September 18, 2014 10:41 PM ET

Pharmaceuticals

Company Overview of Pearl Therapeutics Inc.

Company Overview

Pearl Therapeutics Inc. develops dual and triple combination products for the treatment of respiratory diseases, including chronic obstructive pulmonary disease worldwide. The company focuses on therapies for the treatment of asthma and rhinosinusitis. Its products include a fixed-dose combination bronchodilator; PT003 (glycopyrronium and formoterol fumarate); monotherapy components; PT001 (glycopyrronium); and PT005 (formoterol fumarate) for the treatment of chronic obstructive pulmonary disease. The company was founded in 2006 and is based in Redwood City, California. As of June 27, 2013, Pearl Therapeutics Inc. operates as a subsidiary of AstraZeneca PLC.

200 Saginaw Drive

Redwood City, CA 94063

United States

Founded in 2006

Phone:

650-305-2600

Fax:

650-568-1804

Key Executives for Pearl Therapeutics Inc.

Chief Executive Officer
Age: 53
Executive Chairman
Age: 69
Co-Founder and Chief Scientific Officer
Vice President of Finance and Administration
Chief Executive Officer of Vatera Holdings LLC and Chief Investment Officer of Vatera Holdings LLC
Age: 43
Compensation as of Fiscal Year 2014.

Pearl Therapeutics Inc. Key Developments

Pearl Therapeutics Inc. Initiates PT003 Phase 3 Program for the Treatment of Individuals with Moderate-to-Severe COPD

Pearl Therapeutics Inc. announced the initiation of PINNACLE, a global Phase 3 program of PT003, the company's fixed-dose combination of glycopyrrolate, a long-acting muscarinic antagonist and formoterol fumarate, a long-acting beta-2 agonist (LABA), delivered via a pressurized hydrofluoroalkane (HFA MDI) using the Company's novel co-suspension formulation platform. PINNACLE will assess the improvement in lung function generated by PT003 in individuals with moderate-to-severe COPD. Following the successful completion of this Phase 3 program, Pearl expects to file its US regulatory application in mid 2015, followed later by filings in the EU and Canada. COPD remains a significant and poorly addressed medical condition. The PINNACLE program will enroll over 2,700 individuals throughout the US, Canada, Europe, Australia and New Zealand at over 260 study sites. In both studies, the efficacy of a single dose of PT003 will be compared to that of its components, PT001 and PT005, and placebo. In one of the two trials, open label tiotropium will serve as active control. Participants in both efficacy studies will have the option of continuing treatment with PT003 in a 28-week extension study, which will serve as an additional assessment of long-term safety. The primary efficacy endpoint will be improvement in lung function as assessed by forced expiratory volume in one second (FEV1); additional co-primary endpoints will also be assessed to support regulatory requirements in certain regions. The Company anticipates that enrollment will conclude in mid 2014.

Pearl Therapeutics Inc. Presents at 12th Annual Needham Healthcare Conference, May-01-2013 09:00 AM

Pearl Therapeutics Inc. Presents at 12th Annual Needham Healthcare Conference, May-01-2013 09:00 AM. Venue: The Westin Grand Central Hotel, 212 East 42nd Street, New York, New York, United States.

Pearl Therapeutics Inc. Presents at Citi 2013 Global Healthcare Conference, Feb-27-2013 01:30 PM

Pearl Therapeutics Inc. Presents at Citi 2013 Global Healthcare Conference, Feb-27-2013 01:30 PM. Venue: Hilton New York, 1335 Avenue of the Americas, New York, NY 10019, United States.

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