Novartis receives positive CHMP opinion for once-daily Seebri® Breezhaler® to treat COPD patients in the EU
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Novartis receives positive CHMP opinion for once-daily Seebri® Breezhaler® to
treat COPD patients in the EU
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* COPD patients in Phase III GLOW trials experienced improved lung function,
reduced shortness of breath, reduced exacerbations, and improved quality of
life[1],[2],[3],[4]
* GLOW2 study showed Seebri Breezhaler provided 24-hour bronchodilation and
was superior to placebo and similar to open-label tiotropium in improving
lung function[2]
* Seebri Breezhaler is the latest innovation in the Novartis COPD portfolio
and when approved will offer patients an alternative once-daily choice of
LAMA therapy
Basel, June 22, 2012 - Novartis announced today that the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a
positive opinion for Seebri(®) Breezhaler(®) (glycopyrronium/NVA237) 44 mcg
delivered dose (50 mcg glycopyrronium per capsule), as a once-daily inhaled
maintenance bronchodilator treatment to relieve symptoms in adult patients with
chronic obstructive pulmonary disease (COPD). Seebri Breezhaler is a long-acting
muscarinic antagonist (LAMA), a type of bronchodilator that is recommended in
COPD global treatment strategies as maintenance therapy administered either
alone or in combination with other treatments[5].
"This positive opinion for Seebri Breezhaler is a major milestone in our efforts
to offer COPD patients and health care professionals an alternative once-daily
therapy in the LAMA class that has the potential to reduce breathlessness,
increase the capacity to exercise and help improve quality of life," said David
Epstein, Division Head of Novartis Pharmaceuticals. "When approved, Seebri
Breezhaler will be the second innovative once-daily inhaled treatment in the
growing Novartis COPD portfolio delivered using the low-resistance Breezhaler
device that allows patients to hear, feel and see that they have taken the drug
correctly."
Data from three of the Novartis Phase III GLOW trials informed the CHMP's
positive opinion for Seebri Breezhaler and included 1,996 COPD patients from
around the world with many in EU countries[1],[2],[3],[4],[6].
GLOW1 demonstrated the clinically significant superiority of Seebri versus
placebo for lung function improvements at 12 weeks measured by trough FEV(1)
(p<0.01)[1]. GLOW2 demonstrated a similar magnitude of effect and also showed
that Seebri was similar to open-label (OL) tiotropium over 52 weeks measured by
improvements in trough FEV(1 )compared to placebo[2](. )In addition to
demonstrating benefits in terms of lung function, Seebri Breezhaler exhibited a
rapid onset of action within five minutes at first dose[2] and reduced
exacerbations[4]. Significant benefits in both breathlessness and health-related
quality of life, as measured by the Transition Dyspnea Index (TDI) and St.
George's Respiratory Questionnaire (SGRQ) compared to placebo, were also
demonstrated[3].
The GLOW3 study showed that after Seebri Breezhaler was administered in the
morning, patients experienced improved exercise tolerance from the first dose
onward[6]. Overall, patients treated with Seebri Breezhaler experienced a
significant 21% improvement in exercise endurance versus placebo at the end of
the study (day 21), with a significant 10% increase from day one (both
p<0.001)[6].
In all studies, Seebri Breezhaler was well tolerated with an incidence of
adverse events similar to placebo[1],[2],[3],[4],[6].
The European Commission generally follows the recommendations of the CHMP and
usually delivers its final decision within three months of the CHMP
recommendation. Worldwide submissions and reviews of Seebri(®) Breezhaler(®)
(glycopyrronium bromide/NVA237) are ongoing. The US filing for Seebri Breezhaler
is expected in 2014.
About Seebri Breezhaler
Seebri(®) Breezhaler(®) (glycopyrronium bromide/NVA237) is an investigational
LAMA developed as a once-daily inhaled maintenance therapy for the treatment of
COPD. Glycopyrronium bromide was licensed to Novartis in April 2005 by Vectura
and its co-development partner Sosei. It was submitted for regulatory approval
in Europe in Q3 2011 and Japan in Q4 2011.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and
improving their quality of life by providing innovative medicines and devices.
