Regulatory News:
Ipsen (Paris:IPN) (Euronext: IPN - ADR: IPSEY) acknowledges the French
government’s decision to no longer reimburse Tanakan®,
Tramisal® and Ginkogink®, presently manufactured
at the industrial site of Dreux (France). This decision is linked to the
French policy to reassess the reimbursement of a certain number of drugs
by the French Social Security.
Although Tanakan®, Tramisal® and Ginkogink®
will be delisted from 1st March 2012 onwards, they will
continue to be prescribed and delivered by healthcare professionals to
patients in France.
The decision to delist Tanakan®, Tramisal® and
Ginkogink® underlines the relevance of Ipsen’s strategy to
find a partner for its commercial operations in primary care with an OTX
and OTC experience, as well as an acquirer for its industrial site at
Dreux (France).
About Tanakan® (EGb 761®)
EGb 761®,
which is the active
substance of Tanakan®, is a unique standardized extract of
Ginkgo biloba. This compound features antioxidant and neuroprotective
property as well as an action on ß-amyloid protein in experimental
models. Its consistent composition in pharmacologically active
substances is achieved through specially designed plantations of Ginkgo
biloba (dioecious tree in the Ginkgoaceae family) that are cultivated
under controlled conditions and a standardised extraction and
purification process. EGb 761® is indicated and
registered in many countries notably for the treatment of cognitive
disorders in the elderly as well as neurosensory disorders.
In France, the reimbursement rate for drugs with a low or insufficient
therapeutic value (Service Médical Rendu Faible ou Insuffisant),
including Tanakan®,
was lowered to 15% on 1 April
2010. On January 15th 2011, the French Health Minister
announced a set of new rules on drugs with an insufficient therapeutic
value (Service Médical Rendu Insuffisant) that include Tanakan®:
"In the absence of specific notice from the Health Minister, the social
security will no longer reimburse this class of drugs”.
Sales of Tanakan® in the first nine months of 2011 totaled
€70.6 million of which 50% originated from France. In 2010, sales of
Tanakan® totaled €96.4 million of which 52% originated from
France. Between 2005 and 2010, sales of Tanakan® decreased at
an annual average rate of (10.8%) in France whereas they increased at an
annual average rate of +7.4% in the other markets. The Group plans a
decrease of Tanakan® sales of around 35%1 in
France in 2012. This estimate is based on decreases of sales following
the delisting of veintonics in 2008.
About Ipsen
Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.1 billion in 2010. Ipsen’s ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by four franchises:
neurology / Dysport®, endocrinology / Somatuline®,
uro-oncology / Decapeptyl® and hemophilia. Moreover, the
Group has an active policy of partnerships. R&D is focused on innovative
and differentiated technological patient driven platforms, peptides and
toxins. In 2010, R&D expenditure totaled more than €220 million, above
20% 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’s 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 loose of market shares.
Furthermore, the Research and Development process involves several
stages each of which involve 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
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 applicable law.
The Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers.
For further information:
1 Impact estimated for full year
