TIDMCIR
RNS Number : 2178Y
Circassia Pharmaceuticals Plc
04 December 2017
Circassia Announces Tudorza(R) Successfully Met Both Primary
Endpoints in ASCENT Phase IV Study in Chronic Obstructive Pulmonary
Disease
Ø Significantly reduced COPD exacerbations
Ø Demonstrated favourable cardiovascular safety profile similar
to placebo
Ø Circassia's partner AstraZeneca plans to file data for
inclusion in US label
Oxford, UK - 4 December 2017: Circassia Pharmaceuticals plc
("Circassia" or "the Company"; LSE: CIR), a specialty
pharmaceutical company focused on respiratory disease, today
announces positive top-line results from the ASCENT phase IV
post-marketing study of Tudorza(R)* in over 3,600 patients with
moderate to very severe chronic obstructive pulmonary disease
(COPD) and documented cardiovascular risk factors. The study was
conducted by the Company's partner AstraZeneca. Tudorza(R) contains
the long-acting muscarinic antagonist (LAMA) aclidinium bromide
administered via Pressair(R)** inhaler.
The ASCENT study met its primary efficacy endpoint, with
Tudorza(R) demonstrating statistically significant reductions in
the rate of moderate or severe COPD exacerbations compared with
placebo. In addition, Tudorza(R) met its primary safety endpoint,
demonstrating a favourable cardiovascular safety profile, with the
time to patients experiencing a first major adverse cardiovascular
event similar to placebo. Cardiovascular disease is the most common
and significant comorbidity of COPD. A full evaluation of the
ASCENT data is ongoing and the results will be submitted for
presentation at a forthcoming medical meeting.
Next steps
Under the April 2017 collaboration established between Circassia
and AstraZeneca, Circassia has responsibility for marketing
Tudorza(R) in the United States, and AstraZeneca is responsible for
conducting the product's clinical studies. Following the successful
completion of the ASCENT study, AstraZeneca plans to file a
supplemental New Drug Application (sNDA) with the United States
Food and Drug Administration (FDA) to request inclusion of the
trial data in Tudorza(R)'s label.
Steve Harris, Circassia's Chief Executive, said: "We are
delighted with these positive Tudorza(R) clinical results, which
underline the product's safety and efficacy, particularly in this
important group of at-risk patients. We are highly encouraged with
the progress we are making in our US commercial collaboration with
AstraZeneca, and look forward to our partner filing for an
extension to Tudorza(R)'s label in the coming months."
Steve Lewington, Global Medicine Leader, Respiratory,
AstraZeneca said: "The ASCENT data demonstrate that Tudorza(R),
when added to background therapy, reduces exacerbation rates in
patients with cardiovascular disease or risk factors and adds to
the established efficacy and safety profile of aclidinium bromide.
Based on these results, AstraZeneca plans to submit an sNDA for an
expanded label for Tudorza(R) in the US."
About ASCENT
ASCENT was a double-blind, randomised, placebo-controlled, phase
IV study, which enrolled over 3,600 patients with moderate to very
severe COPD in the United States and Canada. The 36-month study
evaluated the effect of Tudorza(R) (aclidinium bromide 400ug twice
daily via Pressair(R) inhaler) on long-term cardiovascular safety
and COPD exacerbations. The study had two primary outcome
measures:
-- Time to first Major Adverse Cardiovascular Event (MACE).
-- Rate of moderate or severe COPD exacerbations per patient per
year during the first year of treatment.
The study also had a number of secondary endpoints, including
the rate of hospitalisations due to COPD exacerbations and the time
to first MACE or other serious cardiovascular event of
interest.
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.
The Company recently established a collaboration with AstraZeneca
in the US in which it promotes the chronic obstructive pulmonary
disease (COPD) treatment Tudorza(R), and has the US commercial
rights to late-stage COPD product Duaklir(R).
Circassia's development pipeline includes a range of respiratory
medicines. The Company's lead asthma treatment targets substitution
of GSK's Flixotide(R) pMDI and was approved in the UK. Circassia is
also developing a direct substitute for Seretide(R) pMDI, and its
pipeline includes a number of inhaled medicines for COPD, including
single and combination dose products. For more information on
Circassia 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
Ben Atwell / 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)
**Outside of the US the Pressair(R) inhaler is marketed as
Genuair(R)
Tudorza(R), Pressair(R) and Genuair(R) are registered trademarks
of AstraZeneca
This information is provided by RNS
The company news service from the London Stock Exchange
END
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