Biopartners GmbH today presented three year safety and efficacy trial data in children with growth hormone deficiency (GHD) for its once–a–week, sustained release recombinant human growth hormone (SR–hGH; LB03002) at the Annual Meeting of the European Society for Paediatric Endocrinology in Istanbul.
This key phase II/III trial data – nominated for a "˜President Poster Award´ at ESPE – showed that LB03002 in children with 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 EMEA in 2009.
"We are delighted with this news, which we believe confirms our lead in this important therapeutic area where a new treatment modality has been long awaited," commented Mr Jean–Noël Treilles, CEO of Biopartners. "In the pediatric sector in particular we believe that the once–a–week growth hormone formulation will make a major difference, and will lead to children being more amenable to continued long–term therapy, and thus a more successful treatment outcome. 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"
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.
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 multi–source biopharmaceuticals. Biopartners´ mission is to develop optimized first generation biopharmaceuticals and second generation innovative formulations, such as long–acting forms that may improve patient compliance. Biopartners is developing a comprehensive range of biopharmaceutical products that may offer clinically relevant therapeutic benefits across several therapeutic areas.
