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Debiopharm International SA

Launch of Ipsen's Decapeptyl® 6-month formulation (LP 22.5 mg) in France for the treatment of locally advanced or metastatic hormone- dependent prostate cancer

Paris/Lausanne (ots)

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® 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® (triptorelin embonate[1] 22.5 mg) was 
granted on 10 November 2009 by the French regulatory authorities 
(Agence Française de Sécurité Sanitaire des Produits de Santé, 
AFSSAPS) for the treatment of locally advanced and metastatic 
hormone-dependent prostate cancer. France was the first country to 
approve Decapeptyl® 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® 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®'s ones.
About Decapeptyl®
Debiopharm licensed-in triptorelin from Tulane University in 1982.
Decapeptyl® 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® 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 ? 
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
E183 million, close to 19% of consolidated sales, which amounted to 
E971 million while total revenues exceeded E1 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 
Règlement Différé" ("SRD") and the Group is part of the SBF 120 
index. For more information on Ipsen, visit our website at 
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 Autorité des Marchés 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: 
www.debiopharm.com
[1] triptorelin embonate (INN) = triptorelin pamoate (USAN)

Kontakt:

Ipsen:
Media
Didier Véron
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 Group contacts:
Debiopharm S.A.
Maurice Wagner
Director Corporate Affairs & Communication
Tel.: +41/(0)21/321'01'11
Fax: +41/(0)21/321'01'69
E-Mail: mwagner@debiopharm.com

Additional Media Contacts
In London
Maitland
Brian Hudspith
Tel.: +44/(0)20/7379-5151
E-Mail: 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
E-Mail: martina.schwarzkopf@russopartnersllc.com