MAA submission of this once-weekly therapy is scheduled for 2010.
Biopartners and LG Life Sciences reported encouraging results from a Phase III trial of their sustained-release, once-weekly recombinant growth hormone, LB03002. Biopartners said it remains on track to submit an MAA for the drug to the EMEA in 2010.
The six-month, placebo-controlled trial with LB03002 included approximately 150 adult patients with growth hormone deficiency (GHD). Results showed the new drug was significantly better than placebo in terms of fat mass reduction with patients demonstrating reductions in trunk fat mass and increases in lean body mass. Treatment with LB03002 also led to significant increases in serum IGF-1 levels.
“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,” comments Conrad Savoy, Ph.D., Biopartners’ CEO. “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 outcomes.”
Biopartners and LGLS are also evaluating safety and efficacy data from an open-label extension of the Phase III trial.
LB03002 was originally developed by LGLS using its formulation technology. Biopartners has a license to develop and market the drug in Europe, Australia, New Zealand, and selected Asian and African countries. Headquartered in Baar, Switzerland, Biopartners is owned by Polish biotechnology company Bioton. Based in Seoul, LGLS was spun out of LG Chemicals in 2002.
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