Onbrez(®) Breezhaler(® )(indacaterol maleate) is a long-acting beta-agonist
(LABA) that is the only COPD treatment to offer clinically relevant 24-hour
bronchodilation combined with a rapid onset of action at first
dose[7],[8],[9],[10]. Onbrez Breezhaler has also shown significant improvement
in breathlessness scores compared to placebo and tiotropium[7]. It was first
launched in the EU in 150 mcg and 300 mcg once-daily doses. Most recently,
Novartis launched the 75 mcg once-daily dose in the US under the brand name
Arcapta(TM) Neohaler(TM). It is also available as a 150 mcg once-daily dose in
Japan under the brand name Onbrez(®) Inhalation Capsules.
In addition to Seebri Breezhaler, also under development is QVA149 (indacaterol
maleate 110 mcg/glycopyrronium bromide 50 mcg), an investigational inhaled,
once-daily, fixed dose combination of the LABA indacaterol maleate, and the LAMA
glycopyrronium bromide.
The first four Novartis QVA149 Phase III studies in the treatment of COPD all
met their primary endpoints[11],[12],[13],[14]. The results of the SHINE,
BRIGHT, ENLIGHTEN and ILLUMINATE studies, which are key components of the IGNITE
program, demonstrate the potential of QVA149 in the treatment of
COPD[11],[12],[13],[14].
About COPD
COPD is a progressive disease associated mainly with tobacco smoking, air
pollution or occupational exposure, which can cause obstruction of airflow in
the lungs resulting in debilitating bouts of breathlessness. It affects an
estimated 210 million people worldwide[15] and is predicted to be the third
leading cause of death by 2020[5]. Although COPD is often thought of as a
disease of the elderly, 50% of patients are estimated to be within the ages of
50 and 65, which means that half of the COPD population are likely to be
impacted at the peak of their earning power and family responsibilities[16].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will," "milestone," "potential," "generally follows,"
"usually delivers," "expected," "committed," or similar expressions, or by
express or implied discussions regarding potential marketing submissions or
approvals for Seebri or the timing of such submissions or approvals, or
regarding potential future revenues from Seebri. 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 Seebri to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Seebri will be approved for sale in any market, or submitted for approval
in any additional markets, or that such submissions or approvals will occur at
any particular time. Nor can there be any guarantee that Seebri will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Seebri 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; unexpected
manufacturing issues; 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 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 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
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References
1. D'Urzo A, et al. Efficacy and safety of once-daily NVA237 in patients with
moderate-to-severe COPD: the GLOW1 trial. Respiratory Research
2011, 12:156 (7 December 2011).
2. Kerwin E, et al. NVA237 once daily provides rapid and sustained
bronchodilation in COPD patients, with efficacy similar to tiotropium: The
GLOW2 trial. [Abstract A2920: Thematic poster session B41: Monday, 21 May,
2012; 08:15-16:30].
3. Korenblat P, et al. NVA237 once daily improves dyspnea and health-related
quality of life in patients with COPD: The GLOW2 trial. [Abstract A2254:
Poster discussion session A101: Sunday, 20 May, 2012; 14:00-16:30].
4. Kerwin E, et al. NVA237 once daily reduces COPD exacerbations with similar
rates to tiotropium: The GLOW2 trial. [Abstract A2255: Poster discussion
session A101: Sunday, 20 May, 2012; 14:00-16:30].
5. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2011.
6. Beeh K, Drollmann A, Di Scala L, Smith R. Once-daily NVA237 improves
exercise endurance from first dose in patients with COPD: the GLOW3 trial.
Eur Respir J 2011;38(Suppl. 55):P4497.
7. Donohue JF, Fogarty C, Lötvall J, et al. Once-daily bronchodilators for
chronic obstructive pulmonary disease: Indacaterol versus tiotropium. Am J
Respir Crit Care Med 2010;182:155-162.
8. Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting
inhaled beta2-agonist indacaterol versus twice-daily formoterol in COPD.
Thorax 2010;65(6):473-9.
9. Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol vs twice-
daily salmeterol for COPD: a placebo-controlled comparison. Eur Respir J
2011;37:273-279.
10. Balint B, Watz H, Amos C, et al. Onset of action of indacaterol in patients
with COPD: Comparison with salbutamol and salmeterol-fluticasone. Int J
Chron Obstruct Pulmon Dis 2010;5:311-318.
11. QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG. ClinicalTrials.gov
identifier: NCT01202188.
12. QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01120717.
13. QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG. ClinicalTrials.gov
identifier: NCT01294787.
14. QVA149 2313 (ILLUMINATE). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01315249.
15. 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
22 May 2012.
16. Fletcher MJ 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.
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