OXFORD, England, November 29, 2017 /PRNewswire/ --
Circassia Limited ("Circassia" or "the Company"), a specialty pharmaceutical company focused on respiratory disease, welcomes the publication of new clinical guidelines by the UK's National Institute for Health and Care Excellence (NICE)*, which recommend the use of fractional exhaled nitric oxide (FeNO) testing as part of asthma diagnosis.
The World Health Organisation estimates that 235 million people have asthma worldwide. In the UK approximately 5.4 million people (1.1 million children and 4.3 million adults) currently get treatment for asthma.
Asthma is a chronic inflammatory respiratory disease, but many diseases present with symptoms similar to those seen in asthma, making diagnosis a challenge for healthcare professionals. In fact, studies of adults diagnosed with asthma suggest that up to 30% do not have clear evidence of asthma* Some may have had asthma in the past, but it is likely that many have been given an incorrect diagnosis. Conversely, other studies suggest that asthma may be underdiagnosed in some cases. Understanding whether airway inflammation is present can help rule out these conditions and support a diagnosis of asthma.
During inflammation, higher-than-normal levels of nitric oxide (NO) are released from epithelial cells of the bronchial wall. The concentration of NO in exhaled breath, or fractional exhaled nitric oxide (FeNO), can help identify airway inflammation, and thereby support a diagnosis of asthma when other objective evidence is lacking.
The new NICE guidelines* issued today recommend the use of FeNO testing as part of comprehensive diagnostic algorithms for adults, children and young people. In particular, NICE recommends FeNO testing for adults when a diagnosis of asthma is being considered, and consideration of a FeNO measurement in children and young people if there is diagnostic uncertainty after initial assessment and normal spirometry, or obstructive spirometry with negative bronchodilator reversibility. Additionally, the health economic model included in the guidelines concluded that FeNO testing was part of the most cost-effective diagnostic pathway for adults. Regarding monitoring of asthma control, it was also noted that FeNO should be considered as an option for patients who remain symptomatic on inhaled corticosteroids as a method to support asthma management.
Circassia's NIOX® products are novel point-of-care FeNO measurement devices, which are available in many countries across Europe, including the UK, as well as the United States, China, Japan and a range of other territories.
Marc Massanari, Vice President of Medical Affairs said: "We are delighted that NICE has recognised the clinical value of FeNO testing in the diagnosis of asthma and its role in providing an objective measure of airway inflammation. Furthermore, NICE has provided compelling evidence that supports the cost effectiveness of incorporating FeNO into diagnostic algorithms for asthma."
Carol Stonham, Senior Nurse Practitioner Respiratory at Gloucestershire CCG, said: "FeNO testing is a very useful part of the jigsaw when a diagnosis of asthma is not clear. It provides useful additional evidence about eosinophilic airway inflammation which supports diagnosis and engages and educates the patient in the journey of a long-term condition. It also gives confidence to both health care professional and patient when considering a step down in treatment and can be a helpful conversation opener into issues around poor compliance with inhaled corticosteroids. "
Asthma is a common, chronic inflammatory respiratory disease that often begins in childhood, but can affect people of any age. The disease is characterised by attacks (exacerbations) of breathlessness and wheezing of varying severity and frequency, which if left untreated can be life-threatening.
Circassia's NIOX® products are used to assist asthma management around the world. Circassia markets NIOX® directly to healthcare professionals in the United States, United Kingdom and Germany and through a network of distributors in a range of other countries.
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. In addition to its market-leading NIOX® products, the Company recently established a collaboration with AstraZeneca in the US in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the US commercial rights to late-stage COPD product Duaklir®.
Circassia's development pipeline includes a range of respiratory medicines. The Company's lead asthma treatment targets substitution of GSK's Flixotide® pMDI and was approved in the UK. Circassia is also developing a direct substitute for Seretide® pMDI, and its pipeline includes a number of inhaled medicines for COPD, including single and combination dose products. For more information on Circassia please visit http://www.circassia.com.
This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as "may", "will", "should", "expect", "anticipate", "project", "estimate", "intend", "continue", "target" or "believe" and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.
*Asthma: diagnosis and monitoring of asthma in adults, children and young people. National Guideline Centre. Commissioned by the National Institute for Health and Care Excellence. November 2017.
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