Bli medlem
Bli medlem

Du är här

2015-05-20

Novartis International AG: Novartis announces two positive US phase III programs in COPD for QVA149 and NVA237

Novartis International AG / Novartis announces two positive US phase III
programs in COPD for QVA149 andNVA237 . Processed and transmitted by NASDAQ
OMX Corporate Solutions.The issuer is solely responsible for the content of
this announcement.
* QVA149 improved lung function, breathlessness and health-related quality of
life in moderate-to-severe COPD patients, according to EXPEDITION trial
results[1]-[7]

* GEM 1&2 studies showed NVA237 provided significant and clinically
meaningful improvements in lung function in moderate-to-severe COPD
patients[8],[9]

* In total, 26 Novartis abstracts presented at American Thoracic Society
(ATS) 2015; showcasing breadth of respiratory portfolio

Basel, May 20, 2015
-
Novartis announced today positive results from two pivotal Phase III clinical
trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237
(glycopyrronium bromide) in patients with moderate-to-severe chronic
obstructive pulmonary disease (COPD). The EXPEDITION (including FLIGHT 1, 2
and 3 studies) and GEM programs met their primary and secondary endpoints,
and the results were presented for the first time at the ATS International
Conference, May 15-20, 2015, in Denver, US[1]-[9].

Data from the EXPEDITION program demonstrated that QVA149, administered
twice-daily, improved lung function (FEV1AUC0-12h) compared to placebo and
its individual monocomponents, indacaterol and glycopyrronium bromide
(p<0.001), after 12 weeks of treatment, meeting its primary objective[1]-[2].
Further findings also confirmed that Novartis' dual bronchodilator improved
breathlessness, overall quality of life and COPD rescue medication
use[1]-[4]. It also showed significant improvements in FEV1at 5 min and 15
min compared to placebo according to new pooled data from over 2,000
patients[5].

"These data confirm that QVA149 significantly improves lung function,
breathlessness, and most importantly, overall quality of life", said Vasant
Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "With
millions of people in the US and around the world struggling to breathe due
to COPD, Novartis is committed to advancing QVA149 and other new medicines to
address this important unmet need".

In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated
significant and clinically meaningful improvements in lung function
(FEV1AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to
placebo (p<0.001); meeting its primary objective[8],[9]. Improvements in COPD
symptoms, quality of life and rescue medication use in patients with
moderate-to-severe airflow limitation were also observed[8],[9].

The safety profiles of QVA149, its monotherapy components and placebo were
broadly similar across the EXPEDITION studies[6],[7], as was NVA237 to
indacaterol and placebo in the GEM studies[8],[9].

There is an urgent need for new COPD treatments in the US as many people
remain symptomatic despite receiving medical care[10]. Reflecting this,
evidence from the EXPEDITION and GEM programs presented today has also been
used to support current QVA149 and NVA237 US regulatory submissions.

About EXPEDITION
The EXPEDITION program consisted of trials, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double-blind, parallel-group, placebo-and active-controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare QVA149 27.5/12.5 mcg, administered twice-daily, to its monotherapy components in terms of lung function (FEV1AUC0-12h) at week 12[1]-[4]. Breathlessness was measured by the transition dyspnea index (TDI) total score and overall quality of life by the St George's Respiratory Questionnaire (SGRQ) total score.FLIGHT 3 was a 52-week randomized, double-blind, parallel-group study to
assess the safety and tolerability of QVA149 27.5/12.5 mcg, administered
twice-daily, compared to once-daily indacaterol 75 mcg in moderate-to-severe
COPD patients. The primary endpoint was the overall rate of adverse events
reported during the study[7].

About GEM
GEM 1 and 2 were 12-week multi-center, randomized, double-blind,
placebo-controlled studies to assess the efficacy and safety of NVA237
(glycopyrronium bromide) 12.5 mcg, administered twice-daily, in
moderate-to-severe COPD patients. The primary objective was to compare NVA237
to placebo in terms of lung function (FEV1AUC0-12h) after 12 weeks of
treatment[8],[9].

About QVA149

QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, administered twice
daily, as used in the EXPEDITION program, has been submitted for US
registration. Outside of the US, QVA149 is marketed as Ultibro® Breezhaler®
110/50 mcg, which is a once-daily maintenance bronchodilator treatment to
relieve symptoms in adult patients with COPD11. Once-daily Ultibro Breezhaler
is currently approved for use in over 60 countries, including countries
within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About NVA237

NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, as used in
the GEM trials, has been submitted for US registration. Outside of the US,
NVA237 is marketed as Seebri® Breezhaler® 50 mcg, which is a once-daily
medication indicated as a maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD. Once-daily Seebri Breezhaler is
approved for use in over 80 countries, including countries within the EU and
Latin America, Japan, Canada, Switzerland and Australia[12].

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 QVA149/Ultibro Breezhaler
(indacaterol/glycopyrronium bromide), NVA237/Seebri Breezhaler
(glycopyrronium bromide) and Onbrez® Breezhaler®/Arcapta®Neohaler®
(indacaterol inhalation powder), 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.

Worldwide, 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[13]. The
Breezhaler device allows patients to hear, feel and see that they have taken
the full dose correctly[11],[13].

About COPD
COPD affects an estimated 210 million people worldwide[14] and nearly 27
million in the United States (US)[15]. It is a progressive lung condition
associated with chronic morbidity and mortality[14]. Deaths from COPD are
projected to increase over the next 10 years by more than 30% unless
underlying risk factors are addressed[16]. COPD is the third leading cause of
death in America, claiming the lives of 134,676 Americans in 2010[17], and is
expected to be the third leading cause of death worldwide by 2030[16].

COPD makes it difficult to breathe, with symptoms that have a destructive
impact on patients' ability to function and their quality of life[14],[18].
It is often considered to be a disease of later years, but estimates suggest
that 50% of those with COPD are now less than 65 years old, resulting in
increases in absenteeism, premature retirement and reductions in workforce
participation[19],[20].

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "committed," "continues," "projected,"
"expected," or similar terms, or by express or implied discussions regarding
potential marketing approvals for QVA149 and NVA237, or regarding potential
future revenues from QVA149, NVA237 and the other 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 QVA149 or NVA237
will be approved for sale in any markets where they have been submitted, or
will be submitted or approved for sale in any additional markets, or at any
particular time. Nor can there be any guarantee that QVA149, NVA237 and the
other products in the Novartis COPD portfolio will be commercially successful
in the future. In particular, management's expectations regarding QVA149,
NVA237 and the other products in the Novartis COPD portfolio could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; 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 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 2014, the Group
achieved net sales of USD 58.0 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 120,000 full-time-equivalent associates and sell products in
more than 150 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.

# # #

References

-------------------------------------------------------------------------------------------------------------------------------------
| [1] Kerwin EM, Fowler Taylor A, Ayers Tet al |
| . QVA149 imp...

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.