Teva Receives CHMP Positive Opinion for CINQAERO® (reslizumab)
24 Juin 2016 - 1:11PM
Business Wire
Add-On Therapy Targeting IL-5 in Adults with
Severe Eosinophilic Asthma Pending Marketing Authorization in
Europe
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 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:United StatesKevin C.
Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, 215-284-0213
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