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Biopharmaceuticals Drug Delivery

 News Release - October 17, 2006

Advair(R) HFA Inhalation Aerosol Now Available

New Metered-Dose Inhaler Allows Asthma Patients to Receive Benefits of Advair Diskus(R) in Alternative Device

RESEARCH TRIANGLE PARK, N.C., Oct. 17 (HSMN NewsFeed) -- Advair HFA Inhalation Aerosol, a new formulation combining fluticasone propionate and salmeterol in a metered-dose inhaler (MDI) delivery device, is now available in pharmacies nationwide. AdvairŪ, a medicine used in the treatment of asthma, became available in 2001 as a dry-powdered inhaler known as Advair Diskus (fluticasone propionate and salmeterol).

Advair HFA offers asthma patients who are unable to use dry-powder inhalers an alternative delivery system. Like Advair Diskus, Advair HFA contains both an inhaled corticosteroid and an inhaled long-acting bronchodilator to effectively treat the two main causes of asthma symptoms -- airway inflammation and constriction.

"The availability of Advair in a metered-dose inhaler is good news for asthma patients," said Robert A. Nathan, MD, Clinical Professor of Medicine at the University of Colorado Health Sciences Center and a lead study investigator for Advair HFA. "It lets those who need an alternative delivery method to the dry-powder inhalers achieve a comparable level of effectiveness to that of Advair Diskus, but in a device that may be more appropriate for their needs."

Use of concurrent therapy, like Advair, is supported by the National Institutes of Health (NIH) Guidelines for the Diagnosis and Management of Asthma, which position an inhaled corticosteroid and a long-acting beta2-agonist as preferred therapy for patients with moderate to severe persistent asthma.

Advair HFA Inhalation Aerosol is an environmentally-friendly formulation, developed in accordance with the Montreal Protocol on the use of propellants, and contains hydrofluoroalkane (HFA-134a) to propel the medication out of the canister rather than a chlorofluorocarbon (CFC) propellant that has been linked to ozone depletion in the atmosphere.

Advair HFA is available in three strengths, Advair HFA 45/21, Advair HFA 115/21 and Advair HFA 230/21. Each 12-gram canister of Advair HFA provides 120 metered inhalations. Advair HFA is indicated for the long-term twice-daily maintenance treatment of asthma in patients 12 years of age and older.

Clinical Trial Information

The efficacy and safety of Advair HFA was established in four double-blind, parallel-group clinical trials of 1,517 adolescent and adult patients greater than or equal to 12 years with asthma not optimally controlled on current therapy. These studies compared Advair HFA to fluticasone propionate or salmeterol alone, and improvements in most efficacy endpoints were greater with Advair HFA than with the individual components. In addition, clinical trials showed comparable results between Advair HFA and Advair Diskus.

In a year-long safety study of 325 patients taking Advair HFA 45/21, 115/21 and 230/21 improvements in forced expiratory volume in one second (FEV1) (0.17 to 0.35L at 4 weeks) were seen across all 3 treatments with Advair HFA and were sustained throughout the 52-week treatment period. A few patients (3%) were withdrawn due to worsening asthma over one year.

About Asthma

For many of the more than 20 million Americans with asthma, undertreatment of the disease can lead to frequent symptoms and attacks, activity limitation, and a decline in lung function. Research has established that the two main components of asthma are inflammation, or swelling inside the airways, and constriction, or tightening of the muscles that surround the airways. Both of these components play crucial roles in causing asthma symptoms such as shortness of breath, wheezing, chest tightness and cough. Optimal therapy for many patients with persistent moderate to severe asthma requires treatment of both of these components.

Each year, asthma causes nearly two million emergency room visits and approximately 4,000 deaths. Approximately $16 billion in direct healthcare costs and indirect costs, such as lost workdays and productivity, are due to asthma each year.

About Advair HFA

Advair HFA is approved for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age and older. Because LABAs may increase the risk of asthma-related death, Advair is for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Advair is not approved for patients whose asthma can be successfully managed with an ICS along with occasional use of short-acting beta-agonists. Advair is not indicated for the relief of acute bronchospasm.

People should speak to their doctor about the risks and benefits of treating their asthma with Advair. People taking Advair should see their doctor if their asthma does not improve. People should tell their doctor if they have a heart condition or high blood pressure. Some people may experience increased blood pressure, heart rate, or changes in heart rhythm. See full Prescribing Information and Medication Guide for important product information.

About GlaxoSmithKline

Advair HFA was developed and is marketed by GlaxoSmithKline, a research-based pharmaceutical and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For more information on GlaxoSmithKline visit

Contact Lisa Behrens 919-483-2839 or visit for full prescribing information.

Source: GlaxoSmithKline

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