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      Chronic Obstructive Pulmonary Disease (COPD) Backgrounder

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  • May 21, 2014 07:15 AM WES

    Novartis announces positive results at ATS for once-daily Ultibro® Breezhaler® versus combination therapy (tiotropium plus formoterol)

    • QUANTIFY study met primary endpoint demonstrating non-inferiority of Ultibro® Breezhaler® vs tiotropium 18 mcg plus formoterol 12 mcg in improving health-related quality of life outcomes1,2 

    • QUANTIFY study met secondary endpoint demonstrating superiority of Ultibro Breezhaler vs tiotropium plus formoterol by improving lung function1,2 

    • Ultibro Breezhaler provides the convenience of a once-daily fixed-dose combination in a single inhalation device for the treatment of COPD

    • Novartis showcases 16 respiratory abstracts at the 2014 American Thoracic Society (ATS) International Conference

    Basel, May 21, 2014 – Novartis announced today new data from the QUANTIFY study, which demonstrated the non-inferiority of Ultibro® Breezhaler® (indacaterol/glycopyrronium) 110/50 mcg compared to tiotropium 18 mcg plus formoterol 12 mcg in terms of health-related quality of life (HRQoL) outcomes in moderate-to-severe chronic obstructive pulmonary disease (COPD) patients at week 261,2. Positive results from QUANTIFY are part of 16 Novartis respiratory abstracts being presented at the American Thoracic Society (ATS) International Conference, May 16-21, 2014 in San Diego, CA, USA.

    In the QUANTIFY study, which included over 900 COPD patients, once-daily Ultibro Breezhaler showed superior improvements in lung function (trough FEV1) at 26 weeks compared to once-daily tiotropium plus twice-daily formoterol in moderate-to-severe COPD patients. Additionally, patients taking Ultibro Breezhaler were more likely to demonstrate a clinically meaningful improvement in shortness of breath and health-related quality of life (per protocol set) at 26 weeks compared to tiotropium plus formoterol. The safety and tolerability of Ultibro Breezhaler was comparable to the other treatment arm in the study1,2.

    “These positive results from QUANTIFY demonstrate that once-daily Ultibro Breezhaler can provide better symptom control versus a combination of two individual treatments, tiotropium plus formoterol,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals.
    More patients on Ultibro Breezhaler had a meaningful improvement in health-related quality of life demonstrating superiority of our LABA/LAMA vs tiotropium plus formoterol.”

    COPD affects an estimated 210 million people worldwide
    3 and is projected to be the third leading cause of death by 20204. Symptoms can impose a significant burden on patients and reduce quality of life5,6, but they are often inadequately managed. Treatments that are easy for patients to take and have reliable dose control whilst effectively managing the symptoms of COPD are important to improve patient outcomes7-9.

    QUANTIFY was a 26-week treatment, multicenter, randomized, parallel group, blinded study to assess the efficacy and safety of once-daily Ultibro Breezhaler in 934 patients with moderate-to-severe COPD, versus the free-combination of tiotropium 18 mcg plus formoterol 12 mcg. The primary objective 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. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability1,2.

  • Full Press Release

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.


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