Circassia Pharmaceuticals Plc Circassia announces FDA approval of Tudorza sNDA (5428U)
March 29 2019 - 11:34AM
UK Regulatory
TIDMCIR
RNS Number : 5428U
Circassia Pharmaceuticals Plc
29 March 2019
This announcement contains inside information for purposes of
Article 7 of Market Abuse Regulation 596/2014
Circassia Announces FDA Approval of Tudorza(R) Supplemental New
Drug Application
Ø Data showing reduction in COPD exacerbations and no increase
in major cardiovascular events vs placebo added to label
Ø Tudorza(R) is the only product in its class with these data in
the label
Oxford, UK - 29 March 2019: Circassia Pharmaceuticals plc
("Circassia" or "the Company"; LSE: CIR), a specialty
pharmaceutical company focused on respiratory disease, today
announces the US Food and Drug Administration (FDA) has approved
Tudorza(R)'s supplemental New Drug Application (sNDA) for the
inclusion of unique new clinical data in the product's label.
Tudorza(R) is indicated for the maintenance treatment of chronic
obstructive pulmonary disease (COPD) and contains the long-acting
muscarinic antagonist (LAMA) aclidinium bromide (400 mcg)
administered twice-daily via the breath-actuated inhaler
Pressair(R).
Tudorza(R)'s expanded label now includes data from the phase IV
ASCENT study, which was conducted in patients with moderate to very
severe COPD and cardiovascular disease and / or significant
cardiovascular risk factors. The study demonstrated that Tudorza(R)
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. Cardiovascular
disease is the most common and significant co-morbidity of COPD,
with approximately 30% of COPD patients dying from cardiovascular
conditions. Tudorza(R) is the only LAMA in the United States with
these data in its label.
Steve Harris, Circassia's Chief Executive, said: "This approval
adds unique new clinical data to Tudorza(R)'s label, which further
differentiates this important COPD treatment option within the $2
billion US LAMA market. Cardiovascular disease is a major
co-morbidity of COPD, and the inclusion of comprehensive data
demonstrating COPD exacerbation reductions and cardiovascular
safety provides physicians with important new information, helping
to further serve this significant patient group. Following our
recent option exercise acquiring the full US commercial rights to
Tudorza(R), and this subsequent label expansion, we look forward to
implementing our strategy targeting product growth in this major
market."
Tudorza(R) is a registered trademark of Almirall S.A.
Pressair(R) is a registered trade mark of the AstraZeneca group
of companies
This announcement contains inside information for the purposes
of Article 7 of the Market Abuse Regulation 596/2014. The person
who arranged for the release of this announcement on behalf of
Circassia was Julien Cotta, Chief Financial Officer.
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 novel,
market-leading NIOX(R) 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(R) and Duaklir(R). 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
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contact rns@lseg.com or visit www.rns.com.
END
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