Novartis QVA149 Phase III COPD studies meet primary endpoints
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Novartis QVA149 Phase III COPD studies meet primary endpoints
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* QVA149 efficacy, safety and exercise endurance primary endpoints all
met[1],[2],[3]
* Studies are part of IGNITE Phase III clinical trial program intended to form
the basis for an NDA filing in COPD
* QVA149, a bronchodilator with dual mode of action, is Novartis' third
innovation in its Breezhaler(®) Single Dose Dry Powder Inhaler
* COPD is predicted to be the third leading cause of death in the world by
2020[4]
Basel, April 2, 2012 - The first three Novartis QVA149 Phase III studies in the
treatment of chronic obstructive pulmonary disease (COPD) all met their primary
endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of
the IGNITE program, demonstrate the potential of QVA149 in the treatment of
COPD.
The results of SHINE, with an enrollment of more than 2,100 patients, met the
primary endpoint by demonstrating the superiority in trough FEV(1 )(p<0.001) of
once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in
patients with moderate to severe COPD[1](. )In addition, QVA149 showed
superiority in trough FEV(1 )(p<0.001) compared to placebo and open-label
tiotropium (18 mcg).
The results of BRIGHT demonstrated that patients experienced significantly
better exercise endurance versus placebo (p=0.006)[3]. ENLIGHTEN demonstrated
that QVA149 was well tolerated with a safety and tolerability profile similar to
placebo[2].
"Meeting the primary endpoints in the IGNITE Phase III clinical trial program
signals significant progress in establishing the potential of QVA149, which is
expected to be the third innovative medicine in our strong COPD portfolio," said
Tim Wright, Head of Development, Novartis Pharmaceuticals. "Novartis is
committed to addressing the unmet needs of COPD patients and improving their
quality of life by providing innovative medicines and devices."
QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational
inhaled, once-daily, fixed dose combination of the long acting beta(2)-agonist
(LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA)
glycopyrronium bromide (NVA237). Data from the IGNITE clinical trial program
examining QVA149 in a number of settings will be submitted for presentation to a
major medical congress later this year.
IGNITE is one of the largest international patient registration programs in COPD
comprising 10 studies in total. The first seven studies (ENLIGHTEN, BRIGHT,
SHINE, ILLUMINATE, SPARK, BLAZE, ARISE) are expected to complete in 2012 and
include more than 5,700 patients across 42 countries and support planned filings
in the EU and Japan. Included in the program is a head-to-head trial vs
Seretide(®)[5] (ILLUMINATE), which is also expected to complete during the
second quarter of 2012 and will be incorporated into regulatory filings. These
studies are designed to investigate efficacy, safety and tolerability, lung
function, exercise endurance, exacerbations, dyspnea and quality of life.
SHINE is a 26-week, multicenter, randomized, double-blind, parallel-group,
placebo and active controlled pivotal trial of 2,144 patients with moderate to
severe COPD to assess efficacy in terms of trough FEV(1). BRIGHT is a three-
week, randomized, blinded, double-dummy, multi-center, placebo controlled,
three-period crossover pivotal trial of 85 patients with moderate or severe COPD
to assess the effect on exercise tolerance of QVA149. ENLIGHTEN is a 52-week,
multicenter, randomized, double-blind, parallel-group, placebo controlled
pivotal trial of 339 patients with moderate or severe COPD to assess the safety
and tolerability of QVA149.
COPD is a progressive disease associated mainly with tobacco smoking, air
pollution or occupational exposure, which can cause obstruction of airflow in
the lungs resulting in debilitating bouts of breathlessness. It affects an
estimated 210 million people worldwide[6] and is predicted to be the third
leading cause of death by 2020[4]. Although COPD is often thought of as a
disease of the elderly, 50% of patients are estimated to be within the ages of
50 and 65, which means that half of the COPD population are likely to be
impacted at the peak of their earning power and family responsibilities[7].
QVA149 would be the third innovation in the Novartis COPD portfolio to be
delivered using the Breezhaler(®) Single Dose Dry Powder Inhaler, along with
Onbrez(®) Breezhaler(®) (indacaterol) and investigational Seebri(®
)Breezhaler(®) (glycopyrronium bromide/NVA237).
Onbrez(®) Breezhaler(® )(indacaterol maleate) is the only COPD treatment to
offer clinically relevant 24-hour bronchodilation combined with a rapid onset of
action at first dose and has shown significant symptomatic improvement
especially on breathlessness[8]. In March 2012, Novartis launched the 75 mcg
once-daily dose in the US under the brand name Arcapta(TM) Neohaler(TM). It is
also available as a 150 mcg once-daily dose in Japan under the brand name
Onbrez(®) Inhalation Capsules.
Seebri(®) Breezhaler(®) (glycopyrronium bromide/NVA237) is an investigational
long-acting muscarinic antagonist (LAMA) developed as a once-daily inhaled
maintenance therapy for the treatment of COPD. Phase III data from the GLOW
1, 2 and 3 studies demonstrated that Seebri increased patients' lung function
over a 24-hour period compared to placebo with a fast onset of action at first
dose, as well as improving exercise endurance. Glycopyrronium bromide (Seebri(®)
Breezhaler(®)) was licensed to Novartis in April 2005 by Vectura and its co-
development partner Sosei, and was submitted for regulatory approval in Europe
in Q3 2011 and Japan in Q4 2011.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "intended," "predicted," "potential," "expected,"
"commited," "will," "planned," "designed to," or similar expressions, or by
express or implied discussions regarding potential marketing submissions or
approvals for QVA149 and Seebri Breezhaler, or regarding the timing of any such
submissions or approvals, or regarding potential future revenues from QVA149,
Onbrez Breezhaler and Seebri 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 these
products to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that QVA149 or Seebri Breezhaler will be submitted or approved for sale in any
market, or that any such submissions or approvals will happen at any particular
time. Nor can there be any guarantee that QVA149, Onbrez Breezhaler, or Seebri
Breezhaler will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding these products could be affected
by, among other things, unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally;
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 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
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References
[1] QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG. ClinicalTrials.gov
identifier: NCT01202188.
[2] QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG.
ClinicalTrials.gov identifier: NCT01120717.
[3] QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG. ClinicalTrials.gov
identifier: NCT01294787.
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2011.
http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf Last
accessed 23 March 2012.
[5] Seretide is a registered trademark of GSK
[6] Global Alliance against Chronic Respiratory Diseases (GARD). Global
surveillance, prevention and control of chronic respiratory diseases: a
comprehensive approach. Available at:
http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 23
March 2012.
[7] Fletcher, M, et al. COPD Uncovered: An International survey on the impact
of chronic obstructive pulmonary disease (COPD) on a working age population. BMC
Public Health 2011, 11:612.
[8] Onbrez(®) Breezhaler(® )(indacaterol)EU Summary of Product Characteristics
May 31, 2011
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/0011
14/human_med_001219.jsp&mid=WC0b01ac058001d124
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Datum: 02.04.2012 - 07:15 Uhr
Sprache: Deutsch
News-ID 130705
Anzahl Zeichen: 14349
contact information:
Town:
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