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

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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
(http://k4.ersnet.org/prod/v2/front/program/?e=42).

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/res
cue-inhaler-study-new-approach-increases-mastery-of-life-saving-techn
ique.php. Last accessed August 2017.

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