TIDMCIR
RNS Number : 9346P
Circassia Pharmaceuticals Plc
01 June 2018
Circassia Announces Submission of Duaklir(R) New Drug
Application and Tudorza(R) Supplemental New Drug Application in the
United States
Ø Duaklir(R) NDA for treatment of chronic obstructive pulmonary
disease (COPD)
Ø Tudorza(R) sNDA for inclusion of COPD exacerbation reduction
and cardiovascular safety data in label
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(R)
Pressair(R) for the treatment of chronic obstructive pulmonary
disease (COPD).
The Company also announces the concurrent submission of a
supplemental New Drug Application (sNDA) for Tudorza(R) Pressair(R)
for the inclusion of clinical data demonstrating cardiovascular
safety and reduction of COPD exacerbations in the product's
prescribing information.
Under the Prescription Drug User Fee Act (PDUFA), the review
period for the NDA and sNDA will be confirmed in the Day 74
communication from the FDA.
Steve Harris, Circassia's CEO, said: "The regulatory submissions
for Duaklir(R) and Tudorza(R) represent a major milestone for
Circassia, coming just one year after we established our
transformational collaboration for their commercialisation with
AstraZeneca. We believe that Duaklir(R), if approved, has the
potential to provide an important treatment option for the
significant number of patients with COPD in the United States. In
addition, the positive cardiovascular safety and COPD exacerbation
reduction results achieved in the Tudorza(R) ASCENT study offer the
potential to include unique new information in the product's
prescribing information, if approved."
About Duaklir(R) Pressair(R)
Duaklir(R) 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(R). 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(R) and AstraZeneca
is responsible for the product's development and regulatory
submission.
The Duaklir(R) NDA is supported by a broad clinical database,
and includes data from the AMPLIFY study, results from two previous
Duaklir(R) phase III studies, ACLIFORM and AUGMENT, and
exacerbation data from the ASCENT trial.
About Tudorza(R) Pressair(R)
Tudorza(R) contains the LAMA aclidinium administered twice daily
via the Pressair(R) inhaler. Tudorza(R) was first approved in the
United States in 2012 for use in the treatment of COPD, and under
Circassia's commercial collaboration with AstraZeneca, Circassia is
responsible for the product's promotion and AstraZeneca for
completing its clinical studies and regulatory submissions.
Tudorza(R)'s sNDA includes data from the recently completed
phase IV ASCENT study. The study, which was conducted in patients
with moderate to very severe COPD and cardiovascular disease and /
or risk factors, demonstrated Tudorza(R) is effective at reducing
COPD exacerbations with no increase in cardiovascular events, and
reducing hospitalisations due to COPD exacerbations, in this
at-risk population. If the sNDA is approved, Tudorza(R) will be the
only LAMA in the United States with these data in its label.
About Circassia
Circassia is a world-class specialty pharmaceutical business
focused on respiratory disease. Circassia sells its novel,
market-leading NIOX(R) 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(R), and has
the commercial rights to NDA-stage COPD product Duaklir(R). For
more information please visit www.circassia.com.
Contacts
Circassia
Steve Harris, Chief Executive Officer Tel: +44 (0) 1865 405
560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
JP Morgan Cazenove
James Mitford / James Deal Tel: +44 (0) 20 7742 4000
Numis Securities
Clare Terlouw / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Simon Conway / Mo Noonan Tel: +44 (0) 20 3727 1000
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.
Aclidinium is marketed under a number of brand names around the
world, including Tudorza(R), Eklira(R) and Bretaris(R)
Duaklir(R) is a registered trademark in Europe and other
markets; use of the US trademark is subject to review and approval
by the FDA
Duaklir(R) and Tudorza(R) are registered trademarks of Almirall
S.A.; Pressair(R) is a registered trade mark of the AstraZeneca
group of companies
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
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
REAEAESFDDXPEAF
(END) Dow Jones Newswires
June 01, 2018 02:00 ET (06:00 GMT)
Circassia (LSE:CIR)
Historical Stock Chart
From Apr 2024 to May 2024
Circassia (LSE:CIR)
Historical Stock Chart
From May 2023 to May 2024