New Novartis data show potential of respiratory portfolio to help COPD patients maintain active and productive lives
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New Novartis data show potential of respiratory portfolio to help COPD patients
maintain active and productive lives
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* Studies show investigational once-daily NVA237 provides superior 24-hour
bronchodilation and increases exercise endurance relative to placebo[1],[2]
* Additional data show NVA237 significantly prolonged time to first moderate/
severe COPD exacerbation and reduced associated hospitalizations[3]
* NVA237 submitted for EU approval under brand-name Seebri(®) Breezhaler(®)
for treatment of chronic obstructive pulmonary disease (COPD)
Basel, September 27, 2011 - Novartis has presented new Phase III data at the
European Respiratory Society (ERS) congress demonstrating the potential for its
portfolio of once-daily inhaled therapies to help patients with chronic
obstructive pulmonary disease (COPD) to maintain more active and productive
lives.
The GLOW1 and GLOW3 studies show that investigational NVA237 (glycopyrronium
bromide) significantly increased patients' lung function compared to placebo
with a fast onset of action at first dose, as well as improving exercise
endurance. NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class
which has recently been submitted for approval in the European Union under the
brand-name Seebri(®) Breezhaler(®).
"These results illustrate the potential benefits of NVA237 for COPD patients and
are especially encouraging as we move ahead with plans to develop a fixed-dose
combination with Onbrez(®) Breezhaler(®), our once-daily therapy in the LABA
class," said David Epstein, Division Head of Novartis Pharmaceuticals. "This
investigational combination of two bronchodilators with complementary modes of
action is designed to give COPD patients access to the two leading classes of
therapy in a single inhaler for the first time."
The studies, presented at the ERS congress in Amsterdam, The Netherlands,
underscore the company's commitment to developing innovative medicines to treat
this life-threatening disease. Although COPD is often thought of as a disease of
the elderly, 50% of patients are estimated to be below the age of 65, and are
likely to be at the peak of their earning power and family
responsibilities[4],[5],[6].
The GLOW1 study met its primary endpoint by showing that NVA237 50 mcg once-
daily produced a significant improvement in lung function of 108 mL in trough
FEV(1)* after 12 weeks in patients with moderate-to-severe COPD compared to
placebo (p<0.001)[1]. Moreover, NVA237 had a rapid onset of action, with a 93 mL
improvement in FEV(1) compared to placebo at five minutes post-dose following
the first dose on the first day of treatment (p<0.001)[1].
NVA237 also significantly prolonged the time to first moderate/severe COPD
exacerbation compared to placebo, and reduced the percentage of associated
hospitalizations[3]. Significant improvement in breathlessness was seen at 26
weeks compared to placebo, accompanied by a significant improvement in health-
related quality of life and reduction in the use of rescue medication[7].
The GLOW3 study investigated the effects of NVA237 50 mcg once-daily on exercise
endurance in moderate-to-severe COPD patients. The study met its primary
endpoint by showing a significant 21% improvement in exercise endurance versus
placebo at the end of the study (i.e. day 21), with a significant 10% increase
from day one (both p<0.001)[2].
Both studies showed that NVA237 was well-tolerated, with a similar incidence of
adverse events for patients treated with NVA237 and placebo[1],[2],[3],[7].
"These results provide important new insights into the potential effects of
NVA237 in improving lung function and relieving symptoms such as
breathlessness," said Dr Kai-Michael Beeh of the insaf Respiratory Research
Institute in Wiesbaden, Germany, the principal investigator of the GLOW3 study.
"The improvements in exercise endurance are significant as exercise limitation
is a considerable burden for COPD patients, affecting everyday activities such
as climbing the stairs. These trials show that NVA237 may provide a future
option that could positively impact the way COPD is treated."
New analyses of Onbrez Breezhaler data at ERS
New pooled analyses of data were also presented confirming the efficacy of
Onbrez Breezhaler (indacaterol), a long-acting beta(2)-agonist (LABA) approved
in more than 70 countries for the maintenance treatment of COPD.
One pooled analysis examined the efficacy of Onbrez Breezhaler in patients with
moderate or less, and severe or worse COPD (defined as stages I-II and III-IV
respectively in the GOLD guidelines[8]). This showed that Onbrez Breezhaler 150
and 300 mcg once-daily significantly improved lung function in both subgroups at
six months compared to placebo (p<0.001)[9]. The analysis also showed that in
the more severe subgroup, Onbrez Breezhaler 300 mcg was significantly more
effective than 150 mcg in improving breathlessness compared to baseline, as
assessed using the Transition Dyspnea Index (TDI) (p<0.05)[9].
