Eutropin Plus (somatropin SR) / LG Chem, Bioton - LARVOL DELTA

Eutropin Plus / Declage (somatropin SR, Valtropin SR, SR-rhGH, sustained release-human growth hormone, LB 03002, LB03002, BPLG-003) / LG Life Sciences & Biopartners (Bioton) - LG Life Sciences has developed sustained-release formulation of Valtropin, which has been licensed to BioPartners (now Bioton) & is expected to be submitted for EU approval

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Efficacy of short-term growth hormone treatment in prepubertal children with idiopathic short stature (Yonsei Med J) - P=NA, N=36; “This 26-week GH treatment was effective in increasing serum levels of insulin-like growth factor (IGF)-I and IGF binding protein (IGFBP)-3 from baseline (p<0.0001). Eutropin was well tolerated and there were no withdrawals due to adverse events. No clinically significant changes in laboratory values were observed.”

Clinical data • Growth Hormone

LG Life Sciences Ltd (LGLS) present positive phase 3, twenty-four months efficacy and safety data for sustained release recombinant human growth hormone (LB03002) given to children with growth hormone deficiency (LG Life Sciences) - P3, N=167; Biopartners presented positive P3 results of 24 month efficacy & safety in children with GHD for LB03002, a once-a-week, sustained release recombinant human growth hormone; These positive data further confirm previously presented positive data in children with GHD from a two year comparative trial versus daily growth hormone which was followed by a one year extension; An extension of this pediatric P3 study is currently ongoing in India & Egypt

P3 data • Growth Hormone

Efficacy and safety of sustained-release recombinant human growth hormone in korean adults with growth hormone deficiency (Yonsei Med J) - P4, N=132; NCT01605331; Sponsor: LG Life Sciences; "The IGF-1 level of 108.67±74.03 ng/mL was increased to 129.01±68.37 ng/mL (p=0.0111) and the AGHDA QoL score was decreased from 9.80±6.51 to 7.55±5.76 (p<0.0001) at week 12 compared with those at baseline. Adverse events included pain, swelling, erythema, and warmth sensation at the administration site, but many adverse events gradually disappeared during the investigation."

P4 data • Growth Hormone

Metabolic effects of LB03002, a sustained release formulation of rhGH, in children with GH Deficiency (ESPE 2012) - Presentation time: Saturday, Sept 22, 2012, 13:00 - 14:00; P3, N=167; Data show that weekly treatment with LB03002 has a comparable metabolic effect as treatment with daily rhGH; Changes from baseline of assessed parameters were not clinically relevant

P3 data • Growth Hormone

Three-year efficacy and safety of LB03002, a once-weekly sustained-release growth hormone (GH) preparation, in prepubertal children with GH Deficiency (GHD) (J Clin Endocrinol Metab) - P3, N=51; LB03002 at doses of 0.5 mg/kg/wk & 0.7 mg/kg/wk was shown to be effective & safe with once-weekly dosing in GH-deficient children, & 0.5 mg/kg/wk LB03002 was chosen as the optimal dose for long-term assessment

P3 data • Growth Hormone