TIDMCIR
RNS Number : 0980K
Circassia Pharmaceuticals Plc
11 December 2018
Circassia to Exercise Option for Full US Commercial Rights to
COPD Treatment Tudorza(R) from AstraZeneca
Oxford, UK - 11 December 2018: Circassia Pharmaceuticals plc
("Circassia" or "the Company"; LSE: CIR), a specialty
pharmaceutical company focused on respiratory disease, today
announces it has issued a notice of option exercise to AstraZeneca
to acquire the full US commercial rights to Tudorza(R)
(aclidinium). Circassia currently promotes the COPD treatment in
the United States under a profit share arrangement established by
the two companies in April 2017. Circassia anticipates completing
the option exercise on 31 December 2018.
Steve Harris, Circassia's CEO, said: "Exercising our option for
the full US commercial rights to Tudorza(R) represents a strategic
opportunity for Circassia. We will have significantly more control
of the product's commercialisation strategy, and with prescription
levels continuing to stabilise, we now have a robust foundation
from which to grow the product. We plan to build on our learnings
of the past 18 months and are launching a dedicated COPD sales
force alongside a focused NIOX(R) team, which we believe will
improve promotion of our existing products and provide a platform
for the launch of Duaklir(R), once approved. With both the
Tudorza(R) option exercise and Duaklir(R) regulatory review process
anticipated to complete in the coming months, we look forward to
2019 with significant optimism."
Option exercise
Under the terms of Circassia's agreement with AstraZeneca,
completion of the option exercise will trigger a payment of $5
million. A deferred Tudorza(R) option payment of $20 million will
be payable upon approval of Duaklir(R) (aclidinium / formoterol),
in addition to deferred consideration of $100 million due under the
companies' agreement. Circassia holds the US commercial rights to
Duaklir(R), and a New Drug Application (NDA) for the product is
currently under review by the FDA with a target completion date of
31 March 2019. The Company anticipates satisfying the option
payments and deferred consideration via third-party funding, or
through a loan facility provided by AstraZeneca under the
companies' agreement if this is unavailable.
Tudorza(R) commercialisation
In the coming weeks, the companies will finalise a transition
plan for the support services, including pharmacovigilance,
regulatory and sales order processing, that AstraZeneca will
continue to provide for a period following completion of the option
exercise before Circassia assumes responsibility for these
activities. Circassia will also retain responsibility for
Tudorza(R)'s promotion and AstraZeneca will continue its
manufacture. Following completion of the option exercise, Circassia
will record Tudorza(R)'s in-market sales and cost of
commercialisation and will retain the full profits.
Tudorza(R) product licence
AstraZeneca is the Tudorza(R) licence holder in the United
States and recently submitted a supplemental NDA requesting
inclusion of positive clinical data from the ASCENT study in the
product's label. The FDA is currently reviewing the filing with a
target action date of 31 March 2019. Following completion of this
review, the Tudorza(R) product licence will be transferred to
Circassia.
Transaction benefits
The option exercise and licence transfer represent an important
opportunity for Circassia. In addition to receiving the economic
benefits of Tudorza(R)'s commercialisation, the Company will have
further flexibility in managing the composition of its sales force,
customer targeting, product detail prioritisation, territory
definition, distribution strategy, pricing and market access
priorities. In preparation, Circassia is launching a dedicated COPD
sales force focused initially on Tudorza(R) and, once approved,
Duaklir(R). In parallel, the Company is establishing a dedicated
NIOX(R) promotional team, which will include a smaller dedicated
sales force supported by telesales and customer service
professionals. The Company believes this structure will improve
targeting and promotional efficiency for its current products and
enhance launch preparations for Duaklir(R).
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
Peel Hunt
James Steel / Christopher Golden Tel: +44 (0) 20 7418 8900
Numis Securities
James Black / 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.
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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