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23.12.2004 – 12:59

Baxter Healthcare SA

Baxter Announces European Union Expanded Approval of ADVATE for use in Children With Haemophilia A Less Than Six Years Old

    Zurich, Switzerland (ots/PRNewswire)

Baxter Healthcare S.A. announced today that the European Commission has  granted expanded approval of ADVATE(R) (Octocog Alfa Recombinant Coagulation  Factor VIII), for use in children with haemophilia A under six years of age.

    This expanded approval was granted on the basis of interim data from 40 of 53 paediatric patients enrolled in a Phase III clinical study. The study was conducted in 23 haemophilia treatment centers in Europe and the United States, and assessed the pharmacokinetics, safety, efficacy and immunogenicity of ADVATE in previously treated haemophilia A patients less than six years of age.

    The interim results showed an excellent/good bleed control response rate in 92.4 percent of the treatments, and a fair rating in 7.6 percent. No adverse events were deemed related to the study drug and no inhibitors were reported over a median of 74.0 exposure days. No patient has withdrawn from the study due to an adverse event.

    The safety and efficacy profile of ADVATE in children and adults are comparable, with slightly different pharmacokinetic properties in adults, but with similar bleed control response ratings, a low incidence of drug-related adverse events and low inhibitor risk in previously treated patients. These data suggest that ADVATE is efficacious and well-tolerated for the prevention and treatment of bleeding episodes in previously treated paediatric patients with haemophilia A.


    Baxter Healthcare S.A. is the principal European operating subsidiary of Baxter International Inc. Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, haemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

      Facts About ADVATE
      Advanced Category of Haemophilia A Treatment
      - ADVATE (Octocog Alfa Recombinant Coagulation Factor VIII)
      is approved in Europe and the US for the treatment of
      bleeding episodes in people with haemophilia A. In Europe,
      ADVATE is also approved for prophylaxis.
      - ADVATE is the only recombinant factor VIII that
      eliminates potential blood-borne pathogen risk by using a
      plasma/albumin-free method and combines it with the
      heritage and proven efficacy of the RECOMBINATE molecule.
      - ADVATE is the only haemophilia A therapy made without any
      added human or animal plasma proteins and albumin in the
      cell culture process, purification and final formulation.
      Based on this innovative procedure, ADVATE eliminates the
      potential risk of infections caused by pathogens that may
      be carried in these protein additives.
      Human and/or Animal Derived Plasma/Albumin Presence in
      Development Process
            Recombinant Cell      Purification  Formulation
            Therapy        Culture
            1st                 x                x
            Next                x                x                 NONE
            ADVATE          NONE          NONE              NONE
      - ADVATE was developed using the most advanced processing
      for haemophilia treatments to date. ADVATE has a similar
      full-length molecular structure to the currently
      most-prescribed treatment, RECOMBINATE, but eliminates the
      potential pathogen risk associated with the use of animal-
      and human-derived plasma protein additives.
      - ADVATE is administered directly into the bloodstream and
      works by temporarily raising the level of factor VIII in
      the blood, thus allowing the body's blood clotting process
      to function properly.
      Why Develop ADVATE?
      - The haemophilia community has requested safer
      treatment options that further reduce the potential
      risk of contracting existing or emerging infectious
      diseases that continue to be of concern with the blood
      supply[1], such as West Nile Virus and variant
      Creutzfeldt-Jakob Disease (vCJD), the human form of mad
      cow disease[2],[3].
      - The Medical and Scientific Advisory Council (MASAC)
      of the National Hemophilia Foundation has issued a
      formal recommendation (#141) advising that "all efforts
      should be made to remove human albumin from recombinant
      factor VIII products," and "increased efforts should be
      made to eliminate human and bovine proteins from the
      manufacturing process of recombinant products."[4]
      - In 2003, the United Kingdom Haemophilia Centre
      Doctors' Organisation issued a guideline stating: "To
      reduce the chance of infection by exogenous viruses in
      a recombinant concentrate, consideration should be
      given to choosing one, where available and licensed,
      that is manufactured with the least addition of human
      or animal protein." (Reference: Haemophilia. 2003;
      Demonstrated Safety Profile/Clinical Trials
      - Phase II-III clinical trials evaluated the safety,
      immunogenicity and efficacy of ADVATE in the treatment
      and prevention of bleeding in previously treated
      haemophilia A patients in a variety of clinical
      settings. Data demonstrate that ADVATE has equivalent
      pharmacokinetic properties to RECOMBINATE, the first
      non-plasma derived recombinant factor VIII therapy, and
      is effective in controlling bleeding episodes in
      patients with severe haemophilia A.
      - Side effects with the use of ADVATE are uncommon,
      with no serious adverse events related to treatment
      with ADVATE reported to date. Non-serious, moderate or
      mild adverse events related to ADVATE include: a
      strange taste, itching at the infusion site, dizziness,
      headaches, catheter-related infections, chills, hot
      flushes, diarrhea, lower limb edema, sweating, nausea,
      pain in the upper abdomen or lower chest, prolonged
      bleeding after post-operative drain removal, decreased
      red blood cell count, joint swelling and shortness of
      breath. Non-serious, but severe related adverse events
      include: fever, headache and decreased coagulation
      factor VIII levels.
      Benefits of ADVATE
      - The innovative technology used to process ADVATE
      eliminates the potential pathogen risk associated with
      the use of animal- and human-derived plasma protein
      - ADVATE is convenient for patients to use because it
      is available in extra-high potency (1500 IU/vial) so
      there may be fewer vials to reconstitute compared to
      RECOMBINATE, with a smaller infusion volume (5 mL
      solvent), which could lead to shorter infusion times
      for patients. ADVATE comes packaged with a 10mL
      syringe, butterfly, 2 alcohol swabs, 2 plasters, a
      device for reconstitution and a patient-friendly
      package insert.
      - Low rates of inhibitor development have been observed
      in previously treated patients in ADVATE clinical
      - Baxter has the capacity to ensure supplies of ADVATE
      based on current and anticipated future needs. ADVATE
      is processed by Baxter in its dedicated, state-of-the
      art, recombinant protein processing facility in
      Neuchâtel, Switzerland.

    Please see full prescribing information for further information.

    Baxter, ADVATE and RECOMBINATE are trademarks of Baxter International Inc. and its affiliates.

    [1] Kasper CK. Concentrate safety and efficacy. Haemophilia, 2002, 8, p. 161.

    [2] Update on West Nile Virus and Blood and Organ Donations, National Hemophilia Foundation, Medical Advisory #393.

    [3] Farrugia A. Evolving perspectives in product safety for haemophilia. Haemophilia (2002), 8, pp. 236-243.

    [4] MASAC Recommendation #141 Treatment of hemophilia and other bleeding disorders (revised March 2003). MASAC Treatment Recommendations, National Hemophilia Foundation, 2002

ots Originaltext: Baxter Healthcare S.A.
Im Internet recherchierbar: http://www.newsaktuell.ch

U.S. Media contact: Cindy Resman, +1(847)-948-2815, Europe Media
contacts: Hans Vanavermaete, Baxter, +32-2-650-17-03, Inge Boets,
Porter Novelli, +32-2-413-03-40,  Investor contact: Mary Kay Ladone,

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