Novartis receives approval in the European Union for Onbrez®
Breezhaler®, a new once-daily bronchodilator for patients with COPD|
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* Onbrez® Breezhaler® demonstrated superiority to tiotropium,
first new inhaled compound for treatment of COPD in seven years
for EU patients
* Onbrez Breezhaler is only treatment for COPD to combine 24-hour
bronchodilation[1,2,3] from a once-daily dose with rapid onset of
action within five minutes[4,5]
* COPD affects 210 million people globally, up to 82 million in
Europe[7,8], and is projected to become the third leading cause
of death worldwide
Basel, December 3, 2009 - Novartis announced today that the European
Commission (EC) has approved Onbrez Breezhaler (QAB149 or
indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily
maintenance bronchodilator treatment of airflow obstruction in adult
patients with chronic obstructive pulmonary disease (COPD).
"Onbrez Breezhaler has demonstrated greater improvements in lung
function, breathlessness and quality of life compared to current
therapies," said Joe Jimenez, CEO of the Novartis Pharmaceuticals
Division. "The EC approval of Onbrez Breezhaler means this new and
effective therapy will soon be available to people in the EU with
COPD and, through better symptom control, will help them to live more
active and productive lives despite their condition."
Onbrez Breezhaler, containing the active ingredient indacaterol
maleate, is the first new inhaled compound for the treatment of COPD
to be made available for EU patients in seven years. Additionally, it
is the first and only treatment to demonstrate in clinical studies
both 24-hour bronchodilation[1,2,3] and a rapid onset of action
within five minutes of inhalation[4,5].
COPD is a progressive, life-threatening respiratory disease that
affects 210 million people worldwide, up to 82 million in
Europe[7,8], the majority of whom are under the age of 65. COPD
impairs lung function resulting in chronic breathlessness. This leads
to a profound, negative impact on patients' ability to work and
support families. COPD currently ranks tenth in overall disease
burden, ahead of asthma and diabetes.
The EC based its approval of Onbrez Breezhaler on data from over
6,000 patients. This data included pivotal Phase III results showing
Onbrez Breezhaler significantly improved lung function and
provided clinically relevant improvement in symptoms of
breathlessness compared to tiotropium. Recent data presented at
the American College of Chest Physicians (ACCP) Chest Conference
showed once-daily Onbrez Breezhaler also achieved significant
improvements in lung function compared to twice-daily salmeterol,
another current treatment option. In addition, Onbrez Breezhaler
provided better health status* and improved breathlessness compared
Onbrez Breezhaler has shown good overall safety and tolerability,
which is comparable to other current treatments[3,14,15]. The most
common adverse drug reactions were nasopharyngitis, cough, upper
respiratory tract infection, and headache. These were in the vast
majority mild or moderate and became less frequent as treatment was
QAB149 was filed with the United States Food and Drug Administration
(FDA) in late 2008. In October 2009, Novartis received a Complete
Response letter from the US. The FDA requested additional information
on the dosing proposed, which Novartis is working to address.
Improving the management of COPD is a priority focus for Novartis and
Onbrez Breezhaler is the lead compound in an expected once-daily
portfolio for the treatment of this growing public health issue.
Novartis has three additional investigational treatments in its
late-stage COPD portfolio, NVA237, QVA149 and QMF149. Novartis is
also exploring new pathways in the treatment of COPD as part of an
innovative, early-stage pipeline with disease modifying potential.
COPD is commonly caused by cigarette smoke and other harmful fumes,
and is characterized by a persistent obstruction of airflow in the
lungs, resulting in breathlessness. COPD is currently projected
to become the third leading cause of death worldwide by 2020.
Bronchodilators are a group of drugs that widen the airways in the
lungs and are considered the cornerstone of COPD treatment, relieving
symptoms and preventing exacerbations. While incurable, COPD is
manageable, and improving airflow with the use of long-acting
bronchodilators is central to symptomatic relief.
*For this study, health status was assessed using St. George's
Respiratory Questionnaire, a standardized self-completed
questionnaire for measuring impaired health and perceived well-being.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "projected," "will," "expected,"
"exploring," "potential," or similar expressions, or by express or
implied discussions regarding potential marketing, additional
marketing approvals for Onbrez Breezhaler or of a potential Novartis
portfolio of 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 Onbrez Breezhaler will be
approved in any additional markets, or that any other potential
components of a Novartis portfolio of respiratory products will be
approved for sale in any market. Nor can there be any guarantee that
such products will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding such
products 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; 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.
Novartis provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in each of these areas. In
2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 99,000 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
1. Fogarty C, Hébert J, Iqbal A et al. Indacaterol once-daily
provides effective 24-h bronchodilation in COPD patients: a
26-week evaluation vs placebo and tiotropium. Eur Respir J
2009;34 (Suppl. 53):P2025.
2. Dahl R, Kolman P, Jack D et al. Bronchodilator therapy with
indacaterol once-daily in COPD: a 52-week comparison with
formoterol. Eur Respir J 2009;34 (Suppl.53):E4350.
3. Kornmann O, Luthra A, Roger Owen R et al. Once-daily indacaterol
provides superior bronchodilation, health status and clinical
outcomes compares with salmeterol in patients with chronic
obstructive pulmonary disease (COPD): A 26-week
placebo-controlled study. Chest 2009;136:152S.
4. Balint B, Watz H, Amos C et al. Fast onset of bronchodilation
with indacaterol in patients with COPD. Eur Respir J 2009;34
5. Vogelmeier C, Ramos-Barbon D, Damon J et al. Once-daily
indacaterol provides effective 24-hour bronchodilation in COPD: A
double-blind comparison with tiotropium. Chest 2009;136:4S.
6. World Health Organization. Factsheet No 315 Chronic obstructive
pulmonary disease (COPD).
27 November 2009).
7. Halbert RJ, Isonaka S, George D et al. Interpreting COPD
Prevalence Estimates. What Is the True Burden of Disease? Chest
8. Lanzieri G. Population in Europe 2007: first results. Eurostat.
Statistics in Focus 81/2008, Population and social conditions.
9. Murray CJ & Lopez AD. Alternative projections of mortality and
disability by cause 1990-2020: Global Burden of Disease Study.
10. NHBLI. What is COPD?
27 November 2009).
11. Data on file, Novartis Pharma AG: MattsonJack COPD Est. 2008 US +
EU5; Global COPD Chart Pull & Attitudinal Study (Quant).
12. World Health Organization 2007. Global surveillance, prevention
and control of chronic respiratory diseases: a comprehensive
approach. Bousquet J, Khaltaev N, editors.
13. Mahler DA, Palange P, Iqbal A et al. Indacaterol once-daily
improves dyspnoea in COPD patients: a 26-week placebo-controlled
study with open-label tiotropium comparison. Eur Respir J 2009;34
14. Worth H, Kleerup E, Iqbal A et al. Safety and tolerability of
Indacaterol once-daily in COPD patients versus placebo and
tiotropium: a 26-week study. Eur Respir J 2009;34
15. Chung KF, Kornmann O, Jack D et al. Safety and tolerability of
indacaterol over 52 weeks of treatment in COPD. Eur Respir J
16. Onbrez® Breezhaler® (Indacaterol) Summary of Product
Characteristics. November 2009 (approved).
17. Global Initiative for Chronic Obstructive Pulmonary Lung Disease.
Global Strategy for the Diagnosis, Management, and Prevention of
Chronic Obstructive Pulmonary Lung Disease. Updated 2008.
http://www.goldcopd.com/download.asp?intId=504 (accessed 10
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