Novartis showcases 39 abstracts highlighting robust respiratory portfolio at ERS 2013
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Novartis showcases 39 abstracts highlighting robust respiratory portfolio at ERS
2013
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* Robust efficacy of once-daily Ultibro(®) Breezhaler(®) (QVA149) supported by
a pooled analysis of the Phase III IGNITE clinical trial program further
strengthens evidence for the Ultibro(®) LABA+LAMA combination for the
treatment of COPD patients[1],[2],[3]
* Once-daily Seebri(® ) Breezhaler(® )(glycopyrronium) efficacy data
strengthened by new analyses from the SPARK study on exacerbations and lung
function in severe and very severe COPD patients[4],[5]
* First data on investigational QGE031, a new, high-affinity anti-IGE therapy
for severe allergic diseases[6]
Basel, September 4, 2013 - New data to be presented from the Novartis
respiratory portfolio at the European Respiratory Society (ERS) Annual Congress
2013 in Barcelona, Spain, further demonstrates Novartis' commitment to providing
treatment options for patients with chronic obstructive pulmonary disease (COPD)
or severe allergic asthma (SAA).
"Patients with COPD or severe allergic asthma, and the healthcare professionals
that treat them, need effective treatment choices. Novartis is committed to
providing a broad range of options to help reduce the significant burden of
respiratory disease", commented Tim Wright, Head of Development, Novartis
Pharmaceuticals. "Novartis is very excited to be sharing important new data at
ERS to further demonstrate the strength of our expanding respiratory portfolio
and continued commitment to this therapeutic area."
Data presented at ERS include the latest analyses from the Phase III IGNITE
clinical trial program on Ultibro(®) Breezhaler(®) (QVA149 - indacaterol 85
mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered
dose per capsule)[1],[2],[3]. QVA149 is a once-daily investigational fixed dose
combination of a long-acting beta(2)-adrenergic agonist (LABA) and a long-acting
muscarinic antagonist (LAMA), that received a positive opinion for approval from
the European Medicine Agency's (EMA) Committee for the Human use of Medicinal
Products (CHMP) in July 2013 as a maintenance bronchodilator treatment to
relieve symptoms in adult patients with COPD.
New exacerbation, lung function and safety data will also be presented on
Seebri(®) Breezhaler(®) (glycopyrronium 44 mcg delivered dose equivalent to 50
mcg metered dose per capsule)[4],[5], and efficacy data on Onbrez(®)
Breezhaler(®) (indacaterol maleate 150 mcg)[7], which are the monotherapy
components of QVA149.
In severe allergic asthma, new data will be presented on Xolair(®) (omalizumab),
an anti-IgE monoclonal antibody indicated as an add-on therapy for patients with
uncontrolled severe allergic (IgE-mediated) asthma. It is well recognized that
omalizumab can significantly reduce the risk of exacerbations in patients with
severe allergic asthma and new studies are helping to better understand its
effects on the processes that underlie the disease.
New clinical data relating to investigational QGE031 will be presented for the
first time at ERS. QGE031 is a humanized anti-Immunoglobulin E monoclonal
antibody in development for the treatment of IgE-driven diseases where a
significant unmet need exists such as severe uncontrolled asthma, atopic
dermatitis (AD) and food allergies[6].
