New Biologic for Add-On Maintenance Treatment
in Adults with Severe Asthma and an Eosinophilic Phenotype
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the U.S. Food and Drug Administration (FDA) has
approved CINQAIR® (reslizumab) Injection, an interleukin 5
antagonist monoclonal antibody (IgG4 kappa) indicated for add-on
maintenance treatment of patients with severe asthma aged 18 years
and older, and with an eosinophilic phenotype.
CINQAIR® is administered by intravenous (IV) infusion at a
weight-based dose of 3 mg/kg once every four weeks. The treatment
is expected to become commercially available to patients, by
prescription, during the second quarter of 2016.
“Despite ongoing treatment with today’s standard of care, many
patients with severe asthma remain inadequately controlled, the
implications of which can lead to increased exacerbations and
hospitalization,” said Professor Mario Castro, Washington
University School of Medicine, Division of Pulmonary and Critical
Care Medicine and lead investigator. “The approval of CINQAIR®
marks an important advancement in the treatment paradigm for asthma
as the therapy has demonstrated significant improvement in multiple
measures of asthma control. As a practicing physician, I look
forward to the opportunity to provide my patients, who have severe
uncontrolled asthma and fit the profile for CINQAIR®, with an
option that has the potential to help them achieve control of their
disease.”
“Teva’s specialty medicines pipeline is centered on developing
therapies to address the unmet needs of patients, healthcare
providers, caregivers, and payers in our key therapeutic areas of
focus,” said Michael Hayden, M.D., Ph.D., President of Global
R&D and Chief Scientific Officer at Teva. “We are proud to
demonstrate our commitment to advancing the treatment of
respiratory disease with the development of CINQAIR®, a targeted
therapy for a specific subset of patients with severe asthma, a
disease which can present significant treatment challenges that are
not adequately addressed by currently available medicines.”
The FDA approval of CINQAIR® was based on review of 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 safety profile in a population
of 1,028 adult and adolescent asthma patients treated with CINQAIR®
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. They demonstrated that treatment with
CINQAIR® was associated with reduction in asthma exacerbations of
up to 59% as well as significant improvement in lung function,
symptoms, and asthma-related quality of life. The most common
adverse reaction (incidence greater than or equal to two percent)
in patients treated with CINQAIR® was oropharyngeal pain.
Anaphylaxis was reported at a rate of 0.3% in the
placebo-controlled studies (n=1028). An imbalance in malignancy was
observed in the Phase III trials (CINQAIR® 0.6% and placebo 0.3%).
The observed malignancies were diverse in nature and were diagnosed
within less than six months of exposure to CINQAIR®.
“Teva is committed to delivering innovations in asthma care to
help patients, across the spectrum of this heterogeneous disease,
achieve improved symptom control and quality of life,” said Rob
Koremans, M.D., President and CEO of Teva Global Specialty
Medicines. “We are pleased to expand our growing respiratory
portfolio with CINQAIR® in the U.S. With this therapy, we now have
the ability to provide a targeted, new treatment option for an
underserved patient group, thus helping to address a major unmet
need in asthma management.”
Upon commercial availability of CINQAIR®, Teva will launch Teva
Support Solutions℠, a comprehensive program that will provide
personalized support, training and education to healthcare
providers and patients who have been prescribed CINQAIR®.
This is the first approval of CINQAIR® (reslizumab) anywhere in
the world. Reslizumab has been submitted to and is currently under
review by European Medicines Agency (EMA) and Health Canada.
Indications and Usage
CINQAIR® (reslizumab) is an interleukin 5 antagonist monoclonal
antibody (IgG4 Kappa) indicated for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, with an
eosinophilic phenotype.
Limitations of Use: CINQAIR® is not
indicated for treatment of other eosinophilic conditions or relief
of acute bronchospasm or status asthmaticus.
Important Safety Information
WARNING: ANAPHYLAXIS
Anaphylaxis has been observed with CINQAIR infusion in 0.3%
of patients in placebo-controlled clinical studies. Anaphylaxis was
reported as early as the second dose of CINQAIR.
Anaphylaxis can be life-threatening. Patients should be
observed for an appropriate period of time after CINQAIR
administration by a healthcare professional prepared to manage
anaphylaxis. Discontinue CINQAIR immediately if the patient
experiences signs or symptoms of anaphylaxis.
CINQAIR is contraindicated in patients who have known
hypersensitivity to reslizumab or any of its excipients.
In placebo-controlled clinical studies, 6/1028 (0.6%) patients
receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm
reported compared to 2/730 (0.3%) patients in the placebo
group.
No clinical studies have been conducted to assess reduction of
maintenance corticosteroid dosages following administration of
CINQAIR. Do not discontinue systemic or inhaled corticosteroids
abruptly upon initiation of therapy with CINQAIR. Reductions in
corticosteroid dose, if appropriate, should be gradual and
performed under the supervision of a physician. Reduction in
corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Eosinophils may be involved in the immunological response to
some parasitic (helminth) infections. Treat patients with
pre-existing helminth infections before initiating CINQAIR. If
patients become infected while receiving treatment with CINQAIR and
do not respond to anti-helminth treatment, discontinue treatment
with CINQAIR until infection resolves.
Adverse reactions that occurred at greater than or equal to 2%
incidence and more commonly than in the placebo group included 1
event: oropharyngeal pain (2.6% vs. 2.2%).
Please click here for full Prescribing Information, including
Boxed Warning:
http://www.cinqair.com/pdf/PrescribingInformation.pdf. Prior to the
availability of full Prescribing Information online, a copy may be
requested from the US Medical Information Contact Center for Teva
Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and
USMedInfo@tevapharm.com or Teva’s Public Relations or Investor
Relations contacts.
About CINQAIR® (reslizumab) Injection
CINQAIR® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa), approved by the U.S. Food and
Drug Administration (FDA) for add-on maintenance treatment of
patients with severe asthma in aged 18 years and older, and with an
eosinophilic phenotype. IL-5 is the most selective eosinophil
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.
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 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® (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 realizing such benefits); the fact that following the
consummation of the Actavis Generics acquisition, we will be
dependent to a much larger extent than previously on our generic
pharmaceutical business; potential restrictions on our ability to
engage in additional transactions or incur additional indebtedness
as a result of the substantial amount of debt we will incur to
finance the Actavis Generics acquisition; the fact that for a
period of time following the consummation of the Actavis Generics
acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; 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 investments in our pipeline of specialty and other
products; 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; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; 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
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, 2015 and
in our other filings with the U.S. Securities and Exchange
Commission (the "SEC"). 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 statements or other
information, whether as a result of new information, future events
or otherwise.
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Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7687Denise Bradley, United States, 215-591-8974Nancy
Leone, United States, 215-284-0213
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