Novartis Pharmaceuticals Canada receives a Notice of Compliance from Health Canada for Seebri Breezhaler as a long-term once-daily maintenance COPD treatment in Canada

• Seebri™ Breezhaler* 50 mcg is approved for the long-term once-daily maintenance bronchodilation in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and should be available to patients and physicians in Canada early in 2013.
• In clinical trials (GLOW), Seebri™ Breezhaler* improved lung function, reduced shortness of breath, reduced exacerbations, and improved quality of life up to 52 weeks versus placebo [1], [2], [3].

DORVAL, QC, Oct. 22, 2012 /CNW/ - Novartis Pharmaceuticals Canada Inc. announced today that Health Canada has approved Seebri™ Breezhaler* (glycopyrronium bromide) 50 mcg inhalation powder hard capsules, as a long-term once-daily maintenance Long-Acting Muscarinic Antagonists (LAMA) bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

"We are proud that Canada is the third health authority worldwide to have approved Seebri™ Breezhaler*," noted Dr. Riad Sherif B., President of Novartis Canada. "Novartis' commitment to science and drug development is bringing new treatments to this disabling respiratory disease. This approval is a critical milestone for physicians and patients, offering them a new once-daily COPD therapy," concluded Dr. Sherif.

Health Canada approved Seebri™ Breezhaler* based on data from the Novartis Phase III GLOW trials which demonstrated the safety and efficacy of glycopyrronium 50 mcg and involved 1,996 COPD patients who required maintena
nce treatment from around the world, including Canada [1], [2], [3] .

The GLOW trials showed that glycopyrronium, when compared to placebo, significantly improved lung function after morning dosing and that this benefit was sustained for 24 hours over a 52-week period [2]. Patients on glycopyrronium demonstrated improved lung function, reduced shortness of breath, reduced exacerbations, reduced use of rescue medication, improved quality of life and improved exercise tolerance compared to placebo [1], [2], [3].

GLOW1 was a 26-week, randomized, double-blind, placebo-controlled study. The study demonstrated the clinically significant superiority of glycopyrronium versus placebo for lung function improvements at 12 weeks (primary endpoint) measured by trough FEV1 (p0.001) [1].

GLOW2 was a 52-week, randomized, double-blind, placebo-controlled study with open label tiotropium 18 mcg as an active exploratory arm [2]. GLOW2 demonstrated a similar magnitude of effect over 52 weeks measured by improvements in trough FEV1 compared to placebo. In addition to demonstrating benefits in terms of lung function, glycopyrronium exhibited a rapid onset of action within five minutes at first dose and reduced exacerbations. Benefits in both breathlessness and health-related quality of life (HRQL), as measured by the Transition Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) compared to placebo, were also demonstrated.

The GLOW3 study showed that after glycopyrronium was administered in the morning, patients experienced improved exercise tolerance from the first dose onward. Overall, patients treated with glycopyrronium experienced a significant 21% improvement in exercise endurance versus placebo at the end of the study (day 21).
The safety profile of Seebri™ Breezhaler* is characterized by symptoms related to the anticholinergic effect including dry mouth while other gastrointestinal effects and signs of urinary retention were infrequent. Adverse drug reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.

Seebri™ Breezhaler* is a long-acting muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in COPD global treatment strategies as maintenance therapy.

About COPD
COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide [9] and is predicted to be the third leading cause of death by 2020 [10]. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted at the peak of their earning power and family responsibilities [11].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "expected," "commitment," "developing," "committed," "being investigated," "designed to," "being developed," or similar expressions, or by express or implied discussions regarding potential additional marketing approvals for Novartis respiratory products or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any Novartis respiratory products will obtain any additional marketing approvals. Nor can there be any guarantee that such products will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2011, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. It was named for the seventh time as one of the "50 Best Employers in Canada" for 2011. For further information, please consult www.novartis.ca.

References
[1] D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011, 12:156.
[2] Kerwin E, et al. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with moderate-to-severe COPD over 52 weeks: The GLOW2 study. Eur Resp J. 2012. Published on July 26, 2012 (doi:10.1183/09031936.00040712). Last accessed 12 September 2012.
[3] Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves exercise endurance from first dose in patients with COPD: the GLOW3 trial. Int J Chron Obstruct Pulmon Dis. 2012; 7:503-513.
[4] Onbrez* Breezhaler* (indacaterol) Product Monograph dated December 5, 2011. Available at: http://webprod5.hc-sc.gc.ca/dpd-bdpp/newSearch-nouvelleRecherche.do?lang...
[5] Donohue JF, Fogarty C, Lötvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: Indacaterol versus tiotropium. Am J Respir Crit Care Med 2010;182:155-162.
[6] Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD. Thorax 2010;65(6):473-9.
[7] Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J 2011;37:273-279.
[8] Balint B, Watz H, Amos C, et al. Onset of action of indacaterol in patients with COPD: Comparison with salbutamol and salmeterol-fluticasone. Int J Chron Obstruct Pulmon Dis 2010;5:311-318.
[9] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 12 September 2012.
[10] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011.
[11] Fletcher MJ et al., COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.

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SOURCE: Novartis Pharmaceuticals Canada Inc.

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