Empresas y finanzas

EMEA Recommends Marketing Authorisation of Ipsen´s Adenuric(R) (Febuxostat) for the Treatment of Chronic Hyperuricaemia in Gout

22/02/2008 - 10:20
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    Adenuric(R) Represents the First Major Treatment of Gout for More Than Forty Years

    Regulatory News:

    Ipsen (Paris:IPN) announced today that the Committee for Medicinal
    Products for Human Use (CHMP) of the European Medicines Agency (EMEA)
    provided a positive opinion for Adenuric(R) (febuxostat) 80 mg and 120
    mg tablets for the treatment of chronic hyperuricaemia in gout and
    recommended it for marketing authorisation. The CHMP recommendation
    will now be forwarded to the European Commission for final marketing
    approval, which typically occurs within 60 to 90 days. Following
    marketing approval, Adenuric(R) will become, since 1964, the first
    significant treatment alternative for chronic hyperuricaemia available
    to gout patients.

    Adenuric(R) is to be indicated for the treatment of chronic
    hyperuricaemia for conditions in which urate deposition has already
    occurred (including a history, or presence of, tophus and/or gouty
    arthritis). The detailed recommendations for the use of this product
    will be described in the Summary of Product Characteristics (SPC), to
    be made available after the medication receives marketing
    authorisation from the European Commission.

    Once the product receives its marketing authorisation and its
    price is agreed, Febuxostat will be marketed by Ipsen in France under
    the brand name Adenuric(R). Outside France, the commercialisation of
    the product will be partnered.

    Jean-Luc Belingard, Chairman and Chief Executive Officer of Ipsen,
    said, "We are very proud to receive this positive opinion for
    Adenuric(R) from the EMEA, and look forward to bringing this new
    molecule to market, pending European Commission approval. This
    innovative drug pioneers the first major treatment of gout for more
    than 40 years. It confirms Ipsen´s ability to continue to bring to the
    market important new treatment options for severely debilitating
    diseases."

    About Adenuric(R) (febuxostat)

    Gout, a particularly painful type of arthritis, is the most
    frequent arthritis in men. It is caused by elevated levels of uric
    acid in the body: hyperuricaemia. Febuxostat, an oral, once-daily
    medication, is a novel non-purine, selective inhibitor of xanthine
    oxidase studied for its effects on lowering levels of serum uric acid
    (sUA) in patients with gout. Febuxostat is licensed to Ipsen for
    Europe from Teijin Pharma Limited, Tokyo.

    The EU submission includes two of the largest industry sponsored
    studies to date studying treatment of chronic gout patients. The goal
    of chronic gout treatment is per EULAR guidelines (European League
    Against Rheumatism) to reduce and maintain sUA levels below 6 mg/dL.
    Febuxostat demonstrated superior ability to lower and maintain in
    patients, serum uric acid at a level inferior to 6 mg/dl compared to
    conventionally used doses of allopurinol (febuxostat 80 and 120 mg: 51
    & 63 % resp. vs. allopurinol: 22%). In addition, one phase III study
    showed that gout patients with mild to moderate renal impairment
    (serum creatinine greater than1.5 - <=2.0 mg/dl) had response rate of
    44 and 45 % respectively with febuxostat 80 and 120 mg.

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

    In 2003, Ipsen entered into a Research and Development partnership
    with Teijin Pharma Limited, the core company of Teijin Group´s
    pharmaceutical and home healthcare business. The Teijin group is a
    Japanese industrial conglomerate specialising in the businesses of
    fibres, films, plastics and information technology (IT) as well as
    pharmaceuticals and home healthcare. This partnership covers the
    development and subsequent commercialisation of four of Ipsen´s
    products by Teijin Pharma in Japan and the development and marketing
    by Ipsen in Europe (i.e. European Union and Russia) of febuxostat, a
    product owned by Teijin Pharma and known as TMX-67.

    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 EuronextTM (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 120 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, or that the regulatory
    authorities will be satisfied with the data and information provided
    by the Company. 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.

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