Symphogen and Biovitrum Initiate Phase 1 Clinical Trial with The First Recombinant Polyclonal Antibody to Enter Clinical Evaluation



    Symphogen and Biovitrum today announced the initiation of a Phase
    1 clinical trial to test the safety, pharmacokinetics and
    pharmacodynamics of Sym001 (Anti-RhD) in healthy volunteers. Sym001 is
    a recombinant, polyclonal antibody product candidate, comprised of 25
    different anti-Rhesus D antibodies. Sym001 is in development for the
    treatment of Idiopathic Thrombocytopenic Purpura (ITP) and for the
    prevention of Hemolytic Disease of the Newborn (HDN). Symphogen and
    Biovitrum are jointly developing Sym001 under a co-development and
    commercialization agreement announced in February 2006.

    "Sym001 is the first ever recombinant polyclonal antibody to enter
    human clinical trials. The approval from the FDA to enter Phase 1 and
    the dosing of our first subjects are very significant milestones for
    Symphogen, and they serve as a demonstration of our successful
    partnership with Biovitrum," said Kirsten Drejer, Ph.D., CEO of
    Symphogen. "This landmark achievement for us is a clear validation
    that our platform technologies are able to generate consistent batches
    of important products which can progress now into clinical
    evaluation."

    Mats Pettersson, CEO of Biovitrum, said, "We are very happy that
    we now have six projects in the clinic. We are gearing up for an
    intense year with a very strong news flow from our pipeline both in
    terms of results from ongoing trials and initiation of new trials
    especially within our protein-based specialist programs. Our
    partnership with Symphogen is of great strategic value and fits well
    with Biovitrum's long experience and broad knowledge within the area
    of protein therapeutics. Symphogen's technology platform with
    a recombinant polyclonal antibody product enables us to focus on
    diseases currently treated by traditionally produced immunoglobulins.
    This new approach has a broader therapeutic potential and the concept
    is well showcased in our partnership."

    About the Sym001 Phase 1 Trial

    Up to 39 RhD positive and 18 RhD negative healthy volunteers will
    be enrolled in the double-blind, randomized, placebo-controlled, dose
    escalation Phase 1 trial. The primary study objective is to assess the
    safety and tolerability of Sym001 following a single intravenous
    infusion. Secondary trial objectives are to evaluate the
    pharmacokinetic profile (binding, distribution, excretion), the
    pharmacodynamic profile (clinical activity) and any potential
    immunogenicity (immune system reaction) of Sym001. The trial is being
    conducted at a clinic in the United States and the study is expected
    to be completed with results at the end of 2007.

    To the Editor:

    About the Market

    Conventional immunoglobulin products are isolated from the blood
    of donors, and therefore subject to potential safety issues due to the
    risk of disease transmission, as well as to supply shortages caused by
    dependence on donor blood availability. Symphogen and Biovitrum's
    recombinant polyclonal antibodies can be produced in unlimited supply,
    and they carry decreased risk of viral or prion transmission,
    qualities that the Companies believe make them a more attractive
    therapeutic option for both ITP and prophylaxis of HDN.

    Symphogen's technology can also address the large markets
    currently targeted by monoclonal antibody therapies, and Symphogen's
    preclinical pipeline includes products targeting infectious diseases
    and cancer.

    About Sym001

    Sym001 consists of 25 different recombinant polyclonal anti-Rhesus
    D antibodies for the treatment of Idiopathic Thrombocytopenic Purpura
    and for the prevention of Hemolytic Disease of the Newborn.
    Preclinical studies of Sym001 demonstrated its binding potency and
    biological function similar to existing plasma-derived anti-RhD
    products. Symphogen has a co-development and commercialization
    agreement with Biovitrum AB for Sym001.

    Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding
    disorder characterized by abnormally low platelet levels, making it
    difficult for the blood to clot normally. Hemolytic Disease of the
    Newborn may result when a RhD-negative woman becomes sensitized to RhD
    while carrying a RhD-positive child. This immune reaction can trigger
    a maternal antibody response in subsequent RhD-positive pregnancies,
    causing the breakdown of fetal red blood cells.

    About Biovitrum

    Biovitrum is one of the largest biopharma companies in Europe.
    With operations in Sweden and in the UK Biovitrum conducts research
    and develops pharmaceuticals for unmet medical needs both for common
    diseases and conditions that affect smaller patient populations.
    Biovitrum has a broad and balanced R&D portfolio with several projects
    in clinical and preclinical phases for the treatment of obesity,
    diabetes, inflammation and eye and blood diseases as well as a number
    of well defined niche indications. Biovitrum develops and produces
    protein-based drugs on a contractual basis and markets a range of
    specialist pharmaceuticals primarily in the Nordic countries.
    Biovitrum has revenues of approximately SEK 1.2 billion and 550
    employees. Biovitrum is listed on the Stockholm Stock Exchange since
    September 15, 2006. For more information see www.biovitrum.com.

    About Symphogen

    Symphogen is the leader in developing recombinant polyclonal
    antibodies (pAb), a new class of biopharmaceuticals for the treatment
    of serious human diseases. By employing its pioneering antibody
    discovery and manufacturing technologies, Symphogen generates
    recombinant antibody compositions that capture the diversity and
    effectiveness of the natural immune system. Symphogen is building a
    proprietary product pipeline within several disease areas, including
    infectious diseases and cancer. Symphogen has established
    collaborations with international pharmaceutical companies.

    Symphogen is a private biopharmaceutical company with over 75
    employees, based in Copenhagen, Denmark. Refer to www.symphogen.com
    for further information on Symphogen.