Novartis Phase III study shows once-daily NVA237 is superior to placebo and similar to tiotropium in improving lung function in COPD
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Novartis International AG /
Novartis Phase III study shows once-daily NVA237 is superior to placebo and
similar to tiotropium in improving lung function in COPD
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* GLOW2 study shows NVA237 provides superior 24-hour bronchodilation to
placebo (p<0.001) with comparable efficacy to open-label tiotropium at 12
weeks[1]
* NVA237 shown to be well-tolerated in patients with moderate-to-severe
chronic obstructive pulmonary disease (COPD)[1]
* Phase III data support first regulatory submission for NVA237 by end of
2011
Basel, June 30, 2011 - Results from the pivotal Phase III GLOW2 clinical trial
show that once-daily NVA237 (glycopyrronium bromide) 50 mcg significantly
improved lung function in patients with moderate-to-severe chronic obstructive
pulmonary disease (COPD) relative to placebo (p<0.001), with similar efficacy to
open-label tiotropium[1].
Further efficacy and safety results from GLOW2 will be presented at a scientific
congress in 2012, and the data will be used to support an application for
regulatory approval to be filed before the end of 2011.
"NVA237 has demonstrated its potential benefit for COPD patients in two large
pivotal Phase III studies, " said Trevor Mundel, MD, Global Head of Development
at Novartis Pharmaceuticals. "This new study adds to the growing evidence that
NVA237 could be an important treatment option for COPD, and supports our plans
to develop a fixed-dose combination with our long-acting beta(2)-agonist
Onbrez(®) Breezhaler(®) (indacaterol)."
In an exploratory arm of the study, NVA237 was compared with open-label
tiotropium (Spiriva(®) HandiHaler(®*)) 18 mcg, another once-daily long-acting
muscarinic antagonist (LAMA) indicated for the treatment of COPD. Results show
that NVA237 produced similar improvements in lung function to tiotropium[1].
The study met its primary endpoint by demonstrating superior 24-hour
bronchodilation to placebo at 12 weeks measured by trough FEV(1) (i.e. forced
expiratory volume in one second), a standard measure of lung function[1]. NVA237
was delivered using the Concept1(®) device, a single-dose dry-powder inhaler.
Key secondary endpoints were improvement in breathlessness assessed using the
Transition Dyspnea Index (TDI) at 26 weeks, and improved quality of life as
measured by the St George´s Respiratory Questionnaire (SGRQ) at 52 weeks.
Important secondary endpoints were time to first COPD exacerbation and use of
rescue medication during 52 weeks of treatment. The study met all of these
endpoints.
The GLOW2 study also showed that NVA237 was well-tolerated with a similar
incidence of adverse events for patients treated with NVA237, placebo and open-
label tiotropium[1].
GLOW2 was a 52-week double-blind, placebo-controlled, parallel-group study
involving 1,066 patients to assess the efficacy, safety and tolerability of
NVA237 in patients with COPD. Patients were randomized into three treatment arms
receiving either once-daily NVA237 50 mcg or placebo (double-blind), or once-
daily tiotropium 18 mcg[1] (open label). They were also permitted to use COPD
background therapy and rescue medication.
In April 2011 Novartis announced results from the first Phase III clinical trial
with NVA237. The pivotal double-blind 26-week GLOW1 study met its primary
endpoint by demonstrating superior bronchodilation to placebo at 12 weeks
measured by trough FEV1 (p<0.001)[1]. The incidence of adverse events was
similar in NVA237-treated patients and in those receiving placebo[1]. Further
data from GLOW1 will be presented at the European Respiratory Society congress
in Amsterdam in September 2011.
COPD is a progressive, life-threatening disease associated with tobacco smoking,
air pollution or occupational exposure, which causes obstruction of airflow in
the lungs resulting in debilitating bouts of breathlessness. COPD affects 210
million people worldwide[2] and is projected to be the third leading cause of
death by 2020[3]. Although often considered a disease of the elderly, research
has shown that a majority of COPD patients are under the age of 65[1] when they
are likely to be at the peak of their earning power and family responsibilities.
NVA237 was licensed to Novartis in April 2005 by Vectura and its co-development
partner Sosei.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will, " "to be filed, " "potential, " "could, " "plans, "
"projected, " or similar expressions, or by express or implied discussions
regarding potential marketing submissions or approvals for NVA237 or a potential
combination respiratory product, 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 with such products to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that NVA237 or a potential
combination respiratory product will be submitted approved for sale in any
market, or at any particular time. 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, including uncertainties as to FDA dosing requirements;
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 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, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group´s continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 119,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis
at http://twitter.com/novartis.
* Spiriva(®) and HandiHaler(®) are registered trademarks of Boehringer Ingelheim
Pharma GmbH & Co. KG.
References
[1] Data on file, Novartis Pharma AG.
[2] 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 24
May 2011.
[3] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2010. Available
at:http://www.goldcopd.org/Guidelineitem.asp?l1=2&l2=1&intId=989. Last accessed
24 May 2011.
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