+-------------------------------------------+-------------+--------------------+
| |Lead Author |Presentation Details|
| Key Novartis ERS Abstract Presentations | | |
+-------------------------------------------+-------------+--------------------+
|COPD |
+-------------------------------------------+-------------+--------------------+
|851270 |J. Wedzicha |Oral presentation |
|Once-daily glycopyrronium improves lung | |September 8 |
|function and reduces exacerbations in | |08:30 - 10:30 |
|severe-to-very severe COPD | |Room 2.4 |
|patients: The SPARK study[4] | | |
+-------------------------------------------+-------------+--------------------+
|851178 |C. Vogelmeier|Thematic poster |
|Once-daily QVA149 provides clinically | |September 8 |
|meaningful improvements in lung function | |12:50 - 14:40 |
|and clinical outcomes[1] | |HALL 1-10 |
+-------------------------------------------+-------------+--------------------+
|851279 |M. Decramer |Poster discussion |
|Safety of once-daily glycopyrronium in | |September 10 |
|patients with severe-to-very severe COPD: | |08:30 - 10:30 |
|The SPARK study[5] | |Room 3.5 |
+-------------------------------------------+-------------+--------------------+
|851388 |D. Banerji |Poster discussion |
|Dual bronchodilation with once-daily QVA149| |September 10 |
|improves dyspnea and health status and | |08:30 - 10:30 |
|reduces symptoms and rescue medication use | |Room 3.5 |
|in patients with COPD: the IGNITE trials[2]| | |
+-------------------------------------------+-------------+--------------------+
|851415 |D. Banerji |Poster discussion |
|Dual bronchodilation with once-daily QVA149| |September 10 |
|improves lung function and reduces | |08:30 - 10:30 |
|exacerbations in patients with COPD: the | |Room 3.5 |
|IGNITE trials[3] | | |
+-------------------------------------------+-------------+--------------------+
|851296 |D. Mahler |Poster discussion |
|Patients with severe COPD show significant | |September 10 |
|improvements in dyspnea and lung function | |08:30 - 10:30 |
|with once-daily QVA149: the BLAZE study[8] | |Room 3.5 |
+-------------------------------------------+-------------+--------------------+
|851282 |J. Ficker |Poster discussion |
|QVA149 improves lung function and reduces | |September 10 |
|exacerbations compared to tiotropium in | |10:45 - 12:45 |
|patients with severe-to-very severe COPD: | |Room 3.8 |
|the SPARK study[9] | | |
+-------------------------------------------+-------------+--------------------+
Alongside abstract presentations, Novartis will also be holding the following
three symposia at ERS:
* Rethinking the treatment landscape of COPD: September 8 (17:15-19:15 CET,
Room 3.13)
* The omalizumab story: Past, present and future: September 8 (17:15-19:15
CET, Room 3.12)
* Dual bronchodilation: A new treatment option for COPD patients: September 9
(17:15-19:15 CET, Room 3.13)
ERS is the largest respiratory meeting in the world, with delegates attending
from more than 100 countries. All abstracts and details on timings can be
accessed through the ERS website: http://www.erscongress2013.org.
About the Novartis respiratory portfolio
Novartis is committed to addressing the unmet medical needs of patients with
respiratory diseases and improving their quality of life by providing innovative
medicines and devices. In addition, the company is currently conducting more
than 145 sponsor-led clinical trials involving more than 140,000 patients in
support of regulatory submissions for new respiratory medicines. Novartis is
consistently rated as having one of the industry's most respected pharmaceutical
development pipelines with more than 140 projects in pharmaceutical clinical
development.
Onbrez(®) Breezhaler(® )(indacaterol maleate) is a long-acting beta(2)-
adrenergic agonist (LABA) that offers clinically relevant 24-hour
bronchodilation combined with a rapid onset of action within five minutes at
first dose, as demonstrated in the INERGIZE Phase III trial program[10]-[24].
Onbrez Breezhaler 150 mcg once-daily provided greater clinical benefit in terms
of reduced shortness of breath, lower use of rescue medication and improved
health status, compared with blinded tiotropium bromide 18 mcg in patients with
moderate-to-severe COPD[21]. Onbrez Breezhaleris approved in approximately 100
countries around the world for maintenance bronchodilator treatment of airflow
obstruction in adult patients with COPD[25]. It was first launched in the EU
(150 mcg and 300 mcg once-daily doses) and has since received approvals in
markets worldwide including Japan (Onbrez(® )Inhalation Capsules 150 mcg once-
daily) and US (Arcapta(TM) Neohaler(TM )75 mcg once-daily).
Once-daily Seebri(®) Breezhaler(®) (glycopyrronium bromide) is a novel inhaled
long-acting muscarinic antagonist (LAMA; also referred to as a long-acting
anticholinergic) indicated as a maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD[26]. Glycopyrronium bromide was exclusively
licensed to Novartis in April 2005 by Vectura and its co-development partner
Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that
glycopyrronium 50 mcg delivered rapid and significant sustained improvements in
lung function (measured by mean FEV(1)) from Day 1 compared with placebo and
sustained this for 24 hours over 52 weeks, and significantly improved exercise
endurance versus placebo[27],[28],[29]. Seebri Breezhaler is approved in the
EU/EEA, Japan, Switzerland, Canada, Australia and a number of other countries.
QVA149 is an investigational inhaled, once-daily, fixed-dose combination of
indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for
the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is
one of the largest international clinical trial programs in COPD comprising 11
studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE,
BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52
countries[30]-[42]. The first eight studies (ILLUMINATE, SHINE, BRIGHT,
ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies are
designed to investigate efficacy, safety and tolerability, lung function,
exercise endurance, exacerbations, shortness of breath and quality of life of
patients treated with QVA149.
