Novartis International AG: New patient survey highlights need for more action to help severe asthma patients gain control of their disease

• Large-scale European patient survey found that 94% of severe allergic asthma patients were unable to fully control their disease
   
• These new data underscore the disconnect between self-perceived control and clinical reality; a potentially limiting factor in patients seeking support to better control their condition
   
• Helping patients recognize the possibilities of living a life with properly controlled asthma is central to a major new global patient engagement program being launched by Novartis, called Billion Breaths

Basel, 17^th June, 2017 - Novartis announced the results of a new survey of 904 severe asthma patients, presented today for the first time at the European Academy of Allergy and Clinical Immunology (EAACI) Congress[1]. Data from the 'Still Fighting for Breath' survey demonstrate that, despite the widespread availability of oral and inhaled treatments, asthma still places a huge burden on the personal and professional lives of those living with the disease in Europe.

The new survey revealed that high levels of uncontrolled disease still exist amongst adults and children with severe asthma. Asthma attacks (also known as exacerbations) were reported to be extremely common. Nearly three quarters (74%) of patients surveyed  experienced an attack serious enough to have required treatment from a healthcare professional in the emergency room, ambulance or at home.  Furthermore, almost a third (32%) of patients experienced three or more exacerbations during this time period. While a majority of patients (54%) experiencing an exacerbation physically recovered after treatment within 24 hours, these patients often remained psychologically affected for a prolonged period of time after the exacerbation, with almost a fifth of them (19%) reporting effects persisting over a week[1].

Importantly, this new research found a significant discrepancy between "perceived" versus "real life" asthma control. Specifically, nearly half (46%) of the patients surveyed had self-estimated themselves as being "controlled", which is a marked contrast to the 6% of patients that were actually deemed as "controlled" according to the Global Initiative for Asthma (GINA) clinical guidelines. This discrepancy may be a limiting factor in patients seeking support to control their condition.

"The results from this new survey are important as the data demonstrate that too many patients in Europe are living with the daily burden of uncontrolled severe asthma. As such, this patient population may be significantly under-served", said Professor Antonella Muraro, one of the authors of the survey. "More needs to be done and the first step is to bridge the gap between the perceptions of 'good' control vs reality, among people with asthma. We need to focus greater efforts on empowering and educating those living with asthma to fight for better outcomes and to help them achieve a life unrestricted by their condition." 

In addition to revealing the high levels of uncontrolled disease, the survey also underscored the disruptive impact that living with severe asthma has on the lives of patients. Nearly nine out of ten patients reported that their condition impacted their daily living (88%) and 84% reported that it impacted physical activities, with almost all patients (97%) reporting it disturbed their sleep. Significantly, half of the patients surveyed believe their professional lives are negatively impacted by their condition.

In response to the survey findings Novartis is launching a new patient engagement program, entitled Billion Breaths. The program will encourage people to set activity goals and provide advice and support to help them achieve a life less restricted by asthma [https://www.youtube.com/watch?v=kniyOgnpQr4].

About the asthma impact study in Europe
The study enrolled 904 adult patients (>=18 years) and children (6-17 years old) suffering from severe persistent asthma.  It spanned several countries, including the United Kingdom (n=190), Germany (n=170), France (n=170, Italy (n=116), Spain (n=115) and Portugal (n=30).

Data were collected through an online survey between July 12 and October 31 2016. Data for adolescent and pediatric patients were obtained through caregivers. Collection and analysis of all data was completed by GFK Health on behalf of Novartis.

The severe asthmatic patients in this survey were diagnosed by respiratory physicians (38%), general practitioners (33%), allergists (23%) and pediatricians (5%). On average, adults were diagnosed with the disease 15 years ago, adolescents seven years old and pediatrics three years ago. According to the patients' understanding 49% considered themselves to have non-allergic asthma (no additional tests were performed).

About asthma
Asthma is a global health problem[2] affecting an estimated 300 million people worldwide[3]. It is a common long-term condition that can cause coughing, wheezing, chest tightness and breathlessness.

There is no cure for asthma and treatment focuses on symptom relief[3]. Asthma symptoms can either gradually or suddenly become worse. This is commonly referred to as an "asthma attack" or "exacerbation". Severe exacerbations may require hospital treatment and can be life- threatening[4]. However, when appropriate treatment is instituted, asthma can be controlled without symptoms.

There are many different types of asthma. Severe asthma is a specific form of asthma that requires specialist care and support.  It affects approximately 5% of people with the condition. A patient with severe asthma may have breathing difficulties and is also at risk of serious exacerbations[5].

Approximately 87% of severe asthma patients have taken oral corticosteroids (OCS), for a reported average period of 20 days in the last six months[1]. The updated 2017 GINA guidelines for asthma management state that patients should be provided with written guidance on when/how to commence OCS treatment, typically a short course (40mg/day for 5-7 days), and should also be advised of the potential side effects that may occur when taking OCS[2].

Disclaimer
This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as "potentially," "launched," "may," "focus," "launching," "encourage," or similar expressions. Such forward-looking statements reflect the current views of the Group 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 expressed or implied by such statements. These expectations could be affected by, among other things, risks and factors referred to in the Risk Factors section of 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 it in the future.

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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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References
[1] Katsaounou P, Conde L G, Kroegel C et al. The challenges of living with severe asthma in Europe. Abstract #858 presented at EACCI Congress 2017
[2] Global Strategy for Asthma Management and Prevention (2017). http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/ [Accessed March 2017]
[3] World Health Organization. Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach, 2007. http://www.who.int/gard/publications/GARD%20Book%202007.pdf. [Accessed April 2017]
[4] NHS Choices - Asthma. http://www.nhs.uk/conditions/Asthma/Pages/Introduction.aspx. [Accessed April 2017]
[5] Asthma UK, Severe asthma and difficult to control asthma. https://www.asthma.org.uk/advice/understanding-asthma/types/severe-asthma/ [Accessed March 2017]

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