JERUSALEM--(BUSINESS WIRE)--Dec. 10, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that
the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs
Advisory Committee recommended approval of reslizumab, a humanized
anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in
adult patients aged 18 years and older. Reslizumab is a targeted
biologic therapy for the treatment of inadequately controlled asthma in
patients with elevated blood eosinophils, despite an inhaled
corticosteroid (ICS)-based treatment regimen.
“Patient stratification based on eosinophil levels has been an important
advancement in the treatment of asthma,” said Michael Hayden, M.D.,
Ph.D., President of Global R&D and Chief Scientific Officer at Teva
Pharmaceutical Industries Ltd. “We are very encouraged by the outcome of
today’s FDA Advisory Committee meeting, which brings us one step closer
to potentially providing a new, targeted treatment option for a specific
group of patients with inadequately controlled asthma and evidence of
ongoing eosinophilic inflammation. This group of patients often
experiences persistent symptoms despite standard-of-care treatment,
demonstrating a need for more targeted treatment options based on
patient phenotype.”
The Advisory Committee's recommendation will be considered by the FDA in
its review of the Biologics License Application (BLA) for reslizumab.
The FDA is not bound by the Committee's recommendation, but takes its
advice into consideration when reviewing investigational medicines. The
reslizumab BLA was accepted for standard review by the FDA and
Regulatory Action is expected in March 2016. Additional regulatory
filings for reslizumab have been completed in the EU and Canada.
About Reslizumab
Reslizumab is an investigational humanized interleukin-5 (IL-5)
antagonist IgG4K monoclonal antibody (mAb), for the treatment
of inadequately controlled asthma in adult and adolescent patients with
elevated blood eosinophils, despite an inhaled corticosteroid
(ICS)-based regimen. IL-5 is the most selective eosinophil cytokine
known and plays a major role in the maturation, activation and survival
of eosinophils, which are the predominant type of white blood cell
underlying chronic airway inflammation in the eosinophilic phenotype of
asthma. In asthma patients, elevated blood eosinophils ≥400 cells/mcL
are associated with compromised lung function, persistent symptoms, and
increased risk of exacerbations. Reslizumab is thought to act by binding
to and neutralizing human IL-5 to reduce eosinophilic inflammation.
Reslizumab has been submitted for and is currently under review by the
U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA)
and Health Canada.
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 inadequately controlled 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 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 specialty products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from generic equivalents such as the recently launched Sandoz product)
and our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; 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;
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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
Nancy Leone, 215-284-0213