Investigational Biologic for the Treatment of Inadequately Controlled
Asthma in Patients with Elevated Blood Eosinophils Accepted for Review
JERUSALEM--(BUSINESS WIRE)--Jun. 15, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review the
Biologics License Application (BLA) for reslizumab, the company’s
investigational humanized monoclonal antibody (mAb) which targets
interleukin-5 (IL-5), for the treatment of inadequately controlled
asthma in adult and adolescent patients with elevated blood eosinophils,
despite an inhaled corticosteroid (ICS)-based regimen.
“Despite currently available medicines, uncontrolled asthma remains a
serious problem for patients, physicians and healthcare systems,
highlighting the need for targeted new treatment options,” said Dr.
Michael Hayden, President of Global R&D and Chief Scientific Officer at
Teva Pharmaceutical Industries Ltd. “The reslizumab BLA filing
acceptance represents a significant milestone for Teva as we work toward
serving a specific asthma patient population that is defined by elevated
blood eosinophil levels and inadequately controlled symptoms despite
standard of care therapy. In clinical trials, patients treated with
reslizumab showed significant reductions in the rate of asthma
exacerbations and significant improvement in lung function. If approved,
we believe reslizumab will serve as an important new targeted treatment
option to achieve better asthma control for patients with
eosinophil-mediated disease.”
The BLA for reslizumab includes data from Teva’s Phase III BREATH
clinical trial program. The program consisted of four separate
placebo-controlled Phase III trials involving more than 1,700 adult and
adolescent asthma patients with elevated blood eosinophils, whose
symptoms were inadequately controlled with inhaled corticosteroid-based
therapies. Results from these studies demonstrated that reslizumab, in
comparison to placebo, reduced asthma exacerbation rates by at least
half and provided significant improvement in lung function and other
secondary measures of asthma control when added to an existing ICS-based
therapy. 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.
Results from the reslizumab BREATH program were recently presented at
the American Thoracic Society 2015 Annual Meeting and the American
Academy of Allergy, Asthma and Immunology 2015 Annual Meeting, in
addition to being published in The Lancet Respiratory Medicine. The
BLA for reslizumab has been accepted for filing by the FDA for standard
review, with FDA Regulatory Action expected in March 2016.
About Reslizumab
Reslizumab is an investigational humanized monoclonal antibody which
targets interleukin-5 (IL-5). IL-5 is a key cytokine involved in the
maturation, recruitment, and activation of eosinophils, which are
inflammatory white blood cells implicated in a number of diseases, such
as asthma. Elevated levels of blood eosinophils are a risk factor for
future asthma exacerbations. Reslizumab binds circulating IL-5 thereby
preventing IL-5 from binding to its receptor.
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 Eosinophils
Eosinophils 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. IL-5
has been shown to play a crucial role in maturation, growth and
activation of eosinophils. Increased levels of eosinophils in the sputum
and blood have been shown to correlate with severity and frequency of
asthma exacerbations.
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.
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
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements 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 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,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix,
(215) 591-8912
United States
or
Ran Meir, (215)
591-3033
United States
or
Tomer Amitai, 972 (3)
926-7656
Israel
or
PR:
Iris Beck Codner, 972
(3) 926-7687
Israel
or
Denise Bradley, (215)
591-8974
United States
or
Nancy Leone, (215)
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United States