NICE Recommends CINQAERO® (reslizumab) for the Treatment of Severe Eosinophilic Asthma
July 20 2017 - 5:00AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced that the National Institute for Health and Care
Excellence (NICE) in England has recommended CINQAERO® (reslizumab)
in its Final Appraisal Determination (FAD). CINQAERO® is a
humanized interleukin-5 (IL-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.
“Despite the availability of current treatment options, many
patients with severe eosinophilic asthma still experience
uncontrolled symptoms and serious asthma attacks,” said Ian Pavord,
Professor of Respiratory Medicine at the University of Oxford. “The
NICE decision will be welcomed by the clinical community as it
provides access to a new treatment option for these patients.”
“Reslizumab has the potential to dramatically improve the
quality of life for some people living with severe asthma, and we
are delighted that it has been recommended for use on the NHS,”
said Kay Boycott, Chief Executive of Asthma UK. “New monoclonal
antibody treatments, which have shown success in clinical trials
are likely to be effective in treating around 30-40% of those
living with severe asthma, so it is imperative that they are made
available. While today’s news is an encouraging step forward, it’s
important to note that these treatments will only benefit a certain
group of people. There remain many thousands more for whom no
effective treatments are available. More research is needed so that
in the future all people with severe asthma will have an effective
treatment option.”
This decision is based on a dossier submitted to NICE for a
Single Technology Appraisal (STA).
Following issuance of the FAD, NICE will provide its formal
guidance to the NHS in England. The full NICE recommendations can
be viewed on their website.
“Teva is very pleased to receive this decision by NICE as we
seek to expand the availability of reslizumab (CINQAERO®) globally
in an effort to ensure that patients living with severe,
uncontrolled asthma have access to this treatment option,” said
Sven Dethlefs, SVP and Head of Global Respiratory Medicines at
Teva. “The future of respiratory care shows great promise, and we
are proud to be at the forefront of providing innovative
medications for such a patient population whose quality of life is
often severely impacted by asthma.”
The European Commission granted marketing authorization for
CINQAERO® in August 2016 as an add-on therapy in adult patients
with severe eosinophilic asthma inadequately controlled, despite
high-dose inhaled corticosteroids plus another medicinal product
for maintenance treatment. Most recently, the German Federal Joint
Committee (G-BA) confirmed that CINQAERO® provided additional
benefit in July 2017, with price negotiations with the National
Association of Statutory Health Insurance Physicians beginning four
weeks after the G-BA decision.
About CINQAERO® (reslizumab)CINQAERO® is a
humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4
kappa). IL-5 is the most selective eosinophil-active cytokine 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. CINQAERO® binds to human IL-5
and prevents it from binding to the IL-5 receptor, thereby reducing
eosinophilic inflammation.
About Teva RespiratoryTeva Respiratory develops and
delivers high-quality treatment options for respiratory conditions,
including asthma, COPD, cystic fibrosis and allergic rhinitis. The
Teva Respiratory portfolio is centred 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-activated 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 TevaTeva Pharmaceutical Industries Ltd. (NYSE and
TASE: TEVA) is a leading global pharmaceutical company that
delivers high-quality, patient-centric healthcare solutions used by
approximately 200 million patients in 100 markets every day.
Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well
as late-stage development programs for other disorders of the
central nervous system, including movement disorders, migraine,
pain and neurodegenerative conditions, as well as a broad portfolio
of respiratory products. Teva is leveraging its generics and
specialty capabilities in order to seek new ways of addressing
unmet patient needs by combining drug development with devices,
services and technologies. Teva's net revenues in 2016 were $21.9
billion. For more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding CINQAERO®, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- the uncertainty of commercial success
of CINQAERO®;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; the uncertainty of clinical
success and obtaining regulatory approvals and our ability to
achieve expected results from investments in our product pipeline;
competition from companies with greater resources and capabilities;
and the effectiveness of our patents and other measures to protect
our intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with complex
Medicare and Medicaid reporting and payment obligations; and
environmental risks;and other factors discussed in our Annual
Report on Form 20-F for the year ended December 31, 2016 (“Annual
Report”), including in the section captioned “Risk Factors,” and in
our other filings with the U.S. Securities and Exchange Commission,
which are available at www.sec.gov and www.tevapharm.com.
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 contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20170720005432/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7687orUnited
StatesDenise Bradley, 215-591-8974
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