Eziclen® / Izinova® a New Product for Bowel Cleansing Successfully Completed
European Decentralised Registration Procedure
The launch of Braintree’s drug is expected by end 2013
BRAINTREE, Mass. & PARIS -- February 7, 2013
Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical
group and Braintree Laboratories, Inc., a US-based company specializing in the
development, manufacturing and marketing of specialty pharmaceuticals
announced today that Eziclen^® / Izinova^® (BLI-800)^1 successfully completed
its European decentralized registration procedure involving sixteen countries.
The product will be indicated in adults for bowel cleansing prior to any
procedure requiring a clean bowel (e.g. bowel visualization including bowel
endoscopy and radiology or surgical procedure).
Each Member States [France (reference member state), Belgium, Czech Republic,
Estonia, Germany, Greece, Italy, Latvia, Lithuania, Luxemburg, the
Netherlands, Poland, Portugal, Romania, Spain and UK] should now adopt a
national decision within 30 days. In practice the grant of the national
marketing authorization may vary from one to several months.
Jean Fabre, Senior Vice-President Intercontinental Operations and Franchise
“Primary Care”, Ipsen stated: “The completion of the decentralized procedure
for Eziclen^®/Izinova^® (BLI-800) is an important step forward to national
marketing authorizations in Europe. The availability of Eziclen^®/Izinova^®
(BLI-800) will provide physicians and patients with a valuable agent for
pre-colonoscopy colonic cleansing, particularly in the screening of colorectal
cancer. This decision gives also perspectives for our plant in Dreux where
Eziclen^®/Izinova^® will be manufactured.”
Harry Keegan, President of Braintree Laboratories, Inc. stated: “Braintree
looks forward to the introduction of this important product to European
physicians and patients. Braintree is excited and enthusiastic to continue our
relationship with Ipsen..
About the condition
Colorectal cancer is the second leading cause of cancer-related deaths in
Western countries. Colorectal-cancer mortality and incidence are reduced with
survey programs, and colonoscopy is recommended in that objective. The quality
of bowel cleansing is key for the efficiency of colonoscopy (detection rate),
as well as other visualization techniques (videocapsule) and current
endoscopic therapies as polypectomy, endoscopic mucosal resection.
About Eziclen^® / Izinova^®
Eziclen^® / Izinova^® a new bowel cleansing preparation, is a sulphate-based
formulation (sodium, magnesium and potassium sulphates).
*The clinical efficacy and safety of Izinova^® / Eziclen^® was demonstrated
in two randomized, actively-controlled (versus a 2-liter polyethylene
glycol (PEG) plus electrolytes solution), multi-centre,
investigator-blinded phase III pivotal clinical trials which confirmed the
non-inferiority of BLI-800 versus the comparator with regards to the bowel
*The dose for cleansing the colon will require two administrations of about
0.5 litre / 16 ounces of the product diluted in water, each followed by
about 1 litre / 32 ounces, of clear liquids, each.
Izinova^® / Eziclen^® (BLI800) was developed in the USA by Braintree and has
been approved by the FDA since 2010. Launched in the US in September 2010,
BLI800 (SUPREP^® Bowel Prep Kit) has gained acceptance in the hyper
competitive U.S. colonoscopy preparation market.
About the agreement between Ipsen and Braintree
In 2009, Ipsen acquired the exclusive manufacturing, marketing and
distribution rights of Braintree’s proprietary formulation BLI-800. The
agreement covers countries within the European Union, Commonwealth of
Independent States, selected Asian countries (including China) and some North
Braintree is a United States based specialty pharmaceutical company formed in
1982. Braintree has been an innovative development company which has developed
drugs in gastroenterology, nephrology, primary care and pediatrics. The
company has commercial operations in the United State including development,
manufacturing and sales. Braintree works through licensees and distributors
outside the United States.
Ipsen is a global specialty-driven pharmaceutical company with total sales
exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in
specialty healthcare solutions for targeted debilitating diseases. Its
development strategy is supported by 3 franchises: neurology, endocrinology
and uro-oncology. Moreover, the Group has an active policy of partnerships.
Ipsen's R&D is focused on its innovative and differentiated technological
platforms, peptides and toxins. In 2011, R&D expenditure totalled more than
€250 million, above 21% of Group sales. The Group has total worldwide staff of
close to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service
de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen
has implemented a Sponsored Level I American Depositary Receipt (ADR) program,
which trade on the over-the-counter market in the United States under the
symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are
based on the Group’s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. All of the above risks could affect the Group’s future
ability to achieve its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Moreover, the targets described in this document were prepared without taking
into account external growth assumptions and potential future acquisitions,
which may alter these parameters. These objectives are based on data and
assumptions regarded as reasonable by the Group. These targets depend on
conditions or facts likely to happen in the future, and not exclusively on
historical data. Actual results may depart significantly from these targets
given the occurrence of certain risks and uncertainties, notably the fact that
a promising product in early development phase or clinical trial may end up
never being launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. The Group must face or might face
competition from Generics that might translate into a loss of market share.
Furthermore, the Research and Development process involves several stages each
of which involves the substantial risk that the Group may fail to achieve its
objectives and be forced to abandon its efforts with regards to a product in
which it has invested significant sums. Therefore, the Group cannot be certain
that favourable results obtained during pre-clinical trials will be confirmed
subsequently during clinical trials, or that the results of clinical trials
will be sufficient to demonstrate the safe and effective nature of the product
concerned. The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the Group’s
activities and financial results. The Group cannot be certain that its
partners will fulfil their obligations. It might be unable to obtain any
benefit from those agreements. A default by any of the Group’s partners could
generate lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to update or
revise any forward looking statements, targets or estimates contained in this
press release to reflect any change in events, conditions, assumptions or
circumstances on which any such statements are based, unless so required by
The Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés Financiers.
^1 The drug will be registered under the trade name Eziclen^® in the large
majority of the concerned EU countries and under the name Izinova^® in the
other few countries including France & UK
Vice President, Public Affairs and Corporate Communications
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