New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations
/www.w3.org/1999/xhtml'>New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations
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- BLAZE study showed once-daily QVA149 significantly improved patient self-reported shortness of breath and lung function compared to placebo and tiotropium 18 mcg[1]
- SPARK results showed that QVA149 significantly reduced rate of all exacerbations compared to glycopyrronium 50 mcg and open-label tiotropium 18 mcg[2],[3]
- Pooled GLOW 1 and 2 data showed once-daily Seebri® Breezhaler® (glycopyrronium) significantly improved lung function in the first 4 hours following morning administration compared to open-label tiotropium[4]
- COPD is projected to be the third leading cause of death by 2020[5]
Basel, May 21, 2013 - New data from the Novartis chronic obstructive pulmonary disease (COPD) portfolio were presented today at the American Thoracic Society (ATS) International Conference May 17-22, 2013 in Philadelphia, PA, USA. In total, Novartis presented 34 respiratory abstracts, featuring latest findings from the IGNITE clinical trial program including BLAZE[1] and SPARK[2],[3],[6],[7] studies, plus data from pooled GLOW1 and 2 studies[4],[8],[9],[10].
The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) when compared to placebo and blinded tiotropium 18 mcg[1]. The SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg[2],[3].
'The expanding Novartis COPD portfolio brings us another step closer to meeting the unmet needs of millions of patients worldwide,' said Tim Wright, Head of Development, Novartis Pharmaceuticals. 'These important results for both QVA149 and Seebri® Breezhaler® add further weight to our COPD portfolio, providing the right treatment for the right patient at the right time.'
COPD affects an estimated 210 million people worldwide[11] and is projected to be the third leading cause of death by 2020[5]. New treatments which effectively manage COPD are very important to patients and physicians, as COPD can impose a significant burden on patients and reduce quality of life[12],[13].
The BLAZE study showed that after six weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus both placebo (p1)at all time points (45 minutes pre-dose to four hours post-dose) after six weeks of treatment (p
The SPARK study, recently published in Lancet Respiratory Medicine[14], demonstrated that QVA149 significantly reduced the rate of all COPD exacerbations (mild, moderate and severe) by 15% versus glycopyrronium 50 mcg (p=0.0012) and 14% versus OL tiotropium 18 mcg (p=0.0017)[2],[3]. The primary endpoint of the study was also met since QVA149 demonstrated a significantly reduced rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038)[2],[3]. The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg[2],[3]. SPARK also showed that patients receiving QVA149 had substantially improved lung function (measured by trough FEV1)compared to glycopyrronium 50 mcg and OL tiotropium 18 mcg (both p
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as 'projected,' 'investigational,' 'committed,' 'ongoing,' 'continues' or similar expressions, or by express or implied discussions regarding potential approvals, or new indications or labeling for QVA149, Seebri Breezhaler and Onbrez Breezhaler, or regarding potential future revenues from such products. 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 QVA149 will be submitted or approved for sale in any market, or that Seebri Breezhaler or Onbrez Breezhaler will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that such products 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.
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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 129,000 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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