Teva Presents New Reslizumab Data at European Respiratory Society (ERS) International Congress 2015

New Analysis Shows Reslizumab Reduced Asthma Exacerbations by 75
percent in Patients with Late Onset Asthma and Elevated Blood Eosinophils

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today presented results
from a post hoc analysis of two pivotal Phase III clinical trials
showing that treatment with reslizumab reduced clinical asthma
exacerbations (CAEs) by 75 percent versus placebo in a subgroup of
patients with late onset asthma (diagnosed at 40 years of age and older)
with elevated blood eosinophils, who were inadequately controlled on
inhaled corticosteroids (ICS). Reslizumab is a humanized
anti-interleukin-5 (IL-5) monoclonal antibody (mAb) for which Teva is
seeking approval in the treatment of asthma in patients with elevated
blood eosinophils who are inadequately controlled on an ICS-based
regimen. These results were presented as a late-breaking abstract at the
2015 ERS International Congress in Amsterdam.

“Asthma diagnosed after the age of 40 falls into a distinct subtype
which is often very challenging to treat,” commented abstract author,
Professor Guy Brusselle, Ghent University Hospital, Belgium. “These
latest results for reslizumab are therefore particularly encouraging, as
they indicate that the drug, in combination with standard of care
therapy, may provide these patients with a much-needed new option to
help alleviate their symptoms and significantly improve their asthma

In order to determine the influence that age of asthma onset has as it
relates to the efficacy of reslizumab, results were pooled from two
Phase III clinical trials that investigated reslizumab IV 3 mg/kg in
patients who were inadequately controlled on an ICS-based regimen, who
had at least one asthma exacerbation within the previous 12 months, and
a blood eosinophil count of ≥400/µL. These post-hoc analysis results
indicate that, in the subgroup with late onset asthma, reslizumab showed
a 75 percent reduction in asthma exacerbations and improvement in lung
function as measured by forced expiratory volume in one second (FEV1).
In the overall pooled patient population, asthma exacerbations were
reduced by 54 percent; in the subgroup of subjects diagnosed with asthma
at <40 years of age, exacerbations were reduced by 42 percent.

Data for this post-hoc analysis were pooled from two identical Phase III
clinical trials (which were part of the BREATH clinical program) that
comprised four placebo-controlled studies whose population of 1,700
adult and adolescent asthma patients (aged 12-75 years) had elevated
blood eosinophils and symptoms that were inadequately controlled with
ICS-based therapies. Common adverse events (occurring in >5 percent of
patients overall) in the reslizumab treatment group were comparable to
placebo and included asthma, nasopharyngitis, upper respiratory
infections, sinusitis, influenza and headache. Two patients treated with
reslizumab experienced anaphylactic reactions. In both cases, patients
responded to standard treatment administered at the study centre.
Patients were then withdrawn from participation in the study.

“Asthma is a complex disease, and some phenotypes, such as late onset
asthma with elevated blood eosinophils, can present particularly
significant treatment challenges that are not adequately addressed by
currently available therapies,” said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva. “Through
the development of novel, targeted therapies, like reslizumab, Teva aims
to provide safe and effective new treatment options to help more
patients achieve improved asthma control.”

About Reslizumab

Reslizumab is an investigational humanized monoclonal antibody developed
to target interleukin-5 (IL-5). IL-5 is a key cytokine shown to play a
crucial role in the maturation, activation and survival of eosinophils,
which are a type of white blood cell that are present at elevated levels
in the lungs and blood of many asthmatics. Evidence shows that
eosinophils play an active role in the pathogenesis of the disease.
Increased levels of eosinophils in the sputum and blood have been shown
to positively correlate with disease severity and increased risk of
asthma exacerbations. Reslizumab is thought to act by binding
circulating IL-5 and preventing IL-5 from interacting with its receptor.

About Asthma

Asthma is a chronic (long term) disease usually characterized by airway
inflammation and narrowing of the airways, the severity and prognosis of
which can vary over time. Asthma may cause recurring periods of wheezing
(a whistling sound when you breathe), chest tightness, shortness of
breath and coughing that often occurs at night or early in the morning.
Without appropriate treatment, asthma symptoms may become more severe
and result in an asthma attack, which can lead to hospitalization and,
in extreme cases, even death.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva’s net revenues in 2014 amounted to $20.3
billion. For more information, visit

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Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix
215- 591-8912
Ran Meir
United States

972 (3) 926-7656
Beck Codner

972 (3) 926-7687

United States

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