Ipsen: Increlex(R) Receives CHMP Positive Opinion for the Treatment of Severe Primary IGF-1 Deficiency



    Regulatory News:

    Upon marketing authorization, Increlex(R) will be commercialized
    in the European Union by Ipsen, Tercica's partner

    Ipsen (Paris:IPN), today announced that the Committee for
    Medicinal Products for Human Use (CHMP) of the European Medicines
    Agency (EMEA) adopted a positive opinion recommending marketing
    authorization for Increlex(R) (mecasermin) 10 mg/ml solution for
    injection. This decision follows Tercica's filing of an application
    for marketing authorisation for Increlex(R) in the European Union on
    December 2005. The indication recommended is for the long-term
    treatment of growth failure in children and adolescents with severe
    primary insulin-like growth factor-1 deficiency (severe primary IGFD),
    and in children with growth hormone (GH) gene deletion who have
    developed neutralizing antibodies to GH.

    Based on an acceptance of the CHMP positive opinion by the
    European Commission, Tercica (Nasdaq: TRCA) expects a marketing
    authorization in two to three months and because Increlex(R)
    previously received Orphan Drug Designation in the European Union,
    this will provide ten years of marketing exclusivity for the treatment
    of severe Primary IGFD. Upon marketing authorization, Ipsen expects to
    pay to Tercica a milestone payment of EUR 15 million (approximately
    US$20 million) under the companies' licensing agreement. Following
    local pricing reviews, Ipsen will market Increlex(R) in the European
    Union.

    Christophe Jean, Executive Vice-President and Chief Operating
    Officer of Ipsen, and Tercica's Board member, said "We are very
    pleased with the CHMP's positive opinion regarding Increlex(R), a very
    innovative product for the treatment of growth failure in patients
    with severe primary IGFD. The addition of Increlex(R) to Ipsen's
    existing global endocrinology portfolio, which also includes
    Somatuline(R) and NutropinAq(R) further reinforces the company's
    global franchise in this high-growth therapeutic area. Ipsen's growing
    endocrinology franchise is giving to endocrinologists a comprehensive
    solution to treat patients suffering from growth disorders."

    About the CHMP's opinion

    (CHMP press release can be accessed at http:///www.emea.europa.eu)

    The CHMP's positive opinion was based on clinical data from 76
    patients who were treated with Increlex(R) for up to 12.5 years. The
    primary endpoint in the pivotal clinical study was height velocity,
    which increased from an average of 2.8 cm per year at baseline to an
    average of 8.0 cm per year (pless than 0.0001) in the first year of
    treatment.

    The summary of product characteristics underlying the CHMP opinion
    defines severe Primary IGFD as:

    -- a height standard deviation score (less than or =) -3.0,

    -- basal IGF-1 levels below the 2.5th percentile for age and
    gender,

    -- GH sufficiency, and

    -- the exclusion of secondary forms of IGF-1 deficiency, such as
    malnutrition, hypothyroidism, or chronic treatment with
    pharmacologic doses of anti-inflammatory steroids.

    The CHMP recommended that the diagnosis be confirmed by conducting
    an IGF-1 generation test.

    About Increlex(R)

    The active ingredient of Increlex(R) is recombinant human
    insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of
    growth hormone's effect on statural growth, and must be present for
    normal growth of bones and cartilage in children. In severe primary
    IGFD, children's serum IGF-1 levels are low, despite the presence of
    normal or elevated GH level. Without adequate IGF-1, children cannot
    achieve normal height. In children with this disorder, low IGF-1
    levels are due to growth hormone resistance associated with mutations
    in GH receptors, post-GH receptor signaling pathways, or to defects in
    IGF-1 gene expression. As such, these children cannot be expected to
    respond adequately to exogenous GH treatment. Some individuals may
    also have a range of metabolic disorders, including lipid
    abnormalities, decreased bone density, obesity and insulin resistance.

    Increlex(R) has been marketed in the United States by Tercica,
    Inc. since early 2006.

    Exclusive rights to develop and commercialize Increlex(R) were
    licensed to Ipsen in October 2006 for all regions of the world except
    the United States, Japan, Canada, Taiwan and certain countries of the
    Middle East and North Africa.

    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 short stature and other
    metabolic disorders. For further information on Tercica, please visit
    www.tercica.com.

    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 (Ipsen)

    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.

    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.

    Forward Looking Statements (Tercica)

    Except for the historical statements contained herein, this press
    release contains forward-looking statements concerning Tercica's
    prospects and expectations, including without limitation, that: (A)
    Increlex will receive ten years of EU orphan drug marketing
    exclusivity for the treatment of severe Primary IGFD; (B) Tercica
    expects to receive a marketing authorization from the European
    Commission in two to three months; (C) Tercica expects to receive a
    milestone payment of EUR 15 million (approximately US$20 million) from
    Ipsen; and (D) Ipsen will launch Increlex in the European Union.
    Because Tercica's forward-looking statements are subject to risks and
    uncertainties, there are important factors that could cause actual
    results to differ materially from those in the forward-looking
    statements. These factors include, without limitation, risks and
    uncertainties related to the following: (i) the European Commission
    may not accept the CHMP opinion, issue a marketing authorization,
    and/or may not issue it in two to three months; and (ii) the risks and
    uncertainties disclosed from time-to-time in reports filed by Tercica,
    including most recently Tercica's Form 10-Q for the quarter ending
    March 31, 2007 filed with the SEC on May 4, 2007. Tercica disclaims
    any obligation or undertaking to update or revise any forward-looking
    statements contained in this press release.