Ipsen: Clinical Update For Decapeptyl(R) 6-Month Formulation in Advanced Prostate Cancer



    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)