Novartis Pharmaceuticals Canada Inc. receives Health Canada approval for Ultibro(TM) Breezhaler®, a once-daily dual bronchodilator for COPD

January 13, 2014
        --  Ultibro(TM) Breezhaler®1(QVA149), a long-term once-daily
            dual bronchodilator, received Health Canada approval on
            December 23rd 2013 for the treatment of airflow obstruction in
            patients with chronic obstructive pulmonary disease (COPD),
            including chronic bronchitis and emphysema
        --  Pivotal Phase III IGNITE data showed QVA149 significantly
            improved lung function and patient-reported outcomes including
            breathlessness and rescue medication use, compared to current
            standards of care2,3,4

DORVAL, QC, Jan. 13, 2014 /CNW/ – Novartis Pharmaceuticals Canada Inc.
(Novartis) announced today that Health Canada has approved the use of
long-term once-daily dual bronchodilator Ultibro(TM) Breezhaler(® )(indacaterol 110 mcg / glycopyrronium 50 mcg) as a maintenance
bronchodilator treatment of airflow obstruction in patients with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and emphysema.

“The availability of ULTIBRO® BREEZHALER® is good news for my patients
with COPD who struggle with disabling breathlessness as they attempt
simple everyday tasks.” says Dr. Kenneth Chapman, Director, Asthma &
Airway Centre of the University Health Network, located in Toronto. “A
new treatment option that improves lung function and relieves
breathlessness around the clock following just one inhalation is a
welcome advance.”

Health Canada approved Ultibro(TM) Breezhaler(®) based on five studies from the IGNITE clinical program (SHINE(2), ILLUMINATE(3), SPARK(4), BRIGHT(5) and ENLIGHTEN(6) studies). These studies showed that QVA149 provided rapid and sustained
improvements in lung function, and significantly reduced shortness of
breath. These improvements were maintained throughout the duration of
the trials(13,14). The IGNITE clinical program is one of the largest international phase
III clinical trial programs in COPD, with 11 trials in total and more
than 10 000 patients involved.( 2-12)

Ultibro(TM) Breezhaler(®) is a fixed-dose combination (FDC) of two bronchodilators, Onbrez(®) Breezhaler(®15 )(indacaterol maleate), a long-acting beta(2)-adrenergic agonist (LABA) and Seebri(®) Breezhaler(®16 )(glycopyrronium bromide), a long-acting anticholinergic (LAAC). Both are
currently used by healthcare professionals as individual therapies to
treat COPD in Canada.

“COPD is known to affect an estimated 210 million people worldwide(17 )and is projected to be the third leading cause of death by 2020(18). Several patients find COPD symptoms really tough to cope with – even
if they’re already taking treatment,” said Dr. Riad Sherif, President
of Novartis. “With the approval of Ultibro(TM) Breezhaler(®), Novartis is pleased that Health Canada recognizes the efficacy of dual
therapy, which has the potential to make a real difference for those
with COPD.”

About the IGNITE clinical trial program

In the Phase III IGNITE clinical trial program, Ultibro(TM) Breezhaler(®) (QVA149) was investigated for the treatment of COPD patients as an
inhaled FDC of indacaterol maleate and glycopyrronium bromide. IGNITE
is one of the largest international clinical trial programs in COPD
comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN,
10,000* patients across 52 countries(2-12,19,20). The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK,
BLAZE, ARISE, BEACON) completed in 2012. The studies are designed to
investigate the efficacy, safety and tolerability, lung function,
exercise endurance, exacerbations, shortness of breath and quality of
life in patients treated with QVA149.

Results from the Phase III IGNITE trials(2-12) demonstrated statistically significant improvements in bronchodilation
with Ultibro(TM) Breezhaler(®) versus placebo. Data showed that Ultibro(TM) Breezhaler(®) significantly improved bronchodilation providing a rapid onset and
sustained bronchodilation during a 24-hour period which was maintained
for up to 26 weeks(21). In the IGNITE Phase III trial program, Ultibro(TM) Breezhaler(®) also showed symptomatic improvements versus placebo in COPD patients(2,4,5,13). These symptomatic improvements included shortness of breath, exercise
tolerance, rescue medication use and health-related quality of life(2,4,5,13).

In clinical studies, Ultibro(TM) Breezhaler(®) demonstrated an acceptable safety profile with no meaningful
differences between the treatment groups in the incidence of adverse
and serious adverse events(2,3,4,5,21). The most common adverse drug reactions related to Ultibro(TM) Breezhaler(®) were cough and oropharyngeal pain(1).

*Total refers to all 11 IGNITE studies.

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of patients
with respiratory diseases and improving their quality of life by
providing innovative medicines and devices.

Available in Canada, Onbrez(®) Breezhaler(® )(indacaterol maleate) 75 mcg is a long-acting 2-agonist (LABA)
indicated for long-term maintenance bronchodilator treatment of airflow
obstruction in patients with COPD, including chronic bronchitis and

Also approved for use in Canada, once-daily Seebri(®) Breezhaler(® )(glycopyrronium bromide) 50 mcg is a novel inhaled long-acting
anticholinergic (LAAC; also referred to as a long-acting muscarinic
antagonist) indicated as a maintenance bronchodilator treatment in
patients with COPD, including chronic bronchitis and emphysema(16).

About COPD

COPD is a progressive life-threatening disease that makes it hard to
breathe, with symptoms that have a destructive impact on patients’
function and quality of life(18,22). It affects an estimated 210 million people worldwide(17 )and is projected to be the third leading cause of death by 2020(18).

COPD is often considered to be a disease of later years, but estimates
suggest that 50% of those with COPD are now less than 65 years old,
resulting in increases in absenteeism, premature retirement and
reductions in workforce participation(23).

In Canada, 2009-2010 estimates show that 4% of Canadians aged 35 and
older are affected. Cigarette smoking is the principal cause,
accounting for 80% of COPD deaths(24).

About Novartis

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 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.

Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG,
which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the
Group amounted to approximately USD 9.3 billion (USD 9.1 billion
excluding impairment and amortization charges). Novartis Group
companies employ approximately 133,000 full-time equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit www.novartis.com.

(TM)Ultibro is a trademark of Novartis Pharmaceuticals Canada Inc.

®Onbrez, Seebri and Breezhaler are registered trademarks of Novartis
Pharmaceuticals Canada Inc.


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SOURCE Novartis Pharmaceuticals Canada Inc.

Source: PR Newswire

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