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BioPartners

Developing Biologics, Delivering Patient Care

More info about BioPartners

Innovative Biopharmaceuticals

BioPartners

Biopartners' aim is to be a leader in developing and commercializing biopharmaceuticals for which there are substantial unmet patients/medical needs. This strategy involves bringing to market both innovative formulations and/or novel delivery systems of first-generation biopharmaceuticals.

Once-a-week prolonged release recombinant human growth hormone

Status: Late Phase III clinical development.

Human growth hormone (hGH) is secreted by a specialised structure in the brain, the pituitary; it not only induces growth, but also regulates important metabolic effects.

Recombinant human growth hormone (rhGH) therapies have been successfully used to treat growth hormone deficiencies for 20 years. All current formulations require daily administration by subcutaneous injection, administered at home by the patient or parent. Although therapy is in general highly successful, the daily regimen and dislike of injections leads in some cases to non-compliance and therefore ineffective therapy at great cost to the healthcare provider.

To counter this and to realise an unmet clinical need, Biopartners is developing a once-a-week prolonged release formulation of recombinant human growth hormone (rhGH). Over a typical five year treatment period, Biopartners’ once-a-week prolonged release rhGH would save over 1500 injections compared to standard daily therapy. Since most patients are young children and therefore particularly concerned about injections, this innovative product would be a major breakthrough in Growth Hormone therapy, providing greater convenience, acceptability and improved compliance compared with daily hGH preparations.

To Biopartners’ knowledge, its once-a-week prolonged release rhGH is the only such product in well advanced Phase III clinical trials and it is on track to be the first to reach the market. Based on Biopartners’ extensive experience of handling biopharmaceuticals and rhGH through the complex regulatory approval pathways, a submission for market authorisation to the EMA is targeted for 2010.

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