Health Canada approves SYMBICORT(R) TURBUHALER(R) for chronic obstructive
pulmonary disease - Increasing patients' quality of life and reducing
exacerbations

~ Clinical studies also demonstrate that SYMBICORT TURBUHALER with tiotropium, provides rapid relief and significant improvements over challenging morning symptoms ~

MISSISSAUGA, ON, Jan. 14 /CNW/ - AstraZeneca Canada Inc. announced today that Health Canada has approved SYMBICORT TURBUHALER (budesonide/formoterol) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema for as many as 750,000 Canadians who have the condition(1). COPD is a chronic lung disease that progressively damages the airways that go in and out of the lungs(2). With an established history in respiratory disease, SYMBICORT TURBUHALER is also approved by Health Canada for the regular treatment of asthma(3).

The use of SYMBICORT TURBUHALER in the treatment of patients with moderate to severe COPD is supported by two 12-month, randomized, double-blind, placebo-controlled, parallel-group, multicentre clinical studies comparing efficacy and safety of SYMBICORT with placebo, budesonide, and formoterol(3). SYMBICORT TURBUHALER was shown to be effective in reducing exacerbations and providing early and sustained improvements in lung function and symptoms, together with improvements in health-related quality of life(4).

In addition, data from the recent CLIMB study found that patients taking SYMICORT TURBUHALER when used in combination with tiotropium, benefited significantly with rapid improved lung function and a greater ability to carry out morning activities compared to those treated with tiotropium alone(5). The reported benefits were evident after one week of treatment, and continued to improve over the treatment period(5).

"The Health Canada approval is exciting news for Canadians living with COPD, especially as SYMBICORT TURBUHALER has been seen to provide patients with an increased quality of life and a reduction in exacerbations," says Dr. Meyer Balter, Director, Asthma and COPD Education Clinic, Mount Sinai Hospital. "In addition, clinical trials have shown it to have a fast onset of action and ease the morning symptoms of COPD, giving patients a better start to their day, enabling them to live a more active life."

For patients with COPD, the morning is typically a time when symptoms are most aggravated(6). The most common morning activities that have been reported as being significantly affected by severe COPD symptoms include walking up/down stairs, putting on shoes/socks, and making the bed, followed by dressing, and showering/bathing(6).

    
    About COPD in Canada
    --------------------
    

As many as 750,000 Canadians suffer from COPD(1), though 1.6 million Canadians report experiencing COPD symptoms without a diagnosis(2). Common symptoms of COPD include shortness of breath, wheezing, frequent and long-lasting lung infections (the flu, pneumonia, etc.), feeling tired(2) and coughing with phlegm(7). The leading cause of COPD is smoking cigarettes, which occurs in 80 to 90 per cent of cases(2).

    
    About SYMBICORT TURBUHALER
    --------------------------
    

SYMBICORT TURBUHALER is indicated for the maintenance treatment of moderate to severe COPD including chronic bronchitis and emphysema(3). For patients with moderate to severe COPD, the approved dosage of SYMBICORT TURBUHALER is 200/6 mcg two inhalations twice daily(3). SYMBICORT TURBUHALER is also indicated for the regular treatment of asthma in patients 12 years of age and older(3). SYMBICORT TURBUHALER is a combination of two proven respiratory medications - budesonide, an inhaled corticosteroid (ICS) to treat inflammation, and formoterol, a rapid and long-acting beta(2)-agonist (LABA) to address bronchoconstriction. SYMBICORT TURBUHALER does not replace fast-acting inhalers and should not be initiated to treat acute symptoms of COPD or asthma(3). SYMBICORT TURBUHALER is approved for use in the treatment of COPD in 96 countries worldwide.

    
    About AstraZeneca
    -----------------
    

AstraZeneca is a leading global pharmaceutical company with an extensive product portfolio spanning six major therapeutic areas: gastrointestinal, cardiovascular, infection, neuroscience, oncology, and respiratory. AstraZeneca's Canadian headquarters are located in Mississauga, Ontario, with a state-of-the-art drug discovery centre based in Montreal, Quebec. For more information, visit the company's website at www.astrazeneca.ca.

    
    References:
    -----------------------------
    (1) Canadian Lung Association; Respiratory Guidelines (2008).
        http://www.lung.ca/cts-sct/pdf/Brochure-COPD.pdf. Last accessed
        August 19, 2009.
    (2) Canadian Lung Association.
        http://www.lung.ca/diseases-maladies/copd-mpoc/what-quoi/index_e.php.
        Last accessed July 30, 2009.
    (3) SYMBICORT Product Monograph. July 29, 2009
    (4) Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of
        budesonide/formoterol in the management of chronic obstructive
        pulmonary disease. European Respiratory Journal; 2003: 21: 74-81
    (5) Welte T, Miravitlles M, Hernandez P et al. Efficacy and tolerability
        of Budesonide/formoterol added to tiotropium in COPD patients.
        American Journal of Respiratory and Critical Care Medicine; 2009:
        108: 741-750.
    (6) Partridge MR, Karlsson N, Small IR. Patient insight into the impact
        of chronic obstructive pulmonary disease in the morning: an internet
        survey. Current Medical Research and Opinion 2009; 25:2043-8
    (7) Canadian Lung Association.
    http://www.lung.ca/diseases-maladies/copd-mpoc/signs-signes/index_e.php.
        Last accessed July 30, 2009.
    

SOURCE AstraZeneca Canada Inc.

For further information: For further information: Marsha Knoll, Edelman, (416) 979-1120, ext. 329, marsha.knoll@edelman.com


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