Biopartners' growth hormone, 3-year data
Barr, Switzerland-headquartered Biopartners GmbH presented three-year safety and efficacy trial data for its once-a-week, sustained-release recombinant human growth hormone LB03002 in children with growth hormone deficiency at the annual meeting of the European Society for Pediatric Endocrinology in Istanbul, Turkey.
The Phase II/III data demonstrated safety and efficacy profiles comparable with existing products. Biopartners says it 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.
The drug is being co-developed by Biopartners and LG Life Sciences. LGLS originally licensed the product to Biopartners for further development and marketing in Europe, Australia, New Zealand and selected Asian and African countries.
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