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Circassia Announces Publication of Tudorza Phase IV ASCENT Study in the Journal of the American Medical Association

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May. 7, 2019

Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the full publication of the Tudorza® phase IV ASCENT study in the prestigious Journal of the American Medical Association*.

The ASCENT study was conducted in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and cardiovascular disease and / or significant cardiovascular risk factors. This patient population is of particular relevance as cardiovascular disease is the most common and significant comorbidity of COPD, with approximately 30% of COPD patients dying from cardiovascular conditions. The ASCENT results demonstrate Tudorza® is effective at reducing COPD exacerbations with no increase in major cardiovascular events, and at reducing hospitalisations due to COPD exacerbations, in this at-risk population.

At the end of March 2019, the FDA approved a supplemental New Drug Application (sNDA) adding these clinical data to Tudorza®’s prescribing information. As a result, Tudorza® is the only long-acting muscarinic antagonist (LAMA) in the United States with COPD exacerbation reduction data and data demonstrating cardiovascular safety in patients with cardiovascular disease / risk factors in its label.

About Circassia
Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. The Company sells its market-leading NIOX® asthma management products directly to specialists in the United States, United Kingdom, China and Germany, and in a wide range of other countries through its network of partners.  In the United States, Circassia has a commercial collaboration with AstraZeneca in which it has the commercial rights to chronic obstructive pulmonary disease (COPD) treatments Tudorza and Duaklir. Circassia also has the US and Chinese commercial rights to the late-stage ventilator-compatible nitric oxide product AirNOvent.

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