Circassia Announces Duaklir® US Launch at American College of Chest Physicians’ CHEST Annual Meeting 2019

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– Duaklir® launch expands Circassia’s US portfolio of COPD products alongside Tudorza® –

Oxford, UK and Morrisville, NC, United States – 21 October 2019: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the US launch of Duaklir® for the maintenance treatment of chronic obstructive pulmonary disease (COPD) at the American College of Chest Physicians’ CHEST Annual Meeting 2019, which is currently ongoing in New Orleans, LA.

Duaklir® is a fixed-dose LAMA / LABA combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and long-acting beta-agonist (LABA) formoterol fumarate administered twice-daily via the breath-actuated, multi-dose inhaler Pressair®. Circassia will promote Duaklir® in the United States via its dedicated COPD sales force, alongside its established COPD treatment Tudorza® (aclidinium bromide).

Duaklir® has been approved by the United States Food and Drug Administration based on a broad clinical database. This includes data from three phase III studies, ACLIFORM, AUGMENT and AMPLIFY, and the phase IV ASCENT study, which shows aclidinium therapy is effective at reducing COPD exacerbations.  As part of its Duaklir® launch activities at the CHEST Annual Meeting 2019, Circassia hosted a Respiratory Educational Reception.  This brought together posters presented at major scientific meetings in the United States and Europe detailing results from the AMPLIFY and ASCENT studies.

Steve Harris, Circassia’s Chief Executive, said: “The US launch of Duaklir® represents a major strategic milestone for Circassia, significantly boosting our portfolio of marketed respiratory products and strengthening our offering of COPD treatments alongside our aclidinium monotherapy, Tudorza®. With the LAMA / LABA market predicted to grow strongly in the United States in the coming years, Duaklir® has the opportunity to make an important contribution to the treatment of this serious disease.  We look forward to our dedicated COPD commercial team successfully introducing this new therapeutic option, as we make Duaklir® available across the United States.”

About COPD
COPD (chronic obstructive pulmonary disease) is a progressive life-threatening lung disease associated primarily with tobacco smoke, with other risk factors including exposure to air pollution or occupational dusts and fumes. The most common symptoms of COPD are breathlessness, chronic cough and mucous production. COPD causes serious long-term disability and early death, and the number of people dying from the disease is growing. According to the American Lung Association, more than 11 million people have been diagnosed with COPD and it is the third leading cause of death from disease in the United States.

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

finnCap (Joint Broker)
Geoff Nash / Alice Lane                                                                                          Tel: +44 (0) 20 7220 0500

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, Germany and Italy, and in a wide range of other countries through its network of partners.  In the United States, Circassia 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 LungFit PH.  For more information please visit www.circassia.com.

Duaklir® and Tudorza® are registered trademarks of Almirall S.A.
Pressair® is a registered trade mark of the AstraZeneca group of companies

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.