Regulatory News:
Ipsen (Euronext: FR0010259150; IPN) and Debiopharm Group
(Debiopharm), a global independent biopharmaceutical development
specialist in oncology and serious medical conditions today announced
the extension of their agreement, whereby Ipsen exclusively
in-licenses 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). This new agreement will last for a minimum of
5 years, with a 2 year termination period, after the patent expiry of
the current marketed formulations in July 2010. It further enables
Ipsen to access future sustained-release formulations of
Decapeptyl(R)(1) developed by Debiopharm, among which a 6 month
sustained release formulation that has completed phase III clinical
trials and is expected to be filed by Debiopharm in 2008.
Ipsen will thus be able to propose Decapeptyl(R) in a wider range
of treatment regimens, allowing further adaptation to the therapeutic
needs of cancer patients.
Under the terms of this agreement, the royalties paid by Ipsen to
Debiopharm until July 2010 will remain unchanged. After this date,
Ipsen will continue to pay royalties on its sales of all formulations
of Decapeptyl(R). Ipsen and Debiopharm will share development costs of
the 6 month formulation once it is approved in one major country in
Europe. Ipsen will thereafter exclusively purchase Decapeptyl(R)
(triptorelin pamoate) 6 month from Debiopharm´s cGMP(2) FDA inspected
development and production facility in Martigny, Switzerland, whilst
the royalty rate for the entire franchise will stand in the mid-single
digit range.
Stephane Thiroloix, Executive Vice President, Corporate
Development of Ipsen said "We are very pleased to have extended our
relationship with our long-standing partner Debiopharm. This agreement
should further enable Ipsen to provide patients and physicians with
enhancements to a well-established therapeutic standard. Beyond the
opportunities inherent to this deal, we have now decided to focus our
own current development effort on our in-house sustained release
innovative formulations of triptorelin, capitalizing on our
proprietary technologies and currently in pre-clinical phase, that we
believe will constitute the next generation for this drug."
Kim Bill, Vice President, Corporate Development of Debiopharm
added "Our collaboration with Ipsen has lasted more than 20 years.
This agreement is testament to the excellence of our product,
Decapeptyl(R), Ipsen´s top product, to Debiopharm´s tenacity and
capability in drug development and life cycle management strategies,
as well as the strength of Debiopharm and Ipsen´s relationship.
Debiopharm continues its´ strive for developing excellent drugs
adapted to today´s and tomorrow´s needs."
About Decapeptyl(R)
Decapeptyl(R) is a peptide formulation for injection that was
initially developed 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) is mainly indicated in the
treatment of advanced metastatic prostate cancer. In this indication,
Decapeptyl(R) temporarily increases the concentration of testosterone
and dihydro testosterone, but continuous administration paradoxically
leads to a reduction in plasmatic testosterone concentration. After
two to three weeks´ treatment, testosterone is reduced to levels below
the castration threshold, thereby depriving prostate tumours of one of
the main hormones promoting tumour development. Decapeptyl(R) was
initially launched in France during 1986. At 31 December 2006,
Decapeptyl(R) had marketing authorizations in over 60 countries,
including 25 in Europe. In 2006, 64.4% of Decapeptyl(R) sales were
generated in the five major European Countries. Debiopharm, which
holds the patent to pamoate formulations of Decapeptyl(R) has granted
the Group an exclusive licence to Decapeptyl(R) within the European
Union (outside Sweden) and in certain other countries. Debiopharm has
also granted the Group 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). The pamoate formulations of Decapeptyl(R) (which contributed
66.5% of Decapeptyl(R)´s total sales in 2006) are protected by patents
until 2010 and are composed of monthly and quarterly administration
formulations. The acetate formulations of Decapeptyl(R) (which
contributed 33.5% of Decapeptyl(R)´s total sales in 2006) have no
longer had any patent protection since 2001, with the exception of
France, where an additional certificate of protection expired in
August 2005 and in Italy where an additional certificate of protection
is valid until November 2007. These formulations include daily and
monthly administration formulations.
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 Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen´ s shares are eligible to the "Systeme a
Reglement Differe" ("SRD") and the Group is part of the SBF 250 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. 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
Autorite des Marches Financiers.
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical development
specialist that in-licenses promising biologics and small molecule
drug candidates. Debiopharm develops its products for global
registration and maximum commercial potential for out-licensing 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 three products with global combined sales in
excess of USD 2.6 billion in 2006.
For more information on Debiopharm Group, please visit:
www.debiopharm.com
(1) This agreement refers to triptorelin formulations mainly sold
as Decapeptyl(R), Diphereline(R) and Pamorelin(R)
(2) Current Good Manufacturing Practices
