Jan 05, 2016
  • The Breezhaler(TM) inhaler is the device for Novartis' portfolio of COPD treatments of Onbrez and Seebri, and Ultibro, the leading LABA/LAMA treatment
  • The collaboration further supports Novartis' focus to empower patients making it easier for them to manage their own chronic disease by having near real time access to their own data on inhalation use
  • Novartis plans to launch the next generation connected Breezhaler(TM) in 2019

Basel, January 5, 2016 - Novartis announced today a collaboration with Qualcomm Incorporated through its subsidiary, Qualcomm Life, Inc., in digital innovation with the Breezhaler(TM) inhaler device to treat COPD. Under this collaboration, Qualcomm Life will provide the technology solution for the connectivity of the next generation of the Breezhaler(TM) inhaler, a device used for Novartis' portfolio of COPD treatments of Onbrez(TM) Breezhaler Seebri(TM) Breezhaler, and Ultibro(TM) Breezhaler, the leading LABA/LAMA treatment.

This next generation of the Breezhaler(TM) inhaler will enable patients to have access to their own data on the use of their inhaler in near real time. The small, disposable and low power module contained within the inhaler device can detect and report usage, the time that the inhaler is used, as well as additional relevant information for patients and physicians. The module then wirelessly sends the data to the patient's smartphone and a Novartis COPD mobile application, which sends the data to the cloud, allowing patients and potentially their healthcare providers to monitor their COPD. The connected device will be ready for use by patients, with no assembly required.

"Novartis supports patients being empowered to make it easier for them to manage their chronic conditions," said David Epstein, Head Novartis Pharmaceuticals. "By enabling near real time data capture from the patient and the connected Breezhaler(TM) device, patients can monitor their own adherence to the medication they take which is vital to their health outcomes."   

Novartis aims to be the first company in respiratory medicine to offer a completely integrated, connected delivery device to provide a seamless, easy to use and simple experience for patients.

About Ultibro Breezhaler
Ultibro Breezhaler 110/50 mcg is a once-daily LABA/LAMA dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD2. Clinical trials have shown that it offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including SFC 50/500 mcg and open-label tiotropium (18 mcg). Ultibro Breezhaler is currently approved for use in over 80 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. In the U.S. the treatment is approved as a indacaterol 27.5 mcg/glycopyrrolate 15.6 mcg administered twice daily, known as Utibron(TM) Neohaler®.   

About the Novartis COPD portfolio

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD 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. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly. 

About COPD 
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million people worldwide and is the third leading cause of death. It is progressive (usually gets worse over time), and can be a life-threatening disease. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients' function (i.e. activity limitation, decreased mobility) and quality of life. It is often considered to be a disease of later years but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation. 

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "focus," "plans," "will," "potentially," "aims," "committed," "continues," or similar terms, or by express or implied discussions regarding potential marketing authorizations for the next generation of the Breezhaler inhaler, potential new indications or labeling for Ultibro Breezhaler, Seebri Breezhaler, Onbrez Breezhaler and the other products in the Novartis COPD portfolio, or regarding potential future revenues from such devices and products. 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 the next generation of the Breezhaler inhaler will be approved for use in any market, or at any particular time. Neither can there be any guarantee that any of the products in the Novartis COPD portfolio 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 such devices and products will be commercially successful in the future. In particular, management's expectations regarding the next generation of the Breezhaler inhaler and the products in the Novartis COPD portfolio 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 safety issues; unexpected manufacturing or quality 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 and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 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 120,000 full-time equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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