Ipsen and Medicis announce submission of Reloxin(R) BLA in aesthetics to the FDA



    Regulatory News:

    Medicis (NYSE: MRX) and Ipsen (Euronext: IPN) today announced that
    Ipsen has submitted a Biologics License Application ("BLA") for the
    botulinum toxin type A, Reloxin(R)(1), in aesthetic indications
    (glabellar lines) to the U.S. Food and Drug Administration´s ("FDA")
    Division of Dermatology and Dental Products, within the Center for
    Drug Evaluation and Research. This BLA submission by Ipsen is intended
    to address the concerns cited by the FDA when it declined to file the
    Reloxin(R) BLA in January 2008, which Medicis had submitted in late
    2007. Standard response timeframe from the FDA is expected
    approximately 10 months following receipt of the Reloxin(R)
    submission. Subject to approval of the BLA by the FDA, Medicis intends
    to commercialize Reloxin(R) in the U.S. in accordance with the
    long-standing arrangement between Medicis and Ipsen. Changes from the
    original BLA submission relate primarily to sponsorship and ownership
    of the filing. The substantive elements of the original submission
    remain unchanged.

    Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen,
    said: "We are pleased to have responded to the administrative issues
    raised by the FDA in coordination with Medicis in a timely and
    efficient manner. Together with Medicis, we look forward to working
    diligently with the FDA to obtain a successful marketing approval.
    Given Ipsen´s botulinum toxin positive track record on a global basis,
    we look forward to entering the North American market following FDA
    approval of Reloxin(R)."

    "We are pleased to announce this submission of the BLA for
    Reloxin(R) in aesthetics with FDA," said Jonah Shacknai, Chairman and
    Chief Executive Officer of Medicis. "Both the Ipsen and Medicis teams
    have worked diligently with FDA to determine the best solution for
    submitting Reloxin(R) in aesthetics. We thank everyone involved, and
    extend our appreciation to FDA for its willingness to work with us on
    a resolution in a timely fashion. We continue to believe the
    Reloxin(R) BLA is strong, and anticipate entering in the growing,
    multi-million dollar aesthetic botulinum toxin market in the U.S. upon
    FDA approval."

    In March 2006, Ipsen granted Medicis the rights to develop,
    distribute and commercialize Ipsen´s botulinum toxin product in the
    United States, Canada and Japan for aesthetic use by physicians. Upon
    FDA´s acceptance of the Reloxin(R) submission, Medicis will pay Ipsen
    approximately $25 million in accordance with the agreement between the
    parties.

    According to the American Society for Aesthetic Plastic Surgery,
    injections of botulinum toxin type A were the number one non-surgical
    procedure in 2006, with over 3 million total procedures. Current
    growth estimates in botulinum toxin type A in dollars are estimated to
    be in excess of 20 percent over the prior year. This translates into a
    retail U.S. aesthetic market of approximately $300 million-$400
    million.(2)

    About Ipsen´s Botulinum Toxin Type A

    As of October 2007, Ipsen´s botulinum toxin type A is approved for
    aesthetic indications in 21 countries: Argentina, Australia, Belarus,
    Brazil, Columbia, Ecuador, Egypt, Germany, Honduras, Israel,
    Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Slovak
    Republic, Ukraine, Uruguay, Venezuela, Vietnam, and Russia (in Russia,
    it is the first botulinum toxin type A approved in this field). Ipsen
    is also pursuing regulatory approval for medical indications for the
    product in certain additional key international markets.

    Dysport(R) is a neuromuscular blocking toxin which acts to block
    acetylcholine release, hence reducing muscular spasm and was initially
    developed for the treatment of motor disorders and various forms of
    muscular spasticity, including cervical dystonia (a chronic condition
    in which the neck is twisted or deviated), spasticity of the lower
    limbs (heal) in children with cerebral palsy, blepharospasm
    (involuntary eye closure) and hemifacial spasm. It was later developed
    for the treatment of a wide variety of neuromuscular disorders and
    aesthetic medicine. Dysport(R) was originally launched in the United
    Kingdom in 1991 and has marketing authorisations in over 70 countries
    (at 31 December 2006). Ipsen has just recently filed a BLA for
    Dysport(R) in cervical dystonia to the FDA.

