Further Analysis of Pivotal Phase III Studies
Show Reduction in Asthma Exacerbation Rates by at least half (50%
and 59% respectively) and Significant Improvement in Lung Function
in Patients Treated with Reslizumab
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced
today that The Lancet Respiratory Medicine has published data from
two replicate 52-week Phase III global studies on the company’s
investigational anti-interleukin-5 (IL-5) monoclonal antibody,
reslizumab. The data showed that treatment with reslizumab,
compared to placebo, significantly reduced the annual rate of
clinical asthma exacerbations (Study 1, 50% and Study 2, 59%),
significantly improved lung function, and provided sustained
improvement in multiple secondary measures of asthma control in
patients with asthma and elevated blood eosinophils who were
inadequately controlled on an inhaled corticosteroid (ICS)-based
regimen. Findings from the studies were also presented today at the
2015 American Academy of Allergy, Asthma & Immunology (AAAAI)
Annual Meeting in a late-breaking oral session.
“Results from these Phase III studies highlight the importance
of phenotype-targeted therapies and represent a potential change in
the treatment paradigm for patients with moderate-to-severe asthma
and elevated blood eosinophil levels who are uncontrolled on an
ICS-based therapy,” said Professor Mario Castro, Washington
University School of Medicine, Division of Pulmonary and Critical
Care Medicine and lead investigator. “If approved, reslizumab could
provide doctors with a new treatment option that has the potential
to both significantly reduce patients’ asthma exacerbations and
improve their current symptom control and lung function.”
Across both trials, a total of 953 patients with asthma and
elevated blood eosinophil counts, who were uncontrolled despite
receiving medium-to-high doses of ICS with or without an additional
controller, and who had at least one asthma exacerbation in the
prior year, were randomized to receive intravenously administered
reslizumab (3.0 mg/kg) or placebo every four weeks for one year.
Approximately 80% of patients in these trials were also taking an
inhaled long-acting beta-agonist. The primary efficacy variable was
the annual frequency of clinical asthma exacerbations. Lung
function, quality of life, asthma control, and safety were also
assessed.
Primary efficacy was met in both studies. Results were
consistent and demonstrated that reslizumab reduced the annual
frequency of clinical exacerbations by at least half (50% and 59%
respectively), compared to placebo. Lung function also improved by
week four and was maintained through one year in both studies.
Furthermore, significant improvements were observed in the Asthma
Quality of Life, Asthma Control Questionnaire and Asthma Symptom
Utility Index scores. Common adverse events in the reslizumab
treatment group were comparable to placebo and included worsening
of asthma, nasopharyngitis, upper respiratory infections,
sinusitis, influenza and headache. Two anaphylactic reactions were
reported and resolved following medical treatment at the study
site.
“We are immensely impressed by the continued positive results
seen across the entire Phase III clinical trial program for
reslizumab,” said Dr. Michael Hayden, President of Global R&D
and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd.
“There is a tremendous need within the asthma patient population
for targeted treatment options that may limit the number of annual
exacerbations and aid patients in effectively controlling their
condition. If approved, we look forward to bringing this important
new therapy to market as soon as possible.”
The data published today in The Lancet Respiratory Medicine and
presented at AAAAI are part of the comprehensive Phase III clinical
trial program for reslizumab and further build upon Phase III trial
data previously presented at the European Respiratory Society (ERS)
International Congress in 2014. Regulatory submissions for
reslizumab are planned for the first half of 2015.
About Reslizumab
Reslizumab is an investigational humanized monoclonal antibody
(mAb) against interleukin-5 (IL-5). IL-5 has been shown to play a
crucial role in the maturation, and survival of eosinophils,
inflammatory white blood cells implicated in a number of allergic
diseases, such as asthma. Elevated levels of blood eosinophils are
a risk factor for future asthma exacerbations. Recent data from the
Phase III clinical program demonstrated that reslizumab
significantly reduced the annual rate of asthma exacerbations and
improved lung function and asthma symptoms in patients with
moderate to severe asthma with elevated blood eosinophils whose
symptoms were inadequately controlled by medium to high doses of
inhaled corticosteroids with or without an additional controller,
compared with placebo.
About the Studies
In two duplicate, double-blind, Phase III studies, a total of
953 patients with similar baseline characteristics, and with
moderate to severe asthma and elevated blood eosinophil levels were
randomized to receive either intravenous reslizumab (3.0 mg/kg)
(n=477) or placebo (n=476) every four weeks for one year. The
primary endpoint was the annual frequency of clinical asthma
exacerbations. Additional assessments included lung function,
quality of life, asthma control and safety.
Results from these studies demonstrated that patients receiving
reslizumab achieved reductions in clinical asthma exacerbations
(study 1 RR 0.50 [95%CI 0.37, 0.67], study 2 RR 0.41 [95%CI 0.28,
0.59], both P<0.0001) versus placebo. Lung function improved by
the first assessment at week four, and was maintained for one year
in both studies (change in FEV1 over 52 weeks was 0.126 L,
P<0.0001 and 0.090 L, P=0.006). Significant improvements from
baseline over 52 weeks were observed in Asthma Quality of Life
Questionnaire scores (0.302, P=0.0004 and 0.234, P=0.0052), Asthma
Control Questionnaire (-0.255, P=0.0002 and -0.242, P=0.0003) and
Asthma Symptom Utility Index (+0.061 [P<0.0001]; +0.036
[P=0.0011]). Common adverse events in the reslizumab treatment
group were similar to placebo; two anaphylactic reactions in the
reslizumab arm were reported that resolved with treatment at the
study site. Overall, reslizumab significantly reduced the annual
rate of clinical exacerbations and resulted in sustained
improvement in secondary measures of asthma control compared with
placebo.
About Asthma
Asthma is a chronic (long-term) disease usually characterized by
airway inflammation and narrowing of the airways, 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 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 www.tevapharm.com.
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Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
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expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our new 40 mg/mL version; the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions
as well as credit risks; the effectiveness of our patents,
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intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
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significant disruptions of our information technology systems or
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Annual Report on Form 20-F for the year ended December 31, 2014 and
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Commission. Forward-looking statements speak only as of the date on
which they are made and we assume no obligation to update or revise
any forward-looking statement, whether as a result of new
information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
MannixUnited States215-591-8912orRan MeirUnited
States215-591-3033orTomer AmitaiIsrael972 (3)
926-7656orPR:Iris Beck CodnerIsrael972 (3)
926-7687orDenise BradleyUnited States215-591-8974orNancy
LeoneUnited States215-284-0213
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