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May 20, 2009

Phase III data showed Novartis investigational bronchodilator QAB149 significantly improved lung function in COPD patients

• QAB149 (indacaterol) significantly improved lung function compared to placebo at 12 weeks in three phase III studies
• Given once daily, QAB149 showed clinically relevant 24-hour bronchodilation and onset of action within five minutes
• In a 52-week study, QAB149 increased lung function compared to twice-daily formoterol from day one through one year of treatment (exploratory endpoints)
• COPD is a progressive, life-threatening respiratory disease that affects 210 million people worldwide

East Hanover, NJ, May 20, 2009 - The Novartis investigational bronchodilator QAB149 (indacaterol) met the primary efficacy endpoints of improved lung function compared to placebo at 12 weeks in three pivotal phase III studies in chronic obstructive pulmonary disease (COPD) patients. In secondary endpoints of these studies, QAB149 demonstrated clinically relevant* lung function improvements within five minutes of the first dose, lasting for 24 hours in COPD patients.

The QAB149 data, which were presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego, are the first from the Phase III INVOLVE†, INHANCE‡ and INLIGHT-1§ trials. These were three multinational, multi-center, randomized, double-blind, placebo-controlled studies in over 3,800 patients with moderate-to-severe COPD.

"Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD."

In the six-month INHANCE trial, QAB149 150µg and 300µg doses significantly improved lung function at 12 weeks compared to placebo. Improvements [measured by difference in trough forced expiratory volume in one second (FEV1)] were observed after one day (110mL and 140mL), at the 12 week primary endpoint (both doses 180mL), and at 26 weeks (160mL and 180mL). Results were statistically significant (p<0.001) for each of the doses compared to placebo at each of these time points.

In the one-year INVOLVE trial, which compared QAB149 (300µg and 600µg doses) and formoterol (12µg dose) with placebo, QAB149 improved symptom control (cough, wheezing, breathlessness, sputum production and color), nights free of awakening and days able to perform usual activities over placebo (secondary endpoints). Both doses of QAB149 demonstrated improvements over twice-daily formoterol in trough FEV1) difference versus placebo after one day (140mL and 170mL vs. 110mL; p<0.05), at 12 weeks (170mL and 170mL vs. 70mL; p<0.001) and at one year (160mL and 150mL vs. 50mL; p<0.001) in exploratory endpoints. Both QAB149 doses and formoterol prolonged the time to first COPD flare-up (exacerbation) compared to placebo [hazard ratios of 0.77 (p=0.030), 0.69 (p=0.003) and 0.77 (p=0.034), respectively].

COPD is a progressive, life-threatening respiratory disease that affects 210 million people worldwide. Commonly caused by cigarette smoke and other harmful fumes, COPD is characterized by a persistent obstruction of airflow from the lungs. While COPD is incurable, improved airflow with the use of long-acting bronchodilators is central to symptom management. According to the World Health Organization, unless urgent action is taken to reduce the risk factors, COPD is projected to become the third leading cause of death worldwide by 2030.

"Novartis is committed to developing a range of therapies for patients with respiratory diseases such as COPD," said John Orloff, M.D., Senior Vice President, US Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation. "QAB149 could become the foundation for a portfolio of medicines currently in development designed to address unmet needs in respiratory care."

QAB149 given once daily is being investigated for the treatment of COPD. It is not being developed as a single-agent treatment for asthma. QAB149 belongs to a class of medications known as long-acting beta2-agonists or LABAs. In patients with asthma, LABAs may increase the chance of asthma-related death.

In clinical studies, the most commonly reported adverse reactions with QAB149 were nasopharyngitis, upper respiratory tract infection, cough, and headache.

QAB149 is currently undergoing regulatory review in the European Union and the United States.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "projected," "developing," "could," "in development designed to," or similar expressions, or by express or implied discussions regarding potential marketing approvals for QAB149 or of a potential Novartis portfolio of respiratory products 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 the Company 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 QAB149 or any other potential components of a Novartis portfolio of respiratory products will be approved for sale 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 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; 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 Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

* Defined as >120mL more than placebo in forced expiratory volume in one second (FEV1), a standard measure of lung function
‡INHANCE = Indacaterol: vs tiotropium to help achieve new COPD treatment excellence
†INVOLVE = Indacaterol: value in COPD pulmonary disease: longer-term validation of efficacy and safety
INLIGHT-1§ = Indacaterol: efficacy evaluation using 150µg doses with COPD patients

References

1 Dahl R, et al. "Indacaterol Once-daily Provides 24-h Bronchodilation over 52 Weeks of Treatment in COPD." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

2 Fogarty C, et al. "Sustained 24-h Bronchodilation with QAB149 Once-Daily in COPD: A 26-Week Efficacy and Safety Study." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

3 Siler T, et al. "Efficacy and Safety of Indacaterol 150 µg Once-daily in COPD: 1 12-week Study." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

4 Paggiaro P, et al. "Bronchodilator Treatment with Indacaterol Once-daily vs Formoterol Twice-daily in COPD: a 52-week study." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

5 World Health Organization. Factsheet No 315 Chronic obstructive pulmonary disease (COPD).
http://www.who.int/mediacentre/factsheets/fs315/en/index.html (accessed 10 April 2009).

6 Novartis data on file.

7 Nonikov V, et al. "Indacaterol Once-daily Reduces Days of Poor Control in COPD Over 52 Weeks of Treatment." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

8 Buhl R, et al. "Indacaterol once-daily reduces COPD exacerbations over 52 weeks of treatment." Poster presented at American Thoracic Society (ATS) 2009 International Conference, May 2009.

9 NHBLI. What is COPD? http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html (accessed 10 April 2009).

10 Global Initiative for Chronic Obstructive Pulmonary Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Lung Disease. Updated 2007.

11 Food and Drug Administration. FDA Public Health Advisory: Serevent Diskus, Advair Diskus (fluticasone propionate, Foradil Aerolizer. http://www.fda.gov/CDER/Drug/advisory/LABA.htm (accessed 1 April 2009).

 

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