A second pooled analysis showed that Onbrez Breezhaler 150 and 300 mcg improved
lung function regardless of patients' background use of ICS. In patients not
using ICS, the improvements in lung function were 180 and 170 mL with Onbrez
Breezhaler 150 and 300 mcg respectively compared to placebo (p<0.001)[10].
Onbrez Breezhaler is the only COPD treatment to offer clinically relevant 24-
hour bronchodilation combined with a rapid onset of action within five minutes
of the first dose. In July 2011, Novartis announced approval of the 75 mcg once-
daily dose in the US under the brand name Arcapta(TM) Neohaler(TM), and of the
150 mcg once-daily dose in Japan under the brand name Onbrez(®) Inhalation
Capsules.
COPD is a progressive disease associated with tobacco smoking, air pollution or
occupational exposure, which causes obstruction of airflow in the lungs
resulting in debilitating bouts of breathlessness. It affects an estimated 210
million people worldwide[11] and is predicted to be the third leading cause of
death by 2020[8].
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 "potential," "encouraging," "plans," "designed,"
"commitment," "could," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for Onbrez
Breezhaler, potential marketing approvals for NVA237 or a potential fixed-dose
combination 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 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 submitted or approved for any
additional indications or labeling in any market. Nor can there be any guarantee
that NVA237 or a potential fixed-dose combination product will be submitted or
approved in any market, or at any particular time. Neither can there be any
guarantee that any of the products referred to in this release 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 clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; 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 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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* Forced expiratory volume of breath in one second
References
[1] D'Urzo, A. NVA237 once-daily provides rapid, clinically meaningful and
sustained 24-h bronchodilation in patients with COPD: The GLOW1 trial.
European Respiratory Society (ERS) Annual Congress 2011. Abstract No. P866.
Presented 25(th) September 2011, 12:50-14:40, Hall 2-19.
[2] Beeh, K. Once-daily NVA237 improves exercise endurance from first dose in
patients with COPD: The GLOW3 Trial. European Respiratory Society (ERS)
Annual Congress 2011. Abstract No. 4497. Late-breaking abstract. Presented
27(th) September 2011, 16:00, Forum.
[3] D'Urzo, A. NVA237 once daily reduces the percentage of patients with
exacerbations of COPD and associated hospitalizations: The GLOW1 trial.
European Respiratory Society (ERS) Annual Congress 2011. Abstract No.
3427. Presented 27(th) September 2011, 12:00, Room 3.2.
[4] Fletcher, M, 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.
[5] Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, et
al. International variation in the prevalence of COPD [the BOLD Study]: a
population-based prevalence study. Lancet. 2007;370[9589]:741-50.
[6] de Marco R, Accordini S, Cerveri I, Corsico A, Sunyer J, Neukirch F, et al.
An international survey of chronic obstructive pulmonary disease in young
adults according to GOLD stages. Thorax. 2004;59[2]:120-5.
[7] van Noord, JA. NVA237 once daily improves dyspnea and health-related
quality of life (HRQoL) in patients with COPD: The GLOW1 trial. European
Respiratory Society (ERS) Annual Congress 2011. Abstract No. P867.
Presented 25(th) September 2011, 12:50-14:40, Hall 2-19.
[8] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2010.
http://www.goldcopd.org/uploads/users/files/GOLDReport_April112011.pdf.
Last accessed 24 August 2011.
[9] Korn, S. Efficacy of indacaterol is maintained in patients with moderate or
less and severe or worse COPD. European Respiratory Society (ERS) Annual
Congress 2011. Abstract No. P860. Presented 25(th) September,
2011, 12:50-14:40, Hall 2-19.
[10] Dahl, R. Efficacy of indacaterol in COPD is maintained irrespective of
inhaled corticosteroid (ICS) use. European Respiratory Society (ERS) Annual
Congress 2011. Abstract No. P861. Presented 25(th) September,
2011, 12:50-14:40, Hall 2-19.
[11] 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 August 2011.
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Datum: 27.09.2011 - 07:15 Uhr
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