CIR.L Regulatory News (CIR)

Circassia Welcomes New NICE Guidelines Recommending Use of FeNO Testing in Asthma Diagnosis

Oxford, UK - 29 November 2017: Circassia Pharmaceuticals plc ("Circassia" or "the Company"; LSE: CIR), 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. 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.

The new NICE guidelines* 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.

Steve Harris, Circassia's CEO, said: "We welcome these new NICE guidelines, which highlight the importance of FeNO testing in asthma diagnosis and its role in providing an objective measure of airway inflammation. With asthma diagnosis currently based principally on a thorough history taken by an experienced clinician, we look forward to working closely with healthcare professionals and commissioners to make FeNO testing more widely available."

About asthma

Asthma is a 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. Asthma is a common condition, with the World Health Organisation estimating 235 million people have the condition worldwide. Asthma affects approximately 25 million people in the United States and over 5 million in the UK.

About NIOX®

Th2 or type 2 airway inflammation is the major underlying cause of asthma. NIOX® is based on the discovery that patients with Th2 or type 2 driven airway inflammation generally have higher than normal levels of nitric oxide in their exhaled breath. By measuring the concentration of this fractional exhaled nitric oxide (FeNO), NIOX® enables clinicians to evaluate airway inflammation in patients with underlying asthma. As a result, 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.

About Circassia

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 www.circassia.com.

Forward-looking statements

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.