CIR.L Regulatory News (CIR)

Circassia Announces European Launch of NIOX VERO® Nasal Mode for Screening of Primary Ciliary Dyskinesia

Oxford, UK - 12 September 2017: Circassia Pharmaceuticals plc ("Circassia" or "the Company"; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the European launch of the NIOX VERO® nasal application for the screening of primary ciliary dyskinesia (PCD). Circassia launched the application at the world's largest meeting of respiratory professionals, the European Respiratory Society (ERS) 2017 International Congress in Milan, Italy.

At the ERS conference, Circassia hosted a NIOX® workshop at which opinion leaders presented the use of nitric oxide as a biomarker in the diagnosis and management of respiratory diseases. The presentations focused on the clinical use of fractional exhaled nitric oxide (FeNO) in asthma and the role of nasal nitric oxide (nNO) in diagnosing PCD. Circassia also hosted an exhibition booth at the conference, demonstrating the use of NIOX VERO® in both these applications. In addition, Circassia presented data from its recently completed study comparing nNO levels of known PCD subjects with healthy subjects. This study, which enrolled approximately 160 subjects, demonstrated the ability of NIOX VERO® to differentiate between the two groups. Following the completion of the study in H2 2016, Circassia finalised nNO measurement software for the NIOX VERO® and associated nasal sampling kits, and recently completed the European certification for this new application.

Steve Harris, Circassia's CEO, said: "We are delighted to launch the new nasal application for NIOX VERO® to help European specialists diagnose primary ciliary dyskinesia. This life-long condition can lead to permanent lung damage and early diagnosis and treatment is important. However, diagnosis can be difficult currently, and we look forward to helping physicians improve the process for patients with this challenging condition."

About primary ciliary dyskinesia

The prevalence of primary ciliary dyskinesia (PCD) is difficult to estimate accurately, with studies suggesting it may affect 50,000 people in Europe. The condition is characterised by chronic respiratory tract infections, and sufferers often have constant nasal congestion and a chronic cough. Additionally, people with PCD may have abnormally positioned internal organs, hearing problems and infertility. Diagnosis can be complex and can include the use of genetic testing and airway cilia biopsy. However, most people with PCD have unusually low levels of nasal nitric oxide and Circassia has adapted its NIOX VERO® system to accurately measure this exhaled gas to assist the diagnosis of this genetic condition.

About Circassia

Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom and Germany, and in a wide range of other countries through its network of partners. 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.

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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.