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 Respiratory
Teva 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.
Teva 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:
Teva Pharmaceutical Industries Ltd.
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