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Pearl Therapeutics Announces Successful Completion of Phase 2b Safety and Efficacy Studies of COPD Combination, PT003
Date:1/6/2012

study of PT003 compared with its components and marketed bronchodilators, Foradil® Aerolizer® and Spiriva® HandiHaler®. Approximately 700 patients with moderate-to-severe COPD have taken part in Pearl's Phase 2b clinical program to date.

"The totality of findings from our clinical program to date, which includes five Phase 2b studies, two Phase 1/2a studies and one Phase 1 study, present a strong foundation on which we plan to build a comprehensive Phase 3 program to support regulatory approval of PT003," added Dr. Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "I believe the world-class team of pulmonary drug development specialists that we have assembled, and our proven ability to conduct well-controlled and highly informative trials will provide the regulatory support needed to make our bronchodilator product family available for the very large patient population which suffers from the debilitating effects of COPD."

About COPD

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable lung disease that is the fourth leading cause of death in the United States. Each year 12 million Americans are diagnosed with COPD and an additional 12 million Americans may have COPD but remain undiagnosed. Research shows that many do not get optimal treatment.

Bronchodilator medications are central to symptom management and are prescribed on an as-needed or regular basis to prevent or reduce symptoms. Long-acting inhaled bronchodilators have been shown to be most effective and convenient. Combining bronchodilators of different pharmacological classes, as recommended by The Global Initiative for Chronic Obstructive Lung Diseases (GOLD), has been shown to improve efficacy and may decrease the risk of side effec
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SOURCE Pearl Therapeutics
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2. Pearl Therapeutics to Present Complete PT003 Results from Phase 2b COPD Study in a Late-Breaker Session at the American Thoracic Society Annual Meeting
3. Pearl Therapeutics Highlights Its Porous Particle Cosuspension Platform, Demonstrating Universal Applicability Across Multiple Drug Classes and Combination Products
4. Asante Solutions Receives FDA Clearance for Pearl™ Insulin Pump
5. Pearl Therapeutics Phase 2b Results Show a 50% Improvement in Lung Function with PT003 Compared to Spiriva® and Foradil® in Patients with COPD
6. Pearl Therapeutics Advances Its Long-Acting Bronchodilator Combination Product Candidate into Four Additional Phase 2 Studies
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8. Pearl Therapeutics Bronchodilator Combination PT003 Provides Superior Inspiratory Capacity Compared to Spiriva®
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10. Pearl Therapeutics Presents New Scientific Evidence Supporting Versatility of Its Novel Cosuspension MDI Platform
11. Pearl Therapeutics Reports Positive Phase 2b Results of PT001 in Patients With COPD
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