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Ipsen and Debiopharm Group Announce That Decapeptyl(R)(triptorelin embonate) 6-month Successfully Completes the European Decentralised Procedure for the Treatment of Locally Advanced or Metastatic Prostate Cancer

October 13, 2009

LAUSANNE, Switzerland and PARIS, October 13 /PRNewswire/ — 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, and Ipsen (Euronext: FR0010259150; IPN), an innovation-driven
global specialty pharmaceutical Group, announced that the 6-month
sustained-release formulation of Decapeptyl(R)[1] (triptorelin embonate[2]
22.5 mg) successfully completed its European decentralised registration
procedure involving nine countries: Germany (reference member state), France,
Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands.

Triptorelin embonate 22.5 mg is Debiopharm’s new 6-month-formulation of a
luteinizing hormone releasing hormone (LHRH) agonist for the treatment of
locally advanced or metastatic, hormone-dependent prostate cancer. Debiopharm
has licensed the European marketing rights to Ipsen. The first European
countries to launch the 6-month formulation should be Germany, The
Netherlands
and Spain.

“As expected, we are proud to offer patients suffering from prostate
cancer a new 6-month formulation of Decapeptyl(R) with an improved
convenience and a consistent and similar efficacy to the already established
1 and 3-month formulations,” said Jean-Luc Belingard, Ipsen’s Chairman and
Chief Executive Officer. “The completion of this procedure represents a major
step forward in the development of our uro-oncology franchise.”

“It is great news that the completion of the European decentralised
procedure for triptorelin embonate 6-month formulation was done in such a
timely manner,” added Rolland-Yves Mauvernay, President and Founder of
Debiopharm Group. “We view this achievement as further evidence of the
efficacy and safety of this important product. LHRH-agonists will remain the
mainstay of hormone-dependent prostate cancer in the years ahead, and
patients can now look forward to receiving a more convenient treatment every
six months instead of every three months.”

About Decapeptyl(R)

Debiopharm licensed-in triptorelin from Tulane University in 1982.

Decapeptyl(R) is available in monthly or quarterly sustained-release
formulations, as well as a daily formulation. Debiopharm developed and
submitted 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, precocious puberty, in-vitro fertilisation
programs, and uterine fibroids.

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 28 days after the
first injection, and 93.0% of the patients maintained castrate levels of
testosterone (defined as less than or equal to 1.735nmol/L or 50ng/dL) from
week 8 to 48. Furthermore, at month 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 results are similar to those obtained previously with
repeated administrations of the 1- and 3-month-formulations of triptorelin.

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.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm
has developed four products with global combined sales of $2.6 billion in
2008.

For more information on Debiopharm Group, please visit:
http://www.debiopharm.com

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, currentt 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 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.

[1] depending on the countries, Ipsen commercialises Decapeptyl(R) under
different brand names (Diphereline(R), Pamorelin(R), Arvekap(R))

    [2] triptorelin pamoate is similar to triptorelin embonate

    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

    In 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

SOURCE Debiopharm Group


Source: newswire



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