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Pearl Therapeutics Phase 2b Twice-Daily Dosing Data Suggest Morning and Evening Benefit of PT003 in Patients with COPD
Date:5/14/2012

REDWOOD CITY, Calif., May 14, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. announced plans to make 11 presentations at upcoming medical meetings to report clinical and product development information pertaining to PT003 (GFF MDI), a proprietary, fixed-dose combination of glycopyrrolate (GP), a long-acting muscarinic antagonist (LAMA) and formoterol fumarate (FF), a long-acting beta-2 agonist (LABA). PT003 and its components, PT001 (GP MDI) and PT005 (FF MDI) are being developed for the treatment of patients with moderate-to-severe COPD. Among these presentations will be previously undisclosed results of a Phase 2b study in which PT003 was shown to be associated with a significant improvement in home peak expiratory flow rate (PEFR), a measure of lung function, when compared to placebo, individual components of PT003, and open-label active controls (p < 0.03 for all comparisons). Importantly, this improvement was observed for both morning and evening PEFR assessments, which may suggest a morning and evening bronchodilator effect with twice-daily administration of PT003. In addition to improvement in home PEFR, Phase 2b results being presented at ATS demonstrate that PT003 is associated with a reduction in rescue albuterol use compared to placebo and controls. The product development data being presented at the RDD meeting demonstrate Pearl's ongoing commitment to designing PT003 and its component inhalers for reliable drug delivery that will be further evaluated in late-stage clinical development.

"At ATS this year, we are presenting a compendium of Phase 2b clinical findings that provide further support for PT003 as a potential treatment for patients with moderate-to-severe COPD," stated Dr. Colin Reisner, chief medical officer and executive vice president of clinical development for Pearl Therapeutics. "It is well documented that patients with COPD experience worsening of their symptoms in the morning and evening. The significant improvement with twice-daily administration of PT003 vs placebo in home PEFR in both the morning and the evening pre- and post-dose assessments suggest that PT003 may provide benefit at the times when patients' symptoms are known to worsen. The potential benefits of this dual-peak effect following morning and evening dosing will be evaluated further in late-stage studies."

Clinical results are also being presented supporting the selection of the FF MDI (PT005) dose to be tested in the Company's Phase 3 fixed-dose combination studies of PT003. CMC data on Pearl's "triple" combination of GP, FF and an inhaled corticosteroid (ICS) is described in another Pearl presentation at ATS, and a late-breaking presentation on the formulation of MDIs that deliver nanogram-level doses of GP and FF will also be presented.

Chuck Bramlage, Pearl's chief executive officer, added, "We believe the depth and strength of the clinical data, and the achievements by Pearl scientists in designing robust and reproducible inhalers, substantially de-risk the Pearl bronchodilator family of products for late-stage development. We also believe that the innovations Pearl has made in respiratory drug delivery truly differentiate PT003 development from conventional inhaled product development, and set a new benchmark in capital and time efficiency in the field of pulmonary product development. We look forward to concluding the Phase 2b program in 2012 and commencing with a plan to support registration of PT003 thereafter."

Of the 11 presentations, three presentations will be made at the Respiratory Drug Delivery (RDD) meeting taking place May 13-17 in Phoenix, AZ, and eight at the American Thoracic Society (ATS) meeting taking place May 18-23 in San Francisco, CA. Additional information regarding the ATS and RDD meetings may be found at http://conference.thoracic.org and http://www.rddonline.com, respectively. A complete list of Pearl's presentations at these and earlier meetings may be found on their website at http://www.pearltherapeutics.com/publications.

For ATS attendees, additional information may also be found at Pearl Therapeutics Booth G, located in the Research & Science Exchange. This is a new area set aside from the main exhibition hall for organizations to discuss clinical trials in progress and scientific achievements in a non-commercial environment.

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 effects compared to increasing the dose of a single bronchodilator. As the course of COPD progresses, regular treatment with inhaled glucocorticosteroids may be added to bronchodilator treatment. Pearl is developing inhaled combination products designed to optimize the treatment of COPD.

About Pearl Therapeutics
Pearl Therapeutics is a privately held company developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease and asthma. Pearl is rapidly advancing a pipeline of products including PT003 (GFF MDI), an inhaled, fixed-dose combination bronchodilator product comprised of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) delivered via a metered dose inhaler (HFA MDI); and PT010 (GMFF MDI), a triple-combination product that combines the LAMA and LABA components of PT003 with an inhaled corticosteroid (ICS) for twice-daily administration from an HFA MDI for the treatment of severe COPD. Both PT003 and PT010 are developed with Pearl's proprietary porous particle cosuspension technology, which allows the formulation of multiple products in the MDI format, with highly stable, robust and aerodynamically efficient drug delivery. Founded in 2006, Pearl Therapeutics is privately held and backed by 5AM Ventures, Clarus Ventures, New Leaf Ventures and Vatera Healthcare. For more information, please visit www.pearltherapeutics.com.


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