Phase III data show Novartis investigational bronchodilator QAB149
significantly improves lung function over current treatments in
COPD[1],[2]
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* Once daily QAB149 (indacaterol) significantly improves lung
function compared to formoterol and tiotropium, two currently
approved COPD treatments, at three months of treatment[1],[2]
* Pending approval, QAB149 could be the first once-daily
bronchodilator to combine clinically relevant 24-hour
bronchodilation with onset of action within five
minutes[3],[4],[5]
* All doses of QAB149 are well-tolerated with a good overall safety
profile in three pivotal trials: INVOLVE (1 year), INHANCE (6
months) and INLIGHT-1 (3 months)[4],[5],[6]
* COPD, a debilitating and progressive respiratory disease, is a
leading and growing cause of death that affects 210 million
people worldwide[7]
Basel, May 21, 2009 - Initial results from three pivotal phase III
trials show the Novartis investigational bronchodilator QAB149
(indacaterol) could deliver clinically relevant* lung function
improvements, within five minutes of the first dose, lasting for 24
hours in patients with chronic obstructive pulmonary disease
(COPD)[3],[4],[5].
The data presented at the American Thoracic Society (ATS) 2009
International Conference in San Diego show that QAB149, a long-acting
beta2-agonist (LABA), significantly improved lung function from the
first day of therapy to up to one year of treatment[1]. The data also
reveal that all evaluated doses of QAB149 were well-tolerated and
had a good overall safety profile[4],[5],[6].
All doses of once-daily QAB149 met the primary efficacy endpoint of
significant improvement in FEV1 (forced expiratory volume in one
second) versus placebo at twelve weeks.[3],[4],[5] This improvement
was seen as early as five minutes post-dose and at every subsequent
time point measured in each study[3],[4],[5]. In INVOLVE QAB149
(300µg and 600µg) also showed significant improvements over
formoterol 12µg in trough FEV1 difference versus placebo at three
months (170ml and 170ml vs. 70ml; p<0.001), and at one year (160ml
and 150ml vs. 50ml; p<0.001)[1].
In addition to data presented at ATS, Novartis released data today
showing that at 12 weeks, QAB149 (150µg and 300µg) achieved
additional improvements of 50ml and 40ml, respectively, versus
open-label tiotropium 18µg, in trough FEV1 or 24-hour post-dose
forced expiratory volume in one second[2]. Further presentation of
study results is planned for later this year.
"Bronchodilator treatment is the first-line approach for the
symptomatic management of patients with COPD, and long-acting
bronchodilators have a number of advantages," said Professor Stephen
I. Rennard, Pulmonary and Critical Care Medicine, University of
Nebraska Medical Center. "The indacaterol data presented at ATS show
that bronchodilation on a once-daily basis may be an important
addition to the current therapeutic armamentarium in COPD."
COPD is a progressive, life-threatening respiratory disease that
affects 210 million people worldwide[7],[8]. Commonly caused by
cigarette smoke and other harmful fumes, COPD is characterized by a
persistent obstruction of airflow in the lungs, resulting in
breathlessness[8]. According to the World Health Organization, COPD
is currently projected to become the third leading cause of death
worldwide by 2030[9]. Bronchodilators are a group of drugs that widen
the airways in the lungs. While COPD is incurable, improving airflow
with the use of long-acting bronchodilators is central to symptomatic
management[10].
"Novartis is committed to developing a range of therapies for
patients with respiratory diseases such as COPD," said Trevor Mundel,
MD, Global Head of Development at Novartis Pharma AG. "QAB149 could
become the foundation of a portfolio of medicines that aims to
improve peoples' respiratory health."
QAB149 is currently undergoing regulatory review in the European
Union and the United States. If approved, QAB149 could become the
foundation of a Novartis portfolio of products, including fixed-dose
combinations, designed to address unmet needs in respiratory care.
Further study results
In the one-year INVOLVE study, QAB149 showed improved symptom control
(cough, wheezing, breathlessness and sputum production and color)
over twice-daily formoterol[11]. In addition, treatment with QAB149
significantly prolonged the time to first COPD flare-up
(exacerbation) compared to placebo[12].
The most commonly-reported adverse effects were nasopharyngitis,
upper respiratory tract infection, headache and cough following
inhalation, which was generally well-tolerated and did not result in
different discontinuation rates between patients experiencing and not
experiencing cough.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "could," "planned," "may,"
"committed," "aims to," "designed to," or similar expressions, or by
express or implied discussions regarding potential marketing
approvals for QAB149 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 QAB149 or 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.
About Novartis
Novartis AG 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 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
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
References
[1] Paggiaro P, et al. "Bronchodilator treatment with indacaterol
once-daily vs formoterol twice-daily in COPD: a 52-week study."
Poster presented at American Thoracic Society (ATS) 2009
International Conference, May 2009.
[2] Novartis data on file.
[3] Dahl, et al. "Indacaterol Once-daily Provides 24-h
Bronchodilation over 52 Weeks of Treatment in COPD." Poster presented
at American Thoracic Society (ATS) 2009 International Conference, May
2009.
[4] Fogarty C, et al. "Sustained 24-h Bronchodilation with QAB149
Once-Daily in COPD: A 26-Week Efficacy and Safety Study." Poster
presented at American Thoracic Society (ATS) 2009 International
Conference, May 2009.
[5] Siler T, et al. "Efficacy and safety of indacaterol 150 µg
once-daily in COPD: 1 12-week study." Poster presented at American
Thoracic Society (ATS) 2009 International Conference, May 2009.
[6] Chung KF, et al. "Safety and Tolerability of Indacaterol over 52
Weeks of Treatment in COPD." Poster presented at American Thoracic
Society (ATS) 2009 International Conference, May 2009.
[7] World Health Organization. Factsheet No 315 Chronic obstructive
pulmonary disease (COPD).
http://www.who.int/mediacentre/factsheets/fs315/en/index.html
(accessed 10 April 2009).
[8] NHBLI. What is COPD?
http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html
(accessed 10 April 2009)
[9] World Health Organisation. COPD predicted to be third leading
cause of death in 2030.
http://www.who.int/gard/news_events/World_Health_Statistics_2008/en/index.html
(accessed 22 April 2009)
[10] Global Initiative for Chronic Obstructive Pulmonary Lung
Disease. Global Strategy for the Diagnosis, Management, and
Prevention of Chronic Obstructive Pulmonary Lung Disease. Updated
2007.
[11] Nonikov V, et al. "Indacaterol Once-daily Reduces Days of Poor
Control in COPD Over 52 Weeks of Treatment." Poster presented at
American Thoracic Society (ATS) 2009 International Conference, May
2009.
[12] Buhl R, et al. "Indacaterol once-daily reduces COPD
exacerbations over 52 weeks of treatment." Poster presented at
American Thoracic Society (ATS) 2009 International Conference, May
2009.
* Defined as >120mL more than placebo in forced expiratory volume in
one second (FEV1) a standard measure of lung function.
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