Novartis receives approval in Japan for Onbrez® Inhalation Capsules, a novel once-daily bronchodilator therapy for patients with COPD
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Novartis International AG /
Novartis receives approval in Japan for Onbrez® Inhalation Capsules, a novel
once-daily bronchodilator therapy for patients with COPD
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* Onbrez is the only once-daily long-acting beta(2)-agonist (LABA) approved in
Japan for treatment of chronic obstructive pulmonary disease
* Clinical data show that Onbrez provides rapid and sustained improvement in
lung function lasting for 24 hours, and improves breathlessness and quality
of life[1-6]
* COPD is a progressive lung disease causing disability and death that could
affect up to 5.3 million people in Japan[7]
Basel, July 1, 2011 - Novartis announced today that it has received regulatory
approval in Japan for Onbrez(®) Inhalation Capsules (indacaterol) 150 mcg once-
daily for the treatment of chronic obstructive pulmonary disease (COPD). Onbrez
is the only once-daily COPD therapy to combine improvements in lung function
lasting for 24 hours[1], [2], [3] with a rapid onset of action within five minutes
of the first dose[4], [5].
"Indacaterol is a novel bronchodilator that offers a unique combination of fast-
and long-acting properties, " said Senior Professor Atsushi Nagai of the First
Department of Medicine at Tokyo Women´s Medical University. "In addition to the
convenience of once-daily dosing, it has shown benefits in terms of reduced
breathlessness and improved quality of life, and could provide a promising new
treatment option for Japanese patients with COPD."
Onbrez, delivered using the Breezhaler(®) device, belongs to the long-acting
beta(2)-agonist (LABA) class of medicines which help to reduce the symptoms of
breathlessness, cough and sputum in COPD patients by increasing bronchodilation,
or airflow into the lungs. The Japanese Ministry of Health, Labor and Welfare
(MHLW) has approved Onbrez for relief of symptoms due to airway obstruction in
COPD (chronic bronchitis and emphysema).
The submission was supported by a clinical trial program that included three
local clinical studies. The pivotal 12-week Phase III study was conducted in
Japan and five other Asian countries and involved 347 patients with moderate-to-
severe COPD[6]. This study showed that Onbrez given once-daily produced
significant improvements in lung function (measured by trough FEV(1), or forced
expiratory volume of breath in one second) compared to placebo, as well as
reducing breathlessness and improving quality of life[6]. The incidence of
adverse events was lower than for placebo[6]. Altogether, these three studies
involved a total of 388 Japanese patients.
"We are pleased that the health authorities in Japan have recognized the
positive benefit-risk profile of Onbrez for patients suffering from this serious
and life-threatening disease, " said David Epstein, Head of the Pharmaceuticals
Division of Novartis. "Investing in Japan and building upon our leading presence
is a key priority for us, and we welcome the fact that patients there will have
access to this important medicine."
COPD is a chronic, progressive lung disease that is commonly caused by tobacco
smoking, air pollution or occupational exposure, and results in airflow
obstruction and debilitating bouts of breathlessness. Although the latest
figures show only 173,000 people have been diagnosed with COPD in Japan[8],
epidemiological data suggest that the total number of patients could be as high
as 5.3 million[7]. There are concerns that the number of patients could grow in
Japan where smoking rates are high and many people are starting to smoke at an
increasingly early age.
Indacaterol was first approved in November 2009 in the European Union under the
brand-name Onbrez(®) Breezhaler(®) and has now been approved in more than 60
countries, including Turkey in May 2011. It is available in more than 30
countries with additional launches planned during 2011. In the US, the Food and
Drug Administration (FDA) is expected to complete its review of the new drug
application by July 2011. If approved in the US the brand name will be
Arcapta((TM)) Neohaler((TM)).
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "could, " "promising, " "priority, " "will, " "launches, "
"planned, " "expected, " "proposed, " or similar expressions, or by express or
implied discussions regarding potential additional marketing approvals for
Onbrez, or the timing or any such approvals, or regarding potential future
revenues from Onbrez. 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 Onbrez to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that Onbrez will be
approved for sale in any additional markets, or at any particular time. Nor can
there be any guarantee that Onbrez will achieve any particular levels of revenue
in the future. In particular, management´s expectations regarding Onbrez 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 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 visit http://www.novartis.com.
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References
[1] 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.
[2] 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.
[3] 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.
[4] 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.
[5] Vogelmeier C, Ramos-Barbon D, Damon J, et al. Indacaterol provides 24-hour
bronchodilation in COPD: a placebo-controlled blinded comparison with
tiotropium. Respir Res 2010;11(1):135.
[6] Kinoshita M, et al. Efficacy and safety of indacaterol 150 and 300 mcg in
Asian COPD patients: A 12-week, placebo controlled study. Presented at American
Thoracic Society (ATS) International Conference, Denver, Colorado, May 2011.
[7] The Nippon COPD Epidemiology (NICE) Study - Fukuchi, et al. Respirology
2004.
[8] 2008 Patient Study. Ministry of Health, Labor and Welfare.
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