Add-On Therapy Targeting IL-5 in Adults with Severe Eosinophilic
Asthma Pending Marketing Authorization in Europe
JERUSALEM--(BUSINESS WIRE)--Jun. 24, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced
that the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion recommending
marketing authorization for CINQAERO® (reslizumab), a
humanized interleukin 5 antagonist monoclonal antibody for add-on
therapy in adult patients with severe eosinophilic asthma inadequately
controlled despite high-dose inhaled corticosteroids plus another
medicinal product for maintenance treatment.
“As a company committed to providing medicines and solutions for people
around the world living with respiratory disease, Teva is very pleased
to report a positive opinion by CHMP for the first intravenous anti-IL-5
biologic therapy for severe eosinophilic asthma,” said Rob Koremans, MD,
President and CEO of Teva Global Specialty Medicines. “In clinical
trials, reslizumab was effective in reducing asthma exacerbations,
improving lung function and improving asthma-related quality of life
measures. It is our hope that we can expand the availability of
reslizumab globally and soon bring this important treatment option to a
specific group of severe eosinophilic asthma patients in Europe who
struggle to control their symptoms despite today’s standard of care.”
The CHMP opinion is based on review of a Marketing Authorization
Application (MAA) containing efficacy and safety data from Teva’s global
development program in asthma. The clinical trial program consisted of
five placebo-controlled studies which demonstrated the efficacy and/or
safety profile in a population of 1,028 adult and adolescent asthma
patients treated with reslizumab 3 mg/kg that were inadequately
controlled with inhaled corticosteroid (ICS)-based therapies. Three of
these studies constituted the Phase III program in patients with asthma
and elevated blood eosinophils greater than 400 cells/mcL, where
reslizumab was administered for up to 52 weeks. They demonstrated that
treatment with reslizumab reduced the annual rate of asthma
exacerbations in the two 52-week trials by 50 and 59 percent,
respectively. In addition, reslizumab was associated with significant
improvement in lung function, patient-reported asthma control and
asthma-related quality of life measures. The most commonly reported
adverse reaction during treatment was increased blood creatinine
phosphokinase, which occurred in approximately two percent of patients.
These were mostly mild, transient, asymptomatic and did not lead to
treatment discontinuation. Adverse reactions of myalgia and anaphylactic
reaction were uncommon and occurred in less than one percent of patients.
The CHMP positive opinion is a formal recommendation to grant marketing
authorization for reslizumab. The recommendation will now be reviewed by
the European Commission, which has authority to approve medicines for
use in the 28 countries of the European Union along with Norway,
Liechtenstein and Iceland. The final decision by the European Commission
is expected in the second half of 2016.
About CINQAERO® (reslizumab)
CINQAERO® (reslizumab) is a humanized interleukin-5
(IL-5) antagonist monoclonal antibody (IgG4 kappa). IL-5 is the most
selective eosinophil-active cytokine known and plays a major role in the
maturation, activation and survival of eosinophils. In asthma patients,
the eosinophilic phenotype is associated with compromised lung function,
more frequent symptoms, and increased risk of exacerbations. Reslizumab
binds to human IL-5 and prevents it from binding to the IL-5 receptor,
thereby reducing eosinophilic inflammation. Reslizumab is currently
approved and marketed in the United States as CINQAIR®
(reslizumab) Injection for intravenous use with pending regulatory
approvals in other markets.
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options
for respiratory conditions, including asthma, COPD and allergic
rhinitis. The Teva Respiratory portfolio is centered on optimizing
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-actuated 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 Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by 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 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private 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
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contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the timing of
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the Actavis Generics acquisition, we will be dependent to a much larger
extent than previously on our generic pharmaceutical business; potential
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incur additional indebtedness as a result of the substantial amount of
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efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 and in our other filings with the U.S. Securities and Exchange
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result of new information, future events or otherwise.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
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Kevin
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Ran Meir, 215-591-3033
or
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Amitai, 972 (3) 926-7656
or
PR:
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Iris
Beck Codner, 972 (3) 926-7687
or
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