Ipsen and Medicis Announce Acceptance of Reloxin® BLA in Aesthetics by FDA



    Regulatory News:
    Ipsen (Paris:IPN) and Medicis (NYSE: MRX) today announced that the Food

    and Drug Administration ("FDA")

    has accepted the filing of Ipsen´s Biologics

    License Application ("BLA")

    for Reloxin®, its

    botulinum toxin type A in aesthetic use (glabellar lines) in the United

    States. This acceptance signifies the start of the review process of the

    dossier.
    In accordance with the agreement between the two parties, Medicis will

    pay Ipsen approximately $25 million in connection with the announcement

    made today. Subject to approval of the BLA by the FDA, Medicis will pay

    to Ipsen a further $75 million and will commercialize Reloxin® in the U.S.
    About Ipsen´s Botulinum Toxin Type A
    As of April 2008, Ipsen´s botulinum toxin type

    A, developed in the field of aesthetic medicine in the U.S., Canada and

    Japan under the trademark Reloxin®

    is approved for aesthetic indications in 23 countries: Argentina

    Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, El Salvador

    Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand

    Philippines, Slovak Republic, South Korea, 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® 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® was originally launched in the United Kingdom in 1991 and has

    marketing authorisations in over 70 countries (at 31 March 2008). Ipsen

    has also recently filed a BLA for Dysport® 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 ?185

    million, in excess of 20% of consolidated sales, which amounted to ?920.5

    million while total revenues amounted to ?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 EuronextTM (stock

    code: IPN, ISIN code: FR0010259150). Ipsen´s

    shares are eligible to the "Service de 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.
    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 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 favorable 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. The Group also faces the risk of product liability claims relating

    to their safety, notably for its neuromuscular disorders products

    (marketed under the brand name Dysport® notably) that may cause, or may appear to cause, serious adverse side

    effects or potentially dangerous drug interactions if misused or

    improperly prescribed. The Group is subject to adverse event reporting

    pharmacoviligance obligations that require to report to regulatory

    authorities if the Group´s products are

    associated with serious adverse events, including patient death or

    serious injury. These adverse events, among others, could result in

    additional regulatory constraints, such as additional requests from the

    regulatory authorities during reviews of applications filed for

    marketing approvals in various countries which could delay the launch

    time of the given products in new markets, the performance of costly

    post-approval clinical studies or revisions to the approved labeling

    limiting the indications or patient population for the Group´s

    products or could even lead to the withdrawal of a product from the

    market. Such events could harm the sales of the product and therefore

    have a material negative impact on the Group´s financial situation.

    Furthermore, any adverse publicity associated with such an event could

    cause consumers to seek alternatives to the Group´s

    products, which may cause sales to decline, even if the Ipsen product at

    stake is ultimately determined not to have been the cause of the

    reported serious adverse event. Ipsen´s business is subject to the risk

    factors outlined in its information documents filed with the French Autorité des Marchés 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® (hyaluronic acid), PERLANE® (hyaluronic acid), DYNACIN® (minocycline HCl), LOPROX® (ciclopirox), PLEXION® (sodium sulfacetamide/sulfur), SOLODYN® (minocycline HCl, USP) Extended Release Tablets, TRIAZ® (benzoyl peroxide), LIDEX® (fluocinonide) Cream, 0.05%, VANOS® (fluocinonide) Cream, 0.1%, and ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, BUPHENYL® (sodium phenylbutyrate) and AMMONUL® (sodium phenylacetate/sodium benzoate), prescription products indicated

    in the treatment of Urea Cycle Disorder, and the over-the-counter brand

    ESOTERICA®. 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 the timing

    associated with FDA´s response to the

    submission and the potential commercialization of Reloxin®.

    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® and PERLANE® are

    trademarks of HA North American Sales AB, a subsidiary of Medicis

    Pharmaceutical Corporation. All other trademarks are the property of

    their respective owners.