* Phase III INSIST study shows once-daily Onbrez Breezhaler gave better
24-hour bronchodilation than twice-daily salmeterol[1], a current mainstay
of treatment
* Data show Onbrez Breezhaler significantly reduced use of rescue medication
in patients with chronic obstructive pulmonary disease (COPD)[1]
* New results provide further evidence that Onbrez Breezhaler is a highly
effective treatment option for patients with this potentially
life-threatening disease
Basel, September 19, 2010 - Results of the Phase III INSIST study show that
Onbrez® Breezhaler® (indacaterol) given once-daily is significantly better at
improving lung function and reducing breathlessness than twice-daily
salmeterol[1], one of the current mainstays of treatment for patients with
chronic obstructive pulmonary disease (COPD).
Patients with COPD using the novel Onbrez Breezhaler were also able to reduce
their use of rescue medication compared to those using salmeterol[1], a widely
prescribed drug in the long-acting beta-2 agonist (LABA) class. Onbrez
Breezhaler has been described in scientific literature as the first "ultra-LABA"
reflecting its longer duration of action compared to older LABAs[2].
Data from the INSIST study involving 1,123 patients aged 40 years or above in
seven countries were presented today at the European Respiratory Society (ERS)
congress in Barcelona, Spain. Results showed that Onbrez Breezhaler 150 µg
once-daily provided superior 24-hour bronchodilation to salmeterol 50 µg
twice-daily at the end of 12 weeks' treatment[1].
"Patients with COPD require treatment that combines a sustained improvement in
lung function with better clinical outcomes," said the study's principal
investigator, Dr Stephanie Korn from the Pulmonary Department at Mainz
University Hospital in Germany. "The results of INSIST confirm that indacaterol
is potentially an attractive maintenance treatment option for these patients."
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. Although often
considered a disease of the elderly, research has shown that a majority of COPD
patients are under the age of 65[3], when they are likely to be at the peak of
their earning power and family responsibilities.
INSIST was a 12-week, randomized, double-blind, head-to-head study involving
patients with moderate-to-severe COPD (as defined by the GOLD 2007 criteria[4]).
The study met its primary endpoint with Onbrez Breezhaler giving superior
bronchodilation to salmeterol at week 12[1]. This was assessed by measuring
patients' forced expiratory volume of breath in one second (FEV1) from five
minutes to 11 hours 45 minutes post-dose (mean difference in FEV1 area under
curve 60 mL, p<0.001)[1]. Onbrez Breezhaler showed superiority for this
assessment in all subgroups of patients[1].
In addition, Onbrez Breezhaler significantly increased the proportion of
patients with a clinically relevant reduction in breathlessness compared to
salmeterol (69.4% vs. 62.7% achieved a score of at least one in the transition
dyspnea index, p<0.05), and the number of days on which patients did not require
rescue medication (mean difference 4.4%, p<0.05)[1]. Both treatments were well
tolerated in the study[1].
"By demonstrating the benefits that Onbrez Breezhaler can bring to patients with
COPD, this study affirms our confidence in this medicine and in the
indacaterol-based combination therapies currently under development," said
Trevor Mundel, MD, Global Head of Development at Novartis AG. "Novartis is
committed to providing innovative treatment options for patients with COPD and
their physicians as part of our long-standing involvement in the field of
respiratory medicine."
The INSIST study findings are supported by recently published data from the
26-week INLIGHT-2 Phase III study involving 1,002 patients with
moderate-to-severe COPD[5]. In this study, Onbrez Breezhaler 150 µg once-daily
provided a greater improvement in lung function after 12 weeks than salmeterol
50 µg twice-daily or placebo (24-hour trough FEV1 increased by 60 mL more than
salmeterol and 170 mL more than placebo, both p<0.001)[5]. Safety profiles were
similar across the treatment groups and both active treatments were well
tolerated[5].
Onbrez Breezhaler is approved in more than 40 countries including the European
Union, Switzerland, Australia, India, Indonesia, Korea, and a number of
countries in Latin America. It is indicated in Europe for the maintenance
bronchodilator treatment of airflow obstruction in adult patients with COPD[6].
US approval is subject to the FDA's review of additional clinical data that
Novartis expects to file by the end of 2010.
In clinical studies, the most commonly reported adverse reactions with Onbrez
Breezhaler were nasopharyngitis, upper respiratory tract infection, cough and
headache[6].
COPD affects 210 million people worldwide[7] and is projected to be the third
leading cause of death by 2020[8]. The symptoms cause profound disability and
COPD is a major burden on individual patients, their families, and society at
large. Early diagnosis and effective treatment are a key priority, because
although COPD is incurable, the disease is manageable with appropriate
therapies.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potentially," "can," "expects," "confidence,"
"development," "commitment," or similar expressions, or by express or implied
discussions regarding potential additional marketing approvals for Onbrez
Breezhaler or regarding potential future revenues from Onbrez Breezhaler. 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 Breezhaler 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 approved for sale in
any additional markets. Nor can there be any guarantee that Onbrez Breezhaler
will achieve any particular levels of revenue in the future. In particular,
management's expectations regarding Onbrez Breezhaler 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 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
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these areas. In 2009, the Group's continuing operations achieved net sales of
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Group companies employ approximately 102,000 full-time-equivalent associates and
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please visithttp://www.novartis.com.
Sunday, September 19, 2010
Novartis study shows Onbrez® Breezhaler® is superior to salmeterol in reducing breathlessness for patients with COPD
8:23 PM
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