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Pharmaxis Ltd (PXS.AX) Launches ARIDOL(R) (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness


2/24/2011 8:22:15 AM

EXTON, Pa., Feb. 23, 2011 /PRNewswire/ -- Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today the commercial launch of ARIDOL® (mannitol inhalation powder)Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades and the company's first product launch in the U.S. ARIDOL is used to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. ARIDOL should not be used as a stand alone test to assess asthma or as a screening test for asthma, but as part of a physician's overall assessment of asthma. ARIDOL can be ordered directly from Pharmaxis and is available to pulmonary function labs and physicians' offices by calling Pharmaxis Customer Service at 1-888-416-1828.

"ARIDOL is an important advancement in bronchial challenge testing the first in 20 years and a significant addition to the tools available to help in an overall assessment of asthma," said Stephen Beckman, President, Pharmaxis, Inc. "We are excited to provide patients and the medical community with an effective, accurate and reproducible test that can be conducted in the convenience of a pulmonary function lab or physician's office."

ARIDOL is a single-use, indirect test that is easy-to-administer, requires minimal preparation time and a 15% reduction in lung function from baseline for a positive test. ARIDOL was approved by the U.S. Food and Drug Administration (FDA) on October 5, 2010, and demonstrated safety and efficacy in two Phase III clinical trials.

"The ARIDOL Bronchial Challenge Test takes only about 20 minutes to administer for a positive test and requires a 15% reduction in FEV[1]. Previous options may take up to 40 minutes to implement and require a 20% reduction in FEV[1]," said Bradley Chipps, MD, Capital Allergy and Respiratory Disease Center, Sacramento, CA. "The ARIDOL Bronchial Challenge Test offers health care professionals another tool to help with a disease that is often hard to definitively diagnose."

"PHARMAXIS is committed to bringing our therapeutic advances for respiratory and immune diseases to patients throughout the world. The U.S. launch of ARIDOL highlights this commitment and our focus on helping physicians and patients world-wide affected by respiratory illnesses," added Mr. Beckman.

How ARIDOL Works

The ARIDOL test requires patients to inhale increasing doses of dry powder mannitol from a simple, hand-held device, which causes airways to narrow and contract when airway inflammation is present. The doses are contained in capsules that are administered at one-minute intervals until a positive response is achieved or until all the capsules have been inhaled, indicating a negative result. A positive response is indicated when there is a 15% reduction in lung function from baseline compared to a 20% fall required by a methacholine challenge test.(1) The lower the dose required to cause bronchoconstriction, the more severe the bronchial hyperresponsiveness.

Other Bronchial Challenge Tests

Unlike other bronchial challenge tests, ARIDOL is a single-use test that requires less preparation time and eliminates reconstitution, use of a nebulizer to administer, clean-up and sterilization. A positive ARIDOL test is complete in approximately 20 minutes, compared to an average of 45 minutes for a methacholine test.(2) A methacholine test requires additional equipment to administer and a designated testing room with ventilation.(1) Tests that use exercise to assess bronchial hyperreponsiveness require special equipment and conditions, and may not be appropriate for patients with physical limitations.

Safety/Efficacy Profile

The safety and efficacy of ARIDOL as a bronchial challenge test were verified in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL bronchial challenge test in non-asthmatic patients with symptoms suggestive of asthma and clinically diagnosed asthmatic patients six years of age and older. Approved for use in 19 countries, ARIDOL has been used by more than 44,000 patients, and is marketed in Australia, major European countries and Korea. ARIDOL is included in official international guidelines for the clinical assessment of asthma. Organizations and guidelines endorsing ARIDOL include: the International Olympic Committee Medical Commission's Independent Panel on Asthma, the U.S. Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention, the World Anti-Doping Agency and the Australian Asthma Management Handbook. ARIDOL is the only dry powder bronchial challenge test approved for use in the U.S.

Indication

Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.

ARIDOL is not a stand alone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Important Safety Information

WARNING: RISK OF SEVERE BRONCHOSPASM

Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. If severe bronchospasm occurs it should be treated immediately by administration of a short acting inhaled beta-agonist. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV[1] <1-1.5 liters or <70% of the predicted values).

ARIDOL is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules. The product is also contraindicated for patients with medical conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers.

Bronchial challenge testing with ARIDOL should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements.

Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant.

The most common adverse reactions (rate greater than or equal to 1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. No formal drug-drug interaction studies have been conducted with ARIDOL.

About Pharmaxis

Pharmaxis is a global specialty pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and immune disorders. The company's development pipeline includes Bronchitol for cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease (COPD), PXS25 for the treatment of lung fibrosis and PXS4159 for asthma. Founded in 1998, Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company is headquartered in Sydney, Australia with regional offices in the U.S. (Exton, PA), Europe and Asia Pacific. For more information about Pharmaxis, visit www.pharmaxis.com.

(1) Provocholine® (methacholine chloride powder for inhalation) [prescribing information]. Methapharm Inc. January 2008.

(2) Anderson SD, Charlton B, Weiler JM, et al. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009;10:4.

Please call Daina Cardillo at 203-762-8833 for full prescribing information.

SOURCE Pharmaxis, Inc.


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