Results from the Phase III IGNITE trials[30]-[38],[42] demonstrated
statistically significant improvements in bronchodilation with QVA149 versus
certain treatments widely used as current standards of care[43]. Data showed
that QVA149 significantly improved bronchodilation compared to open-label (OL)
tiotropium 18 mcg, salmeterol/fluticasone fixed dose combination (SFC) 50
mcg/500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo
providing a rapid onset within five minutes, and sustained bronchodilation
during a 24 hour period which was maintained for up to 26 weeks. In the IGNITE
phase III trial program, QVA149 also showed symptomatic improvements versus
placebo in COPD patients[31],[33],[34],[43]. These symptomatic improvements
included breathlessness, exercise tolerance, rescue medication use and health-
related quality of life[31],[33],[34],[43].
In clinical studies, QVA149 demonstrated an acceptable safety profile with no
meaningful differences between the treatment groups (placebo, indacaterol 150
mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, SFC 50 mcg/500 mcg) in the
incidence of adverse and serious adverse events[30],[31],[33],[34],[44].
Novartis continues development of respiratory products for delivery via a
platform called the Breezhaler(®) device. This is a single-dose dry powder
inhaler (SDDPI), which has low air flow resistance, making it suitable for
patients with different severity of airflow limitation[45]. The Breezhaler(®)
device allows patients to hear, feel and see that they have taken the full dose
correctly[26].
In 2003, the US Food and Drug Administration (FDA) approved Xolair(®
)(omalizumab), an injectable therapy, for the treatment of patients 12 years of
age and older with moderate-to-severe persistent allergic asthma that is
inadequately controlled with inhaled corticosteroids[46]. In 2005, the Committee
for Medicinal Products for Human Use (CHMP) gave a positive opinion on the
marketing authorization for Xolair for the treatment of severe persistent
allergic asthma in adults and adolescents (>=12 years of age)[47], who have
multiple severe asthma exacerbations despite daily high dose inhaled
corticosteroids plus a long acting beta agonist. This was followed by the
European Commission granting marketing authorization for all 25 EU member
states[47]. In 2009, Novartis also received marketing approval for Xolair in the
EU as an add on therapy to high dose inhaled corticosteroid (ICS) plus a LABA,
to treat children aged 6 to <12 years with severe persistent allergic
asthma[48].
Xolair is a humanized monoclonal antibody that blocks the action of
immunoglobulin E (IgE), an antibody involved in the underlying mechanism of
allergic asthma. In three pivotal trials[49],[50],[51]involving 482, 525 and
546 patients respectively, by targeting IgE, Xolair was shown to significantly
decrease the incidence of asthma exacerbations in severely affected patients
when added to an ICS and LABA[49],[50],[51]. Novartis co-promotes Xolair with
Genentech/Roche in the US and shares a portion of the operating income, but does
not book US sales.
*Total refers to all 11 IGNITE studies.
About COPD
COPD is a progressive life-threatening disease that makes it hard to breathe,
with symptoms that have a destructive impact on patients' function and quality
of life[52],[53]. It affects an estimated 210 million people worldwide[54] and
is projected to be the third leading cause of death by 2020[52]. COPD 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[55].
About severe allergic asthma
Asthma is a chronic, inflammatory lung disease that is often triggered by
allergies. Asthma is characterized by airway obstruction, resulting in the
symptoms of chest tightness, wheezing and coughing[56].
Asthma affects around 300 million people globally[57] and is one of the most
common chronic diseases among children[58]. For an estimated 5-8% of patients,
symptoms are more severe[59]. A proportion of asthmatic patients have their
symptoms triggered when exposed to everyday allergens such as dust and mould -
these patients have allergic asthma[57],[59].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "showcases," "investigational," "will," "commitment," "to
be presented," "committed," "to be sharing," "expanding," "positive opinion,"
"in development," "continues," "projected," "is being investigated," "designed
to," "continues development," or similar expressions, or by express or implied
discussions regarding potential marketing approvals for Ultibro Breezhaler or
QGE031, or regarding potential future revenues from Ultibro Breezhaler, Seebri
Breezhaler, Onbrez Breezhaler, Xolair or QGE031. 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 to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Ultibro
Breezhaler or QGE031 will be approved for sale in any market, or at any
particular time. There can be no guarantee that Seebri Breezhaler, Onbrez
Breezhaler or Xolair will be approved for any additional indications or labeling
in any market, or at any particular time. Nor can there be any guarantee that
Ultibro Breezhaler, Seebri Breezhaler, Onbrez Breezhaler, Xolair or QGE031 will
achieve any particular levels of revenue in the future. In particular,
management's expectations regarding such products 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;
unexpected manufacturing issues; 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 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, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
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