Teva Presents First Real-World Evidence Demonstrating Treatment with DuoResp Spiromax® Inhaler was Comparable to Symbicort Turbuhaler®

AMSTERDAM, September 12, 2017 /PRNewswire/ --

ONLY FOR PAN-EUROPEAN/ EUROPEAN ENGLISH LANGUAGE MEDICAL TRADE MEDIA  

Study Highlights Improved Outcomes for Asthma Patients Including Fewer Exacerbations Following Change in Treatment to DuoResp Spiromax^®

Teva Pharmaceuticals Europe B.V., (NYSE and TASE: TEVA) today announced data from a real-world evidence study showing that in patients with asthma and chronic obstructive pulmonary disease (COPD), DuoResp Spiromax^®(budesonide/formoterol fumarate dihydrate) was non-inferior to Symbicort Turbuhaler^® (budesonide/formoterol fumarate dihydrate) in regards to disease control. DuoResp Spiromax^® aims to reduce common inhaler errors and enhance usability for patients with asthma and COPD, delivering medication via a breath-activated, multi-dose dry powder inhaler (MDPI). In asthma patients using DuoResp Spiromax^® data showed improvements in health outcomes, including fewer exacerbations, reduction in use of rescue inhalers, and improved treatment stability.^[1] The study was presented at the 2017 European Respiratory Society (ERS) International Congress in Milan, Italy, the largest respiratory conference in the world.

Asthma affects approximately 30 million people across Europe^[2], with 5.4 million of those people living in the UK alone.^[3] Characterised by the chronic inflammation and narrowing of the airways, it can cause recurrent episodes of wheezing, chest tightness, cough and shortness of breath.^[2] In some cases, symptoms may worsen, leading to more severe airflow obstruction and an asthma attack.^[2] A recent study published in the Annals of the American Thoracic Society found that approximately 76 percent of asthma patients still struggle to use their metered dose inhaler correctly leading to an increased risk for asthma attacks.^[4]

"Despite currently available therapies, patients continue to exhibit poor inhaler technique, leading to reduced control. As such, it's encouraging to have products on the market that were designed with the patient in mind," said Dr. Nicolas Roche, lead investigator and Professor of Respiratory Medicine at University Paris Descartes in Paris, France. "To see non-inferior results with DuoResp Spiromax^® in a routine clinical setting allows us - as physicians - to be confident that this delivery system can be effective amongst the diversity of our 'real' respiratory patients."

The real-world study^[1] evaluated the non-inferiority in regards to disease control of DuoResp Spiromax^® following change in treatment from Symbicort Turbuhaler^® versus staying on Symbicort Turbuhaler^® in 1,091 patients with respiratory disease, including 743 with asthma.

"The real-world data support the use of DuoResp Spiromax^® in treating asthma and COPD - two chronic respiratory diseases that pose a significant challenge to manage, and where patients struggle to gain control of their condition," said Sophie Leyman, Senior Director, Respiratory Medical Affairs, Teva Pharmaceuticals Europe. "These results reinforce the value of incorporating medications, such as DuoResp^® and Aerivio^®, into the Spiromax^® inhaler as we seek to provide patients with access to innovative device technologies that can improve inhaler technique. The ultimate aspiration is to reduce the number of asthma attacks and the need for rescue medication, allowing patients to more effectively manage their disease."

DuoResp Spiromax^® received marketing authorisation from the European Commission on 29th April 2014, and is currently available to patients in multiple countries across Europe, including amongst others, Bulgaria, Czech Republic, Croatia, Denmark, France, Germany, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden and the UK. Outside of Europe, DuoResp Spiromax^® received marketing authorisation in Russia, South Korea, Israel and Australia, and is currently available to patients in Russia, South Korea and Israel.

About DuoResp Spiromax^® (budesonide/formoterol fumarate dihydrate)   

DuoResp Spiromax^® contains a combination of budesonide, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a long-acting beta2-adrenergic agonist for the relief of bronchoconstriction in asthma and COPD. The Spiromax^® inhaler incorporates a specific combination of features, such as dose confirmation and dose counter, and provides consistent drug delivery across inspiratory flow rates.

About the Study 
The real-world study evaluated the non-inferiority in regards to disease control of DuoResp Spiromax^® following change in treatment from Symbicort Turbuhaler^® versus staying on Symbicort Turbuhaler^® in patients with respiratory disease. Of the 1,091 patients (743 with asthma, 348 with COPD) staying on Symbicort Turbuhaler^®, 385 matched patients (253 with asthma, 132 with COPD) who changed to DuoResp Spiromax^® had non-inferiority in Risk Domain Control. In asthma patients, DuoResp Spiromax^® - when compared to Symbicort Turbuhaler^® - resulted in fewer asthma attacks (adjusted rate ratio [RR] 0.76; p=0.044), lower odds of being in a high short-acting beta agonist dose category (OR 0.71; p=0.034), used fewer SABA inhalers (RR 0.92; p=0.019) and higher odds of achieving treatment stability (adjusted odds ratio 1.44; p=0.037). No significant differences were found in COPD patients.^[1] The full abstract can be found online here.

About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD, cystic fibrosis and allergic rhinitis. The Teva Respiratory portfolio is centred on optimising respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company's respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-activated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.

About Teva
Teva is among the top 15 global pharmaceutical companies globally, delivering high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 60 markets every day. Teva produces a leading innovative treatment for multiple sclerosis and has late-stage development programs for a range of disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions. With its European headquarters in Amsterdam, the Netherlands, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a broad range of products in nearly every therapeutic area. Teva draws on its specialty and generics capabilities to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.

* Symbicort Turbuhaler^® is a registered trademark of the AstraZeneca group of companies.

References   

1. Roche N et al. Real-life evaluation of budesonide/formoterol (DuoResp Spiromax®) for the management of asthma and COPD in the UK. Presented at the European Respiratory Society (ERS) 2017; Milan, Italy, Poster #PA937. 

2. European Respiratory Society. European Lung White Book; Chapter 12 - Adult Asthma. Available at: http://www.erswhitebook.org/chapters/adult-asthma/. Last accessed August 2017. 

3. Asthma UK, Asthma Facts & Statistics, Available at: https://www.asthma.org.uk/about/media/facts-and-statistics/. Accessed on August 28, 2017. 

4. American Thoracic Society, Rescue Inhaler Study: New Approach Increases Mastery of Life Saving Technique, March 18, 2016. Available at: http://www.thoracic.org/about/newsroom/press-releases/journal/rescue-inhaler-study-new-approach-increases-mastery-of-life-saving-technique.php. Last accessed August 2017.