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Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application

Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application

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Treatment for Chronic Obstructive Pulmonary Disease

Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application

Oxford, UK – 1 June 2018 Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Duaklir® Pressair® for the treatment of chronic obstructive pulmonary disease (COPD).

Steve Harris, Circassia’s CEO, said: “The regulatory submission for Duaklir represents a major milestone for Circassia, coming just one year after we established our transformational collaboration for their commercialisation with AstraZeneca. We believe that Duaklir®, if approved, has the potential to provide an important treatment option for the significant number of patients with COPD in the United States.

About Duaklir Pressair

Duaklir is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium and the long-acting beta agonist (LABA) formoterol. It is administered twice daily via the easy-to-use, breath-actuated, multi-dose inhaler, Pressair®. The product is approved in approximately 50 countries worldwide, including in the European Union, under a number of brand names. In April 2017, Circassia and AstraZeneca established a commercial collaboration in the United States under which Circassia has exclusive US commercialisation rights to Duaklir® and AstraZeneca is responsible for the product’s development and regulatory submission.

The Duaklir® NDA is supported by a broad clinical database, and includes data from the AMPLIFY study, results from two previous Duaklir® phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.

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. In 2017, the Company established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza®, and has the commercial rights to NDA-stage COPD product Duaklir®. 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.

Source: Circassia Pharmaceuticals plc

Posted: June 2018

Duaklir (aclidinium bromide and formoterol fumarate) FDA Approval History

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