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Launch of Ipsen’s Decapeptyl(R) 6-Month Formulation (LP 22.5 mg) in France for the Treatment of Locally Advanced or Metastatic Hormone-Dependent Prostate Cancer

February 4, 2010

PARIS and LAUSANNE, Switzerland, February 4 /PRNewswire/ — Ipsen
(Euronext: FR0010259150; IPN), an innovation-driven global specialty
pharmaceutical group and Debiopharm Group (Debiopharm), a Swiss-based global
biopharmaceutical group of companies with a focus on the development of
prescription drugs that target unmet medical needs, announce the launch by
Ipsen in France of Decapeptyl(R) LP 22.5 mg 6-month sustained-release
formulation for the treatment of locally advanced or metastatic
hormone-dependent prostate cancer. Other launches are planned shortly,
notably in Germany and Portugal.

The marketing authorisation (MA) to this 6-month sustained-release
formulation of Decapeptyl(R) (triptorelin embonate[1] 22.5 mg) was granted on
10 November 2009 by the French regulatory authorities (Agence Francaise de
Securite Sanitaire des Produits de Sante, AFSSAPS) for the treatment of
locally advanced and metastatic hormone-dependent prostate cancer. France was
the first country to approve Decapeptyl(R) LP 22.5 mg in the context of a
Decentralised Procedure in Europe. The reimbursement rate by Social Security
and price setting decision have been published in the Journal Officiel of 3
February 2010
, i.e. less than three months after MA was granted.

Decapeptyl(R) LP 22.5 mg is the new sustained-release 6-month formulation
of a gonatropin- releasing hormone (GnRH) agonist analogue developed by
Debiopharm Group. Debiopharm has licensed the marketing rights to Ipsen for
all territories where Ipsen currently commercialises triptorelin.

On 13 October 2009, Ipsen and Debiopharm Group announced the successful
completion of the European decentralised registration procedure involving
nine countries: Germany (reference member state), France, Austria, Finland,
Norway, Belgium, Denmark, Spain and The Netherlands while for other European
countries (Portugal, United Kingdom, Ireland, Italy, Romania and Lithuania),
the marketing authorisation applications were filed as national line
extensions to the existing Decapeptyl(R)’s ones.

About Decapeptyl(R)

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl(R) is available in 1- and 3-month sustained-release
formulations, as well as a daily formulation. Debiopharm developed and
registered the 1- and 3-month sustained release formulations of triptorelin
embonate in Europe and the U.S. The active substance in Decapeptyl(R) is
triptorelin, a decapeptide analogue of GnRH (Gonadotropin Releasing Hormone),
a hormone secreted by the hypothalamus, which initially stimulates the
release of pituitary gonadotropins (hormones produced by the pituitary
gland), which in turn control hormonal secretions by the testes and ovaries.

The product is now marketed worldwide for the treatment of advanced
prostate cancer, endometriosis, uterine fibroids, precocious puberty, and
female infertility as part of in-vitro fertilisation programs.

The marketing authorisation application for the 6-month-formulation was
submitted to the registration authorities of nine European countries in
September 2008, in accordance with the Decentralised Procedure. It was
supported by data from a phase III study on the efficacy, pharmacokinetics
and safety of two consecutive injections of triptorelin 6-month-formulation
in 120 patients with advanced prostate cancer. The results showed that 97.5%
of patients achieved castrate levels of serum testosterone (defined as less
than or erqual to 1.735nmol/L or 50 ng/dL) 28 days after the first injection,
and 93.0% of the patients maintained castrate levels of testosterone from
week 8 to 48. Furthermore, at months 6 and 12, 98.3% of the patients were
castrated. Overall the phase III data demonstrated that the treatment was
well tolerated. The local tolerance of the product was very good with few
patients (6.7%) experiencing local side effects, the majority of them being
mild. These efficacy and safety results are similar to those obtained
previously with repeated administrations of the 1- and 3-month-formulations
of triptorelin.

Debiopharm will manufacture the 6-month formulation at Debio R.P., its
FDA-inspected production facility in Switzerland.

About Ipsen

Ipsen is an innovation-driven global specialty pharmaceutical group with
over 20 products on the market and a total worldwide staff of nearly 4’200.
Its development strategy is based on a combination of specialty medicine,
which is Ipsen’s growth driver, in targeted therapeutic areas (oncology,
endocrinology, neurology and haematology), and primary care products which
contribute significantly to its research financing. The location of its four
Research & Development centres (Paris, Boston, Barcelona, London) and its
peptide and protein engineering platform give the Group a competitive edge in
gaining access to leading university research teams and highly qualified
personnel. More than 800 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. This strategy is also
supported by an active policy of partnerships. In 2008, Research and
Development expenditure was about EUR183 million, close to 19% of
consolidated sales, which amounted to EUR971 million while total revenues
exceeded EUR1 billion. Ipsen’s shares are traded on Segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150). Ipsen’s shares are eligible
to the “Service de Reglement Differe” (“SRD”) and the Group is part of the
SBF 120 index. For more information on Ipsen, visit our website at
http://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. 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. Notably, future currency
fluctuations may negatively impact the profitability of the Group and its
ability to reach its objectives. Actual results may depart significantly from
these targets given the occurrence of certain risks and uncertainties. The
Group does not commit nor gives any guarantee that it will meet the targets
mentioned above. 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 Autorite
des Marches Financiers.

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group of
companies with a focus on the development of prescription drugs that target
unmet medical needs. The group in-licenses promising biological and small
molecule drug candidates. It develops its products for global registration
and maximum commercial potential. Once registered, the products are
out-licensed to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its
products while providing expertise in pre-clinical and clinical trials,
manufacturing, drug delivery and formulation, and regulatory affairs.

    For more information on Debiopharm Group, please visit:

http://www.debiopharm.com

    For further information:

    Ipsen
    Media
    Didier Veron
    Director, Public Affairs and Corporate Communications
    Tel.: +33-(0)1-58-33-51-16
    Fax:  +33-(0)1-58-33-50-58
    E-mail: didier.veron@ipsen.com

    Financial Community
    David Schilansky
    Investor Relations and Financial Officer
    Tel.: +33-(0)1-58-33-51-30
    Fax:  +33-(0)1-58-33-50-63
    E-mail: david.schilansky@ipsen.com

    Pierre Kemula
    Investor Relations Manager
    Tel.: +33-(0)1-58-33-60-08
    Fax:  +33-(0)1-58-33-50-63
    E-mail: pierre.kemula@ipsen.com

    Debiopharm
    Debiopharm S.A. Contact
    Maurice Wagner
    Director Corporate Affairs & Communication
    Tel.: +41-(0)21-321-01-11
    Fax:  +41-(0)21-321-01-69
    mwagner@debiopharm.com

    Additional Media Contacts
    In London
    Maitland
    Brian Hudspith
    Tel: +44-(0)20-7379-5151
    bhudspith@maitland.co.uk

    New York
    Russo Partners, LLC
    Martina Schwarzkopf, Ph.D.
    Account Executive
    Tel: +1-212-845-4292
    Fax: +1-212-845-4260
    martina.schwarzkopf@russopartnersllc.com

    ---------------------------------
    [1] triptorelin embonate (INN) = triptorelin pamoate (USAN)

SOURCE Debiopharm Group


Source: newswire