This key Phase II/III trial data showed that LB03002 in children with growth hormone deficiency (GHD) demonstrates safety and efficacy profiles comparable with existing, daily human growth hormone products.
Biopartners is also well advanced in its pivotal Phase III sustained release recombinant human growth hormone trials in children and adults with GHD and is on track to submit a marketing authorization application to the European Medicines Agency (EMEA) in 2009.
SR-rhGH (LB03002) is being co-developed by Biopartners and LG Life Sciences (LGLS). LB03002 was originally developed by LGLS, which granted Biopartners a license to further develop and market it in Europe, Australia, New-Zealand and selected Asian and African countries. The formulation is patent protected and the patent is owned by LGLS.
Jean-Noel Treilles, CEO of Biopartners, said: “With this three-year study we have set another important milestone on our way to enabling a regulatory submission to EMEA in 2009, confident that the safety and efficacy profile of the sustained release formulation will be conducive.”