Ipsen: Somatuline(R) Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly



    Somatuline(R) Depot Becomes the First Product Originating from Ipsen's R&D to Be Approved by the FDA and Marketed Globally(1)

    Regulatory News:

    Ipsen (Paris:IPN) today announced that the U.S. Food and Drug
    Administration (FDA) has approved for marketing Somatuline(R) Depot
    (lanreotide) Injection 60, 90 and 120 mg in the United States.

    Somatuline(R) Depot is indicated for the long-term treatment of
    acromegaly in patients who have had an inadequate response to surgery
    and/or radiotherapy, or for whom surgery and/or radiotherapy is not an
    option. Somatuline(R) Depot will be available in a pre-filled syringe
    eliminating any need for reconstitution and thus enabling freedom of
    easy administration to patients.

    In October 2006, Ipsen granted to Tercica the development and
    commercialization rights for Somatuline(R) Depot in the US and Canada.
    At the same time, Ipsen acquired a 25% stake in Tercica on a
    non-diluted basis. According to the terms of the agreement, the FDA
    approval of Somatuline(R) Depot triggers a EUR 30 million milestone
    payment that Tercica will pay to Ipsen by issuing a convertible bond
    (converted into Tercica common stock at a conversion price of EUR
    5.92). Tercica will simultaneously issue an additional $15 million
    convertible bond to Ipsen (converted into Tercica common stock at a
    conversion price of $7.41) which will be paid in cash to Tercica.

    Tercica now expects to launch Somatuline(R) Depot in the United
    States in the fourth quarter 2007.

    Jean-Luc Belingard, Chairman and CEO of Ipsen said "We are very
    proud to be able to announce today that a product originated from
    Ipsen's R&D will be available globally. This is Ipsen's first ever FDA
    approval, a major achievement made possible thanks to the outstanding
    dedication and commitment of our teams. We feel confident that our
    partner Tercica will market Somatuline(R) Depot very successfully by
    offering to patients suffering from acromegaly a new treatment option
    that has been proven to be effective, and very convenient to use. With
    Somatuline(R), Increlex(R), NutropinAq(R) and its very rich pipeline
    of research products, Ipsen confirms its strong commitment to the
    progress of endocrinology worldwide."

    About acromegaly

    Acromegaly is a disorder caused by the over-production of growth
    hormone usually by a benign tumour of the anterior pituitary gland.
    Acromegaly occurs in approximately 60 people per million of
    population. In acromegaly patients, the pituitary gland releases too
    much growth hormone ("GH") into the bloodstream, the GH then triggers
    the liver to produce IGF-1, which in turn directly stimulates bone and
    tissue growth. The most common signs and symptoms of this serious
    condition include: enlarged hands, feet, and head, facial changes such
    as bulging forehead, enlarged lower jaw, tongue and lips, wider
    spacing between teeth, enlarged heart, liver, kidneys, spleen and
    other organs, joint pain and fatigue, reduced sex drive and loss of
    concentration.

    About the approval for marketing

    The summary of the approval for marketing will be accessible at
    http:///www.fda.gov

    This decision follows the filing by Ipsen of a New Drug
    Application (NDA) for Somatuline(R) Depot in the USA in December 2006.
    The effect of Somatuline(R) Depot on reducing GH and IGF-levels and
    control of symptoms in patients with acromegaly was studied in two
    long-term, multiple-dose, randomized multicenter studies performed in
    the United States and in Europe. Somatuline(R) Depot demonstrated its
    ability to decrease the levels of GH and IGF-1 in the majority of
    patients over a one year period.

    About Somatuline(R) Depot and Somatuline(R) Autogel(R)

    Somatuline(R) Depot (also marketed as Somatuline(R) Autogel(R)
    outside the USA) is a sustained-release formulation for injection
    containing lanreotide, a somatostatin analogue (a hormone that
    inhibits the release of growth hormone). Somatuline(R) was initially
    developed and continues to be used mainly in the treatment of
    acromegaly, a disorder caused by the over-production of growth hormone
    or prolactin due to a benign tumour of the anterior pituitary gland.
    This product subsequently underwent further development in Europe in
    the treatment of symptoms associated with neuroendocrine tumours
    (particularly of a carcinoid type). Ipsen believes that the
    Somatuline(R) Autogel(R) formulation, to which it holds the patent,
    represents a major technological advance. As far as the Group is
    aware, this represents the first semi-solid formulation for injection
    without any excipient, since the active substance itself controls the
    sustained release. Somatuline(R) Autogel(R) releases the active
    substance with no excipient other than water over a period of at least
    28 days, thus requiring just one injection per month compared with the
    two or three injections previously necessary. This product is
    presented in a pre-filled syringe for easy administration.

    Active substance

    The active substance in Somatuline(R) and Somatuline(R) Autogel(R)
    is lanreotide, which inhibits the growth and secretion of several
    endocrine, exocrine and paracrine functions. It is particularly
    effective in inhibiting the secretion of growth hormone.

    Indications

    Somatuline(R) is used primarily in the treatment of acromegaly
    when circulating levels of growth hormone remain high despite surgery
    or radiotherapy. Somatuline(R) inhibits growth hormone release and
    thus controls the therapeutic and relieves the symptoms associated
    with elevated levels of this hormone.

    Intellectual property

    Ipsen holds an exclusive worldwide license granted by Tulane
    University (United States) to manufacture, use and market the active
    substance in Somatuline(R) (lanreotide) and is the direct holder of
    the patent covering the Somatuline(R) Autogel(R) or Depot formulation.
    The Group holds patents to the Somatuline(R) Autogel(R) formulation,
    which are set to expire in 2015 in Europe and in the United States.
    The patent protecting the active substance expired in 2006 in the
    United States and expired in December 2005 in Europe, except in
    Belgium, France, Italy, Luxembourg and the United Kingdom where
    additional certificates of protection remain valid until 2009.

    Marketing

    Somatuline(R) Autogel(R) is marketed in almost 60 countries
    (including 26 in Europe) by Ipsen for the treatment of acromegaly and
    neuroendocrine tumours or acromegaly alone. Somatuline had sales of
    EUR 92 million in 2006, out of which 68% were generated in the Major
    Western European Countries (France, Germany, Italy, Spain, United
    Kingdom). Somatuline(R) Autogel(R) accounted for 86% of total sales of
    this product. Somatuline(R) and Somatuline(R) Autogel(R) are
    prescribed mainly by endocrinologists, gastroenterologists,
    oncologists, surgeons and intensive care specialists.

    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 Tercica

    Tercica is a biopharmaceutical company committed to improving
    endocrine health by partnering with the endocrine community to develop
    and commercialize new therapeutics for paediatric and adult growth
    disorders, and for adult metabolic disorders. For further information
    on Tercica, please visit www.tercica.com.

    (1) Somatuline(R) Depot is marketed outside the United States of
    America as Somatuline(R) Autogel(R) with the exception of Japan, where
    the product is developed by Ipsen's partner Teijin and is currently in
    phase II clinical trial.