Du är här

2016-05-15

Novartis International AG: Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations

Novartis International AG / Major study published in NEJM confirms Novartis'
Ultibro® Breezhaler®superiority over Seretide® 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®Breezhaler®over
Seretide ®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:

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®Breezhaler®(indacaterol/glycopyrronium bromide) 110/50 mcg to
twice-daily Seretide®(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 beta2-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 beta2-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®Breezhaler®(glycopyrronium
bromide) and Onbrez®Breezhaler®/ArcaptaTMNeohalerTM(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®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 charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

For Novartis multimedia content, please
visitwww.novartis.com/news/media-library. For questions about the site or
required registration, please contact:media.relations@novartis.com

References

---------------------------------------------------------------------------------------------------------
| [1] Wedzicha JA, Banerji D, Chapman KR,et al |
| . Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone for COPD |
| Exacerbations. |
| New England Journal of Medicine |
| . 2016. Available at:www.nejm.org/doi/full/10.1056/NEJMoa1516385[Accessed 15 |
| May 2016]. ...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.