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Novartis to unveil new data from three key clinical trials at European Respiratory Society International Congress 2014


September 2, 2014 - London

Novartis International AG /Novartis to unveil new data from three key clinical trials at European Respiratory Society International Congress 2014 . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

  • First presentation of LANTERN study to confirm superior efficacy of once-daily Ultibro® Breezhaler® versus Seretide® Accuhaler®* in COPD patients[1]
     
  • QUANTIFY study to show superiority of Ultibro Breezhaler in lung function and shortness of breath versus tiotropium plus formoterol[2]
     
  • New data from GLISTEN study will provide important evidence for the benefits of once-daily Seebri® Breezhaler® as add on therapy to LABA/ICS**[3]

Basel, September 2, 2014 - Novartis announced today that a wealth of new data from its respiratory portfolio will be presented at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany. In total, 44 abstracts (including four late-breakers) will be presented by Novartis, representing more than any other company at the congress.

"Novartis is committed to making a difference to the lives of millions of people worldwide living with debilitating conditions, such as COPD and severe asthma," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "We hear from patients how their lives have improved because of our respiratory medicines, and this motivates us to continue to advance respiratory treatments in our portfolio."

Positive new results from the Phase III head-to-head LANTERN study showed the superiority of once-daily, dual bronchodilator, Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) in improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone combination: LABA/ICS**), in patients with moderate-to-severe COPD[1].

Analyses from the QUANTIFY study demonstrated that Ultibro Breezhaler significantly improved lung function and shortness of breath in patients with moderate-to-severe COPD, compared to the combination of tiotropium plus formoterol[2]. Results also showed that Ultibro Breezhaler is comparable to tiotropium plus formoterol in improving health-related quality of life[2].

Data from the GLISTEN trial showed that Seebri® Breezhaler® (glycopyrronium bromide) when added to LABA/ICS provided significant improvements in lung function, health status and rescue medication use in moderate-to-severe COPD patients when compared to LABA/ICS alone[3]. This study provides much-needed evidence for add-on therapy to LABA/ICS in COPD, to support physicians care choices where very little data exist[3].

The safety profiles of Ultibro Breezhaler and Seebri Breezhaler were similar to those of their respective study comparators in the LANTERN, QUANTIFY and GLISTEN studies[1],[2],[3].

Novartis events at ERS 2014:
Alongside abstract presentations at ERS 2014, Novartis is hosting a media briefing on September 7 (13.10-15.30 CET, Industry press briefing room, ERS Media Centre) and will be holding the following symposia:

  • Severe asthma symposium: There's more to IgE - Let's talk severe asthma: September 7 (17:15-19:15 CET, Auditorium)
  • COPD morning symposium: COPD exacerbations: from context to evidence to practice: September 8 (07:00-08:15 CET, Room 14C)
  • COPD evening symposium: COPD patients' needs and current treatment options: September 8 (17:15-19:15 CET, Auditorium)
     

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.erscongress.org. Novartis is sponsoring the official ERS Congress app enabling users to access the full congress program on their smartphones. Further information on the app can be found at: erscongress.org/mobile.

Key Novartis ERS Abstract Presentations Lead Authors Presentation Details
850533
Once-daily QVA149 improves lung function and dyspnoea compared
with tiotropium plus formoterol: the QUANTIFY study
S. Korn Poster Discussion
September 7
12:50-14:40
Hall B2-21
700090
Efficacy and safety of once-daily QVA149 compared with twice-daily
salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study
N. Zhong Poster Session
September 8
12:50-14:40
Hall B2-43
700128
Glycopyrronium once-daily significantly improves lung function
and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study
P. Frith Poster Session
September 8
12:50-14:40
Hall B2-43
854774
Morning symptoms and acute
breathing difficulties in the diagnosis of COPD
P. O'Hagan Poster Session
September 9
12:50-14:40
Hall B2-16

About the LANTERN Study
The primary objective of the LANTERN study was to demonstrate the non-inferiority of Ultibro Breezhaler to SFC in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year[1].

About the QUANTIFY Study
The primary objective of QUANTIFY was to demonstrate non-inferiority of Ultibro Breezhaler in HRQoL, as assessed by the St. George's Respiratory Questionnaire-COPD (SGRQ-C), versus tiotropium plus formoterol after 26 weeks of treatment in patients with moderate-to-severe COPD2. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability[2].

About the GLISTEN Study
The primary objective of GLISTEN was to demonstrate non-inferiority of Seebri Breezhaler 50 mcg versus tiotropium 18 mcg when added to salmeterol/fluticasone 50/500 mcg on trough FEV1 after 12 weeks of treatment in patients with moderate-to-severe COPD[3]. The secondary endpoints included comparison of Seebri Breezhaler 50 mcg added to salmeterol/fluticasone compared with salmeterol/fluticasone plus placebo[3].

About Novartis in Respiratory
Novartis is committed to addressing the unmet medical needs of COPD and severe asthma patients and improving their quality of life by providing innovative medicines and devices. The Novartis respiratory portfolio includes Ultibro Breezhaler (indacaterol/ glycopyrronium bromide), Seebri Breezhaler (glycopyrronium bromide) and Onbrez® Breezhaler®/ArcaptaTM NeohalerTM (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[4]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[4],[5].

In addition, the portfolio also includes Xolair® for the treatment of severe persistent allergic asthma[6],[7]. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "to unveil," "to confirm," "to show," "will," "committed," "continue," "to support," "continues," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Ultibro Breezhaler and Seebri Breezhaler, or regarding potential future revenues from any or all of the products in the Novartis respiratory portfolio, including Ultibro Breezhaler and Seebri Breezhaler. 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 or Seebri 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 respiratory portfolio will receive additional regulatory approvals or be commercially successful in the future. In particular, management's expectations regarding these products 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 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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 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 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

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

*The LANTERN study used Seretide® (salmeterol/fluticasone) 50/500 mcg, which is indicated in the UK for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy[8]. The patient population in the LANTERN study were stable moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. Seretide® is also known as Advair®, and Accuhaler® is also known as Diskus®. Seretide®, Advair®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies.

**LABA (long-acting beta agonist); ICS (inhaled corticosteroid)

References
[1] Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281; Date: September 8, 2014 Time: 12:50-14:40].
[2] Korn S et al. Once-daily QVA149 improves lung function and dyspnoea compared with tiotropium plus formoterol: the QUANTIFY study [ERS abstract 850533; Session 101; Date: September 7, 2014 Time: 12:50-14:40].
[3] Frith P et al. Glycopyrronium once-daily significantly improves lung function and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study. [ERS abstract 700128; Session 281; September 8, 2014 Time: 12:50-14:40].
[4] Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010;26; 11:2527-2533. doi:10.1185/03007995.2010.518916.
[5] Ultibro Breezhaler EU Summary of Product Characteristics. [Online]. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002679/WC500151255.pdf. [Accessed 1 August 2014]
[6] Xolair US Prescribing Information. 2003. 
[7] European Medicines Agency. Xolair EPAR summary for the public. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000606/WC500057293.pdf. [Accessed 2 August 2014].
[8] Seretide® Summary of Product Characteristics [Online] Available at: https://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler [Accessed 1 August 2014]

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