FDA website posts Duaklir NDA approval

RNS Number : 5475U

Circassia Pharmaceuticals Plc

29 March 2019

 

Circassia Notes FDA Website Posting of Duaklir® in Approvals Section

Oxford, UK - 29 March 2019: Circassia Pharmaceuticals plc ("Circassia" or "the Company"; LSE: CIR), notes the US Food and Drug Administration (FDA) website includes Duaklir® as an FDA approved drug product with an action date of 29 March 2019.  Circassia and AstraZeneca are seeking confirmation from FDA and intend to update the market as soon as possible with further details.

Contacts

Circassia

Steve Harris, Chief Executive Officer                                                                       Tel: [phone]

Julien Cotta, Chief Financial Officer

Rob Budge, Corporate Communications

Peel Hunt (Nominated Adviser and Joint Broker)

James Steel / Dr Christopher Golden                                                                      Tel: [phone]

Numis Securities (Joint Broker)

James Black / Freddie Barnfield                                                                             Tel: [phone]

FTI Consulting

Simon Conway / George Kendrick                                                                          Tel: [phone]

About Circassia

Circassia is a world-class specialty pharmaceutical business focused on respiratory disease.  The Company sells its novel, 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.

 

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