed asthma patients in the United States, approximately 6.8 million are children under 18 years of age and approximately 1.2 million are children under five years of age. Guidelines released in 2007 recommend the prophylactic use of inhaled corticosteroids (ICS) as the preferred initial treatment to reduce inflammation and maintain long-term control of asthma in children of all ages.

In the United States, children under the age of five typically use a nebulizer to receive inhaled corticosteroid medication because they lack the breath coordination needed to use pressurized metered-dose inhalers or they lack the lung capacity needed to use dry powder inhalers. The current goal of asthma management is, with proper treatment, to allow children with asthma to lead active lives.

Since the introduction of conventional nebulized budesonide, annual sales have grown to approximately $700 million in the United States and approximately $900 million worldwide in 2006, according to data published by IMS Health.

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.

MAP Pharmaceuticals
http://www.mappharma.com