Pearl Therapeutics' Bronchodilator Combination Therapeutic for COPD to Be Presented at the American Thoracic Society Annual Meeting

-- Four Presentations to Feature Clinical Results and Drug Delivery Characteristics of Pearl's Combination Bronchodilator, PT003, and its Components --

REDWOOD CITY, Calif., May 5 /PRNewswire/ -- Pearl Therapeutics Inc., a company developing clinically differentiated double and triple combination therapies for the treatment of highly prevalent chronic respiratory diseases, today announced four upcoming poster presentations at the Annual Meeting of the American Thoracic Society (ATS) to be held at the Ernest N. Morial Convention Center in New Orleans from May 14-19, 2010.
 

Results from Pearl's Phase 1 safety and pharmacokinetics study of PT003 will be presented at the conference. In addition, data will be presented demonstrating safety, pharmacokinetics, efficacy and drug delivery characteristics from Phase 2a trials of glycopyrrolate (PT001) and formoterol fumarate (PT005), the components of PT003, when delivered via Pearl's proprietary porous particle suspension technology. PT003 is an inhaled combination of glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol, a well-known, established, long-acting B2-agonist (LABA), delivered by metered dose inhalers (MDI), the most widely used inhalation drug delivery format. PT003 is the first and only dual long-acting rapid bronchodilator LAMA-LABA combination product in development as a pressurized hydrofluoroalkane MDI (HFA-MDI) formulation, and is currently being investigated in a Phase 2b study.
 

Information regarding the ATS presentations is below and full abstracts are now available on the ATS website at http://conference.thoracic.org/.
 

  Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm
  Poster Title: Assessment of Safety and Pharmacokinetic Profile of
   a Novel Fixed Combination of Glycopyrrolate and Formoterol HFA
   MDI in Healthy Volunteers
  Abstract Number: 5538 (Poster Board F92)
  Location: Area F, Hall G (First Level)

  Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm
  Poster Title: Glycopyrrolate and Formoterol Fumarate Monotherapy
   and Combination Metered Dose Inhalers with High Dose Uniformity
   and Stable Aerosol Properties
  Abstract Number: 5900 (Poster Board F89)
  Location: Area F, Hall G (First Level)

  Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm
  Poster Title: A Novel Formoterol Fumarate Metered Dose Inhaler
   Formulation Demonstrates Comparable Bronchodilator Efficacy
   Relative to Foradil(R) Aerolizer(R) and Favorable Safety Outcomes in
   Patients with COPD
  Abstract Number: 5114 (Poster Board F95)
  Location: Area F, Hall G (First Level)

  Presentation Date/Time: Tuesday, May 18, 2010 from 8:15am - 4:00pm
  Poster Title: A Novel Glycopyrrolate Metered Dose Inhaler
   Formulation Demonstrates Superior Bronchodilator Efficacy
   Relative to Placebo and Comparable Efficacy and Safety to
   Spiriva(R) Handihaler(R) in Patients with COPD
  Abstract Number: 5478 (Poster Board F87)
  Location: Area F, Hall G (First Level)


  About Pearl's Proprietary Porous Particle Technology and HFA-MDI Products

Pearl has overcome fundamental chemistry, manufacturing and control (CMC) issues associated with MDIs via its proprietary porous particle technology. These particles have allowed the formulation of both formoterol and glycopyrrolate in the MDI format - in combination and as monotherapies - with highly stable, robust and aerodynamically efficient drug delivery. Pearl has developed a broad portfolio of high-performance combination and monotherapy MDI products, including PT003, PT001 and PT005, utilizing this formulation platform, without the need for complex drug delivery devices or manufacturing processes.
 

Pearl also is developing 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.
 

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 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 products that focus on the development of combination products in order to optimize the treatment of COPD.
 

About Pearl Therapeutics
 

Pearl Therapeutics is developing combination therapies for the treatment of highly prevalent respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Leveraging its proprietary particle technology, formulation expertise and unparalleled product development experience, Pearl is rapidly advancing a pipeline of products that offer patients and healthcare professionals therapies that better meet their needs and improve upon the safety and efficacy of existing respiratory therapeutics. Founded in 2006, Pearl Therapeutics is privately held and backed by Clarus Ventures, New Leaf Ventures and 5AM Ventures. For more information, please visit us at http://www.pearltherapeutics.com/.
 

Spiriva® HandiHaler® (tiotropium bromide inhalation powder) is a registered trademark of Boehringer Ingelheim Pharmaceuticals; Foradil® is a registered trademark of Astellas Pharma; and Aerolizer® is a registered trademark of Novartis AG.
 

Source: Pearl Therapeutics Inc.

CONTACT: Perry Karsen, President and CEO of Pearl Therapeutics,
+1-650-305-2603, pkarsen@pearltherapeutics.com; or Aline Schimmel of WCG,
+1-312-646-6295, aschimmel@wcgworld.com
 

Web Site: http://www.pearltherapeutics.com/
 

Posted: May 2010

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