Phase III Clinical Trial with 4-Month Long-Acting Formulation of Triptorelin: Ipsen Decides Not to Perform Further Administration



    Regulatory News:

    Ipsen (Paris:IPN) announced today that the preliminary data from
    the ongoing phase III study for its investigational 4-month
    formulation of triptorelin do not support the expected sustainable
    blood levels of triptorelin for a duration of 4 months in all
    patients. Therefore, Ipsen has decided not to perform the second
    administration as planned in the protocol. No safety concerns have
    been observed throughout the trial. At the end of their respective
    monitoring period, patients will be switched to appropriate approved
    treatment.

    The 4-month investigational product, one of Ipsen's new sustained
    release formulation candidates of triptorelin using one amongst
    several Ipsen proprietary technologies, has shown an adequate efficacy
    and safety profile in phase II allowing a move to phase III. Ipsen's
    goal remains to have a new formulation of triptorelin available when
    the current patents of the 3-month formulation of Decapeptyl(R)
    expire.

    Jacques-Pierre Moreau, Executive Vice-President, Chief Scientific
    Officer of Ipsen said: "We are taking all appropriate actions to solve
    the scale-up issues seen during this phase III, which are inherent to
    advanced formulations based on cutting edge technologies. From the
    onset, the introduction of an innovative subcutaneous presentation
    using a new retro-injection device was well received by patients and
    investigators. Thus, the teams are now focusing their energy and
    expertise in order to resume phase III as soon as possible. Our
    advanced drug delivery platform has already been validated through the
    success of Somatuline(R) Autogel(R), and we are confident in Ipsen's
    ability to have a differentiated formulation of triptorelin."

    About triptorelin

    Triptorelin is a metabolically stabilized analogue of LHRH
    (Luteinizing Hormone Releasing Hormone) an hypothalamic hormone
    secreted in a pulsatile fashion. Upon binding to its pituitary
    receptor LHRH triggers the release of luteinizing hormone, a key
    factor for the regulation of reproductive function. Continuous
    administration of exogenous LHRH or its agonists such as triptorelin
    leads to a rapid desensitization of its pituitary receptor resulting
    in a paradoxical effect that translates into the suppression of
    gonadal steroids such as testosterone and estradiol. This chemically
    induced and reversible castration is of therapeutic benefit in the
    treatment of hormone sensitive tumours such as breast and prostate.
    Triptorelin is the active ingredient of Decapeptyl(R) and
    Diphereline(R) available as 1- and 3-month sustained release
    formulations registered for the treatment of advanced metastatic
    hormone-dependent prostate cancer.

    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.