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Pearl Therapeutics Highlights Its Porous Particle Cosuspension Platform, Demonstrating Universal Applicability Across Multiple Drug Classes and Combination Products
Date:5/5/2011

REDWOOD CITY, Calif., May 5, 2011 /PRNewswire/ -- Pearl Therapeutics Inc. made three presentations at the Respiratory Drug Delivery Europe (RDD Europe 2011) meeting in Berlin this week elucidating the tunability, versatility and universality of the Company's porous particle-based metered dose inhaler (MDI) development approach.  The data provides details of Pearl's products and novel cosuspension platform, which facilitates forming stable MDI suspensions containing respiratory drugs as single components at various doses, various dual combinations, and a highly uniform triple drug combination. Further, Pearl's technology accommodates drugs of different pharmacological and chemical classes and uses conventional manufacturing processes for clinical and commercial scale production.

"Pearl scientists have developed a novel and unique cosuspension formulation approach that allows different respiratory medicines and their combinations to be formulated readily, and delivered efficiently, with the simple press-and-breathe MDI dosage form," commented Sarvajna Dwivedi, Ph.D., executive vice president and cofounder of Pearl Therapeutics. "Utilizing commercially available MDI components and manufacturing equipment, we have rapidly progressed two highly potent bronchodilators, both alone and as a dual combination product, into Phase 2b development, while successfully formulating a triple drug combination in parallel, with extensive proof of stability for each product.  Our progress and results show that the cosuspension platform has the potential of formulating drug products for improved predictability of clinical development, enhanced patient experience and compliance across therapy types, and reduced development and manufacturing costs."

In his oral presentation, Dr. Dwivedi described the physicochemical characteristics of Pearl's cosuspension platform that allows MDIs – currently used to deliver over 70% of the inhaled doses worldwide – to be developed with long-acting muscarinic antagonists (LAMA), long-acting beta-2 adrenergic receptor agonists (LABA) and inhaled corticosteroids (ICS), in their natural crystalline form.  The evidence showed that the porous particles are practically insoluble in hydrofluoroalkane (HFA) propellant, and associate with micronized drug crystals in a way that reduces the interaction between crystals and with the inhaler components.  

A supporting poster provided a comparison of dual and triple cosuspensions of the potent LAMA, glycopyrrolate with either the highly potent LABA, formoterol fumarate, or the ICS, mometasone furoate, or both formoterol fumarate and mometasone furoate.  Pearl's porous particle cosuspensions, whether formed with one, two or three of these drugs, generate highly efficient aerosols with equivalent aerodynamic particle size distribution. Moreover, they maintain long-term chemical stability within internationally accepted limits for each drug after months of storage at room temperature, confirming the continuity of product performance across various product types with Pearl's cosuspension platform over time.  

Additionally, Pearl presented evidence that the cosuspensions form quickly and can be manufactured by pressure filling into MDIs using commercially available filling equipment and standard MDI components. Various doses of single, dual and triple combination cosuspensions were produced at small scale with a process representative of commercial scale, and were found to be stable with dose-proportional and uniform aerodynamic size distribution profiles.

Dr. Dwivedi added, "The Pearl cosuspension offers consistently efficient drug delivery across drug classes, doses and product types; no detrimental physical or chemical interaction between drugs or between drugs and inhaler components over long periods of time; and manufacturability with standard components and equipment. These attributes finally position MDIs to be the simple and universal dosage form that they were designed to be when first introduced over 50 years ago."

"The Pearl cosuspension platform's predictability of drug delivery across various therapeutic classes and product types, and compatibility with conventional manufacturing equipment, should allow product development and commercial-scale production to proceed without loss of time due to complicated iterative development that has traditionally plagued inhalation product development, and without costly investment in new capital equipment or processes. We expect that this will yield significant timeline and economic advantages to Pearl, as well as to potential partners," said Chuck Bramlage, Pearl's chief executive officer.

RDD Europe is taking place from May 3 - 6, 2011 in Berlin, Germany. Information regarding RDD Europe may be found on the congress website at www.rddonline.com. Details of Pearl's presentations are below.

Presentation Date/Time: 10:30 AM, Thursday May 5, 2011
Oral Presentation Title: A New Cosuspension MDI Platform: Scientific Foundations of Mono, Dual and Triple Combination Products
Session: Science in Product Development: Advances in Processing, Formulation and Characterization (Session #3)

Presentation Date/Time:  May 4 and 5, 2011
Poster Title: Development of Mono, Dual and Triple Combination pMDIs without Co-formulation Effect

Presentation Date/Time:  May 4 and 5, 2011
Poster Title: Performance Advantages of Pearl Cosuspension Formulations Technology for Manufacturing of Metered Dose Inhalers

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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