    About Ipsen

    Ipsen is a European 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 R&D centres (Paris, Boston, Barcelona, London) gives the
    Group a competitive edge in gaining access to leading university
    research teams and highly qualified personnel. In 2007, Research and
    Development expenditure was EUR 185 million, in excess of 20% of
    consolidated sales, which amounted to EUR 920.5 million while total
    revenues amounted to EUR 993.8 million (in IFRS). More than 700 people
    in Research & Development 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 "Service de
    Reglement Differe" ("SRD") and the Group is part of the SBF 120 index.
    For more information on Ipsen, visit our website at www.ipsen.com.

    Ipsen 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. The targets contained herein were prepared
    without taking into account external growth assumptions, which may
    alter the parameters. These targets are based on data and assumptions
    regarded as reasonable by the Group and depend on conditions or facts
    likely to happen in the future, and not exclusively on historical
    data. Actual results may depart significantly from the targets given
    the occurrence of certain risks and uncertainties. The Group does not
    commit nor gives any guarantee that it will meet the targets mentioned
    above. 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. Moreover, the targets described in this document were
    prepared without taking into account external growth assumptions,
    which may alter these parameters. These targets are based on data and
    assumptions regarded as reasonable by the Group. These targets depend
    on conditions or facts likely to happen in the future, and not
    exclusively on historical data. Actual results may depart
    significantly from these targets given the occurrence of certain risks
    and uncertainties. The Group does not commit nor gives any guarantee
    that it will meet the targets mentioned above. 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 Medicis

    Medicis is the leading independent specialty pharmaceutical
    company in the United States focusing primarily on the treatment of
    dermatological and aesthetic conditions. The Company is dedicated to
    helping patients attain a healthy and youthful appearance and
    self-image. Medicis has leading branded prescription products in a
    number of therapeutic and aesthetic categories. The Company´s products
    have earned wide acceptance by both physicians and patients due to
    their clinical effectiveness, high quality and cosmetic elegance.The
    Company´s products include the prescription brands RESTYLANE(R)
    (hyaluronic acid), PERLANE(R) (hyaluronic acid), DYNACIN(R)
    (minocycline HCl), LOPROX(R) (ciclopirox), PLEXION(R) (sodium
    sulfacetamide/sulfur), SOLODYN(R) (minocycline HCl, USP) Extended
    Release Tablets, TRIAZ(R) (benzoyl peroxide), LIDEX(R) (fluocinonide)
    Cream, 0.05%, VANOS(R) (fluocinonide) Cream, 0.1%, and ZIANA(R)
    (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL(R)
    (sodium phenylbutyrate) and AMMONUL(R) (sodium phenylacetate/sodium
    benzoate), prescription products indicated in the treatment of Urea
    Cycle Disorder, and the over-the-counter brand ESOTERICA(R). For more
    information about Medicis, please visit the Company´s website at
    www.medicis.com.

    Medicis Forward-Looking Statements

    This press release contains "forward-looking statements" within
    the meaning of the Private Securities Litigation Reform Act. All
    statements included in this press release that address activities,
    events or developments that Medicis expects, believes or anticipates
    will or may occur in the future are forward-looking statements,
    including FDA´s acceptance of the Reloxin(R) submission, the timing
    associated with FDA´s response to the submission and the potential
    commercialization of Reloxin(R). These statements are based on certain
    assumptions made by Medicis based on its experience and perception of
    historical trends, current conditions, expected future developments
    and other factors it believes are appropriate in the circumstances. No
    assurances can be given, however, that these activities, events or
    developments will occur or that such results will be achieved. Such
    statements are subject to a number of assumptions, risks and
    uncertainties, many of which are beyond the control of Medicis.
    Several of these risks are outlined in the Company´s most recent
    annual report on Form 10-K for the year ended December 31, 2007, and
    other documents we file with the Securities and Exchange Commission.
    Forward-looking statements represent the judgment of Medicis´
    management as of the date of this release, and Medicis disclaims any
    intent or obligation to update any forward-looking statements
    contained herein, which speak as of the date hereof.

    NOTE: Full prescribing information for any Medicis prescription
    product is available by contacting the Company. RESTYLANE(R) and
    PERLANE(R) are trademarks of HA North American Sales AB, a subsidiary
    of Medicis Pharmaceutical Corporation. All other marks are the
    property of Medicis or its affiliates.

    (1) The proposed name for the product in the U.S. aesthetic market
    is Reloxin(R), and it is called Dysport(R) for medical and aesthetic
    markets outside the U.S.

    (2) American Society for Aesthetic Plastic Surgery, Cosmetic
    Surgery National Data Bank Statistics, 2006 and Allergan company
    reports