Jul 30 2010
SynCo Bio Partners today announced an extension of its successful collaboration with Versartis, Inc. following the recent initiation of a Phase 1 clinical trial in type 2 diabetes mellitus (T2DM) patients with monthly dosing of VRS-859. This news comes less than 12 months since the parties entered into a strategic partnership to manufacture Versartis' lead product VRS-859 (exenatide-XTEN).
Under the extended agreement, SynCo will scale-up a second manufacturing process on behalf of Versartis, this time in preparation for the GMP manufacture of VRS-317, a once monthly form of human growth hormone for the treatment of children and adults with growth hormone deficiency. As with the VRS-859 program, SynCo will also provide fill and finish services for the manufacture, testing and release of formulated Drug Product vials. SynCo completed process development and optimization, scale-up and GMP manufacture of VRS-859 for Phase 1 clinical studies earlier this year.
"Versartis achieved its first major clinical milestone, a Phase 1 trial of VRS-859, in just over one year after Series A demonstrating our ability to efficiently and quickly execute our development plans," said Jeffrey L. Cleland, Ph.D., Versartis' Chief Executive Officer. "The strength and commitment of our collaborators, such as SynCo Bio Partners, is a key factor in this achievement and we look forward to a similarly successful partnership for our second product, VRS-317."
Pierre Warffemius, SynCo Bio Partners