Presentation Of Efficacy and Safety Phase III Results by Ipsen´s Partner, Debiopharm, at the 9th International Symposium on GnRH in Berlin (Germany)
Regulatory News:
Ipsen (Paris:IPN) announced that its partner Debiopharm presented
today the results of a phase III study with its new 6-month
formulation of Decapeptyl(R)(1), a luteinizing hormone releasing
hormone agonist (LHRHa) for the treatment of advanced prostate cancer.
The results presented show similar efficacy and safety to the already
marketed 1- and 3-month formulations of triptorelin.
This multicenter, open, non-comparative, phase III study on the
efficacy and safety of two consecutive injections at a six-month
interval of triptorelin 6-month formulation in 120 patients with
advanced prostate cancer, showed that 97.5% of patients achieved
castrate levels of serum testosterone 28 days after the first
injection and that 93% of the patients maintained serum testosterone
levels below castrate level (defined as < 1.735 nmol/L or 50 ng/dL)
from week 8 to 48. These efficacy and safety results are similar to
those obtained previously with repeated administrations of the 1- and
3-month formulations of triptorelin in previous studies. Furthermore,
local tolerance is good with only 6.7% of the patients treated
reporting spontaneously site injection adverse events.
On 31 October 2007, Ipsen exclusively in-licensed from Debiopharm
know-how and new patent applications for the commercialization rights
of Decapeptyl(R) (triptorelin pamoate) in the world excluding North
America, and some other countries (Sweden, Israel, Iran and Japan).
About Decapeptyl(R)
Decapeptyl(R) is a peptide formulation for injection that was
initially developed by Debiopharm and continues to be used mainly in
the treatment of advanced metastatic prostate cancer. Additional
indications developed subsequently include the treatment of uterine
fibroids (a benign tumour of muscle tissues in the uterus),
endometriosis (proliferation of endometrial tissue, the mucous
membrane that lines the uterine wall outside the reproductive tract)
prior to surgery or when surgery is not deemed appropriate, as well as
early onset puberty and female infertility (in vitro fertilisation).
Decapeptyl(R) is available in monthly or quarterly sustained-release
formulations, as well as a daily formulation. The active substance in
Decapeptyl(R) is triptorelin, a decapeptide analogue of GnRH
(Gonadotrophin Releasing Hormone), a hormone secreted by the
hypothalamus, which initially stimulates the release of pituitary
gonadotrophins (hormones produced by the pituitary gland), which in
turn control hormonal secretions by the testes and ovaries.
Decapeptyl(R) was initially launched in France during 1986. At 31
December 2007, Decapeptyl(R) had marketing authorizations in over 60
countries, including 25 in Europe. In 2007, 59.7% of Decapeptyl(R)
sales were generated in the five major European Countries, and reached
a total of 235.1MEUR .
Debiopharm, which holds the patent to pamoate formulations of
Decapeptyl(R) has granted Ipsen an exclusive licence to Decapeptyl(R)
within the European Union (outside Sweden) and in certain other
countries. Debiopharm has also granted Ipsen a co-exclusive licence to
manufacture Decapeptyl(R) within the European Union (outside Sweden)
and in certain other countries (with Debiopharm nonetheless retaining
the right to manufacture and supply Decapeptyl(R) for its own purposes
and those of its other licensees in territories not licensed to the
Group).
About Ipsen
Ipsen is an innovation driven international specialty
pharmaceutical group with over 20 products on the market and a total
worldwide staff of nearly 4,000. The company´s development strategy is
based on a combination of products in targeted therapeutic areas
(oncology, endocrinology and neuromuscular disorders) which are growth
drivers, and primary care products which contribute significantly to
its research financing. This strategy is also supported by an active
policy of partnerships. The location of its four Research and
Development centres (Paris, Boston, Barcelona, London) gives the Group
a competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2006, R&D expenditure was EUR
178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR
861.7 million while total revenues amounted to EUR 945.3 million (in
IFRS). 700 people in R&D are dedicated to the discovery and
development of innovative drugs for patient care. Ipsen´s shares are
traded on Segment A of Eurolist by EuronextTM (stock code: IPN, ISIN
code: FR0010259150). Ipsen´ s shares are eligible to the "Système à
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.
Forward-looking statements
The forward-looking statements and targets contained herein are
based on Ipsen´s management´s 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 Research and Development
process involves several stages at each of which there is a
substantial risk that the Group will fail to achieve its objectives
and be forced to abandon its efforts in respect of 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, or that the regulatory
authorities will be satisfied with the data and information provided
by the Company. Ipsen 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.
Ipsen´s business is subject to the risk factors outlined in its
information documents filed with the French Autorité des Marchés
Financiers.
(1) Triptorelin formulations are mainly sold as Decapeptyl(R),
Diphereline(R) and Pamorelin(R)
