Biopartners and LG Life Sciences Ltd present positive phase 3, placebo-controlled six month efficacy and safety data for sustained release recombinant human growth hormone (LB03002) given to adults with growth hormone deficiency
Baar, 11 June 2009: Biopartners GmbH and LG Life Sciences Ltd (LGLS) today presented positive phase 3, placebo-controlled six month efficacy and safety data in adults with growth hormone deficiency (GHD) for LB03002, a once-a-week, sustained release recombinant human growth hormone, at the 91st annual meeting of the Endocrine Society (ENDO 09) in Washington, DC.
Involving close to 150 adult patients with GHD in Europe and the US, the phase 3 trial demonstrated statistically significant clinical superiority of LB03002 over placebo, with a low incidence of adverse events. Compared to placebo, LB03002 demonstrated superiority in the reduction of fat mass, with positive impact on the reduction of trunk fat mass and an increase in lean body mass. LB03002 was also effective in producing notable increases in serum IGF-1 levels in adult patients with GHD.
Commenting on the new results Dr Conrad Savoy, Biopartners’ CEO said “Safety and efficacy are our paramount concerns and so we are really pleased with this important data. We are extremely optimistic about the potential of this once-a-week sustained release recombinant human growth hormone, having recently presented positive data from a three year trial in children with GHD in which LB03002 demonstrated safety and efficacy profiles comparable with existing, daily human growth hormone products. We believe the once-a-week treatment regimen will be very attractive to patients, leading to better adherence to long-term therapy, and ultimately, a more successful treatment outcome.” Biopartners, together with LG Life Sciences, is currently analyzing data from an open-label extension of this phase 3 study to evaluate long term safety and efficacy.
Biopartners is on track to submit a marketing authorization application to EMEA in 2010.
SR-rhGH (LB03002) is being co-developed by Biopartners and LG Life Sciences (LGLS). LB03002 was originally developed by LGLS using its proprietary formulation technology, who granted Biopartners a license to further develop and market it in Europe, Australia, New-Zealand and selected Asian and African countries.
For further information on Biopartners please contact:
Marie-Joëlle Gaufrès, Head of Commercial Operations
marie-joelle@Biopartners.ch
Phone: +41 (0)41 766 20 80