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Pearl Therapeutics Presents New Scientific Evidence Supporting Versatility of Its Novel Cosuspension MDI Platform
Date:10/28/2011

REDWOOD CITY, Calif., Oct. 28, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. presented data elucidating the robust aerosol performance and physicochemical foundations of the Company's cosuspension technology which uses spray-dried, low-density porous particles to deliver drug microcrystals via pressurized metered dose inhalers (MDIs). Two posters were presented this week at the 25th American Association of Pharmaceutical Scientists annual meeting in Washington DC.

"These results demonstrate the flexibility of Pearl's metered dose inhaler platform for multiple drugs and combinations," said Sarvajna Dwivedi, Ph.D., Pearl's cofounder and executive vice president, research and development. "The research conducted at Pearl has improved our understanding of the structure of porous particles and their constituents well beyond that of four years ago when Pearl first licensed its porous particle technology. As a result of such scientific progress, the Company has filed several new patent applications globally, which we believe will offer broad protection for our pipeline of respiratory products."

In vitro drug delivery performance data of Pearl's lead candidate for COPD, PT003, a cosuspension of formoterol fumarate (FF) and glycopyrrolate (GP), as well as a triple combination cosuspension of FF, GP and mometasone furoate (MF), an inhaled corticosteroid, were presented at the AAPS meeting, along with the results of each individual drug's cosuspension. Results demonstrate that Pearl's proprietary cosuspension technology enables consistent aerosol performance that is equivalent for all cosuspended drugs regardless of dose for mono, dual and triple combinations, without changing the nature of porous particles for each product type. Further analyses presented by Pearl scientists at AAPS show solid state structural details and thermal properties of the porous particles, which provide the Company's cosuspensions with their characteristically long room-temperature shelf life.

Pearl's president and chief executive officer, Chuck Bramlage added, "Pearl has long held a commitment not only to pipeline progression but to fundamental scientific excellence, two elements that we feel are essential when establishing a high value company. We believe these strengths will propel the current Pearl pipeline and sustain our future growth through innovation."

Poster Details
Date & Time: Wednesday, October 26, 2011; 1:00pm – 4:30pm
Location: Hall C
Title: "Thermodynamic and Structural effects of CaCl2 on the Phase Transitions and Structures of Distearoyl-Phosphatidylcholine (DSPC) by Differential Scanning Calorimetry and X-Ray Diffraction"

Date & Time: Thursday, October 27, 2011; 8:00am - 12:00pm
Location: Hall C
Title: "A New Formulation Platform for Metered Dose Inhaler Combination Products:  Cosuspensions of Engineered Phospholipid Microparticles with Micronized Actives"

Reproduction of these posters may be retrieved from the Publications page of the Pearl website.

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, 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, 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 PT001 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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