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Home  /   Forum   /   Pharming   /   GTC en EMEA

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

Laatste koers (eur) Verschil Volume
0,874   -0,007   (-0,80%) Dagrange 0,868 - 0,899 5.782.411   Gem. (3M) 6,4M

GTC en EMEA

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5 Posts
| Omlaag ↓
  1. kers 27 februari 2004 14:29
    GTC Biotherapeutics Announces EMEA
    Accepts MAA Submission for Review Of ATryn

    FRAMINGHAM, Mass.--Feb. 27, 2004--GTC Biotherapeutics, Inc.
    ("GTC", Nasdaq: GTCB) announced today that the European Medicines
    Evaluation Agency (EMEA) has accepted for review GTC's Market
    Authorization Application (MAA) submission of ATryn(R), its
    recombinant human antithrombin. With the acceptance of the MAA, the
    EMEA begins its review process to determine if ATryn(R) is acceptable
    for use in Europe as a treatment of hereditary antithrombin
    deficiency.
    "We are very pleased that the EMEA will begin the review process
    for ATryn(R)," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the
    Board and Chief Executive Officer. "We are looking forward to what we
    believe will be a successful conclusion in the review of ATryn(R)."
    GTC recently completed a multinational safety and efficacy study
    of ATryn(R) in the prophylactic treatment of hereditary antithrombin
    deficiency during high risk situations such as surgery and childbirth.
    The MAA submission includes data from this trial as well as data from
    high risk patients treated under a compassionate use program.
    Antithrombin is a plasma protein with anticoagulant and
    anti-inflammatory properties. GTC expresses this protein in the milk
    of goats that have the human antithrombin gene linked to a
    milk-protein promoting gene. This transgenic approach provides the
    opportunity to produce recombinant forms of proteins, such as
    antithrombin, that are difficult to express in conventional production
    methods.
    GTC Biotherapeutics is a leader in the development, production,
    and commercialization of therapeutic proteins through transgenic
    animal technology. GTC has three internal proprietary products in its
    pipeline and a portfolio of external program production opportunities.
    In addition to the ATryn(R) program, GTC is developing a recombinant
    human serum albumin and a malaria vaccine. In its external programs,
    GTC's technology is used to develop transgenic production of its
    partners' proprietary products, including both large-volume protein
    therapeutics as well as products that are difficult to produce in
    significant quantities from conventional bioreactor systems. GTC's
    external program collaborations are developing transgenic versions of
    products such as monoclonal antibodies and immunoglobulin fusion
    proteins for conditions such as rheumatoid arthritis, HIV/AIDS and
    cancer. One of the external programs recently entered clinical trials
    with a transgenically produced product. Additional information is
    available on the GTC web site, www.gtc-bio.com.
    This press release contains forward-looking statements as defined
    in the Private Securities Litigation Reform Act of 1995, including
    without limitation statements regarding the expected outcomes of
    regulatory submissions for the ATryn(R) program. Such forward-looking
    statements are subject to a number of risks, uncertainties and other
    factors that could cause actual results to differ materially from
    future results expressed or implied by such statements. Factors that
    may cause such differences include, but are not limited to, the risks
    and uncertainties discussed in GTC's most recent Annual Report on Form
    10-K and its other periodic reports as filed with the Securities and
    Exchange Commission, including the uncertainties associated with
    conducting clinical studies, and the risks and uncertainties
    associated with dependence upon the actions of regulatory agencies.
    GTC cautions investors not to place undue reliance on the
    forward-looking statements contained in this release. These statements
    speak only as of the date of this document, and GTC undertakes no
    obligation to update or revise the statements, except as may be
    required by law.
  4. [verwijderd] 28 februari 2004 12:01
    Deze daling van GTC is met name het gevolg van geruchten. Aan de ene kant bestaat er de kans dat de testgroep te klein is en dat er meer onderzoek/ informatie wordt geeist door de EMEA, wat natuurlijk weer meer tijd gaat kosten. Ook zijn er geruchten van mogelijke bijwerkingen, waardoor er ook meer onderzoek moet plaatsvinden.
5 Posts
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