Publication of Tudorza Phase IV ASCENT in JAMA

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

Oxford, UK - 8 May 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.

Steve Harris, Circassia's CEO, said: "The publication of these clinical results in the prestigious Journal of the American Medical Association further demonstrates Tudorza®'s safety and efficacy, particularly in this group of at-risk patients.  We are delighted at this recognition of the importance of these data, and of the recent inclusion of this new information in Tudorza®'s prescribing information."

*Wise R et al.  Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients with Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial.  JAMA 2019;321(17):1693-1701.

Contacts

Circassia

Steve Harris, Chief Executive Officer                                                                       Tel: +44 (0) 1865 405 560

Julien Cotta, Chief Financial Officer

Rob Budge, Corporate Communications

Peel Hunt (Nominated Adviser and Joint Broker)

James Steel / Dr Christopher Golden                                                                      Tel: +44 (0) 20 7418 8900

Numis Securities (Joint Broker)

James Black / Freddie Barnfield                                                                             Tel: +44 (0) 20 7260 1000

FTI Consulting

Simon Conway / Ciara Martin                                                                                 Tel: +44 (0) 20 3727 1000

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.  For more information 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.