Novartis International AG / Major study published in NEJM confirms
Novartis' Ultibro(R) Breezhaler(R) superiority over Seretide(R) in
preventing COPD exacerbations . Processed and transmitted by NASDAQ OMX
Corporate Solutions. The issuer is solely responsible for the content of
this announcement.
-- FLAME study showed consistent superiority of Ultibro(R) Breezhaler(R)
over Seretide(R) across exacerbation outcomes, lung function and
health-related quality of life in COPD patients
-- Ultibro Breezhaler also significantly reduced the rate and prolonged the
time to the first moderate or severe exacerbation, compared to Seretide
-- Results published in the New England Journal of Medicine are anticipated
to have important implications for the care of people living with COPD
The digital press release with multimedia content can be accessed here:
http://multimediacapsule.thomsonone.com/novartis/nejm-publication-of-flame-study-results
Basel, May 15 2016 - Novartis today announced the New England Journal of
Medicine publication of the head-to-head FLAME study comparing the
efficacy of once-daily Ultibro(R) Breezhaler(R)
(indacaterol/glycopyrronium bromide) 110/50 mcg to twice-daily
Seretide(R) (salmeterol/fluticasone [SFC]) 50/500 mcg in reducing
chronic obstructive pulmonary disease (COPD) exacerbations. In addition
to meeting the primary endpoint (non-inferiority), findings demonstrated
the superiority of Ultibro Breezhaler over the widely used inhaled
corticosteroid (ICS)/LABA* combination on exacerbation outcomes[1]. The
published FLAME results are anticipated to impact the future management
and treatment of COPD patients.
* a long-acting beta(2) -adrenergic agonist
Preventing exacerbations is one of the primary goals of long-term care
for COPD patients. These episodes have a detrimental effect on quality
of life and disease progression[2], contributing to further lung
function decline[3],[4] and, in severe cases, hospitalization[5] and
even death[2].
"Reducing exacerbations is absolutely critical to improve outcomes and
quality of life for COPD patients," said Vasant Narasimhan, Global Head
Drug Development and Chief Medical Officer for Novartis. "The FLAME
study has clearly shown that Ultibro Breezhaler is superior to the
current standard of care in reducing exacerbations, marking a shift away
from therapies containing steroids for the optimal treatment of COPD
patients."
The results of FLAME confirmed that Ultibro Breezhaler is superior to
SFC in reducing exacerbation outcomes regardless of a patient's disease
severity and eosinophil levels (a type of white blood cell)[1].
Significantly, compared to SFC, Ultibro Breezhaler both reduced the rate
of moderate or severe exacerbations with a 17% risk reduction (rate
ratio, 0.83), and prolonged the time to the first of these episodes with
a 22% risk reduction (hazard ratio, 0.78)(1) . The safety profiles of
the two treatments were consistent with their known profiles. The
incidence of pneumonia was higher with SFC than Ultibro Breezhaler (3.2%
vs 4.8%: a statistically significant difference)[1].
These data were also presented to the scientific community for the first
time today at the 2016 Annual Meeting of American Thoracic Society (ATS)
in San Francisco, USA.
About FLAME
FLAME was a randomized, double-blind, double-dummy, parallel-group,
non-inferiority, active-controlled 52-week study involving 3,362 COPD
patients and conducted at 356 sites across 43 countries[6].
Results confirmed that Ultibro Breezhaler 110/50 mcg met its primary
endpoint (non-inferiority) and furthermore demonstrated superiority to
SFC 50/500 mcg on the rate of all COPD exacerbations
(mild/moderate/severe) over one year of treatment in COPD patients with
a history of at least one exacerbation in the previous year. Against
further secondary endpoints, Ultibro Breezhaler was also superior
compared to SFC in reducing or improving the following[1]:
-- Rate and time to first moderate or severe COPD exacerbation
-- Time to first COPD exacerbation (mild/moderate/severe)
-- Time to first severe COPD exacerbation
-- Lung function (trough FEV[1])
-- Health-related quality of life (St. George's Respiratory Questionnaire)
FLAME is part of the IGNITE Phase III clinical trial program exploring
Ultibro Breezhaler for the treatment of COPD.
About Ultibro Breezhaler
Ultibro Breezhaler 110/50 mcg is a once-daily LABA(+) /LAMA(++) dual
bronchodilator approved in the European Union (EU) as a maintenance
bronchodilator treatment to relieve symptoms in adult patients with
COPD[7]. Clinical trials have shown that it offers statistically
significant improvements in bronchodilation compared to treatments
widely used as current standards of care, including SFC 50/500 mcg[8],
[9],[10] and open-label tiotropium (18 mcg). Ultibro Breezhaler is
currently approved for use in over 80 countries worldwide, including
countries within the EU and Latin America, Japan, Canada, Switzerland
and Australia.
(+) a long-acting beta(2) -adrenergic agonist
(++) a long-acting muscarinic antagonist
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. The Novartis COPD portfolio includes Ultibro
Breezhaler (indacaterol/glycopyrronium bromide), Seebri(R) Breezhaler(R)
(glycopyrronium bromide) and Onbrez(R) Breezhaler(R) /Arcapta
Neohaler (indacaterol), which are all indicated as maintenance
treatments for COPD patients. Glycopyrronium bromide was exclusively
licensed to Novartis in April 2005 by Vectura and its co-development
partner Sosei.
Novartis continues development of respiratory products for delivery via
the low resistance Breezhaler(R) inhalation device, which makes it
suitable for patients with different severities of airflow
limitation[11]. The Breezhaler device allows patients to hear, feel and
see that they have taken the full dose correctly[7],[11].
About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated 210
million people worldwide[12] and is the third leading cause of
death[13]. It is progressive (usually gets worse over time), and can be
a life-threatening disease[14],[15]. COPD makes it difficult to breathe,
with symptoms that have a destructive impact on patients' function (i.e.
activity limitation, decreased mobility) and quality of life[14],[15].
Exacerbations (disease flare-ups) are a sudden worsening of COPD
symptoms that can be "frightening" for patients, causing distress,
anxiety and the deterioration of quality of life[16]. COPD exacerbations
are also associated with significant healthcare resource burden and
costs[17], particularly due to the frequent need for hospitalization.
Consequently, the prevention of exacerbations is an important goal in
COPD management to improve long-term health status and conserve
healthcare resources[18].
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "anticipated," "exploring," "committed,"
"continues," "can," "goal," or similar terms, or by express or implied
discussions regarding potential new indications or labeling for Ultibro
Breezhaler, or regarding potential future revenues from Ultibro
Breezhaler or any of the products in the Novartis COPD portfolio. You
should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from
those set forth in the forward-looking statements. There can be no
guarantee that Ultibro Breezhaler will be submitted or approved for any
additional indications or labeling in any market, or at any particular
time. Nor can there be any guarantee that any of the products in the
Novartis COPD portfolio will receive additional regulatory approvals or
be commercially successful in the future. In particular, management's
expectations regarding Ultibro Breezhaler or any of the other products
in the Novartis COPD portfolio could be affected by, among other things,
the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing
clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain
proprietary intellectual property protection; general economic and
industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing or quality
issues; unexpected safety issues, and other risks and factors referred
to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. 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 and cost-saving generic
pharmaceuticals. Novartis is the only global company with leading
positions in these areas. In 2015, the Group achieved net sales of USD
49.4 billion, while R&D throughout the Group amounted to approximately
USD 8.9 billion (USD 8.7 billion excluding impairment and amortization
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