Clinical Phase III Trial Data Demonstrate Valtropin(R)'s Safety and Efficacy



    In a significant development for the emerging field of
    biosimilars, Biopartners' recombinant human growth hormone (rhGH) -
    Valtropin(R) - has demonstrated equivalent safety and efficacy to its
    reference product. This welcomed communication follows some concerns
    raised by established biopharmaceutical companies about the safety of
    biosimilars.

    Carried out in Europe, South Africa and the USA, the randomized,
    double-blind, comparator-controlled phase III trial assessing
    Valtropin's efficacy and safety in treatment-naive children with
    growth hormone deficiency is now published on line and will be in the
    September issue of Hormone Research.* The lead investigators and the
    lead authors, including Paul Saenger, Professor of Paediatrics at the
    Albert Einstein College of Medicine in New York concluded that "The
    one year efficacy and safety profile of Valtropin...are equivalent and
    fully comparable to the comparator rhGH".

    "Biosimilarity does not mean a compromise between cost and
    safety", said Dr Conrad Savoy, Biopartners' CSO. "Biopartners is
    committed to ensuring that its biosimilars and innovative
    biopharmaceuticals are rigorously tested for safety and efficacy,
    including appropriately designed and managed clinical phase III
    trials. The publication of this data demonstrates that Valtropin is as
    safe as the reference product which has been widely used for many
    years now. This evidence is central part of the pivotal data submitted
    to the EMEA and it laid the foundation for the European Commission
    granting the marketing authorization for Valtropin".

    In addition to Valtropin, Biopartners has an innovative sustained
    release (SR) formulation of rhGH - the only SR-rhGH in advanced Phase
    III development - aimed at a European market estimated to be worth 250
    million USD.

    * Vol. 68, No. 6, 2007

    About Biopartners Holdings AG

    Headquartered in Baar, Switzerland, with an affiliate in Germany,
    Biopartners is a global biopharmaceuticals company and a leader in the
    emerging field of biosimilars (multi-source biopharmaceuticals).
    Biopartners' mission is to develop biopharmaceuticals and innovative
    formulations of "first generation" biopharmaceuticals as well as
    advanced delivery systems that may improve patient compliance.
    Biopartners is developing a comprehensive range of biopharmaceutical
    products that may offer life-saving therapeutic benefits across many
    therapeutic areas. Biopartners has a fourth product in phase III. In
    March 2007, Biopartners was acquired by Polish biotechnology company
    Bioton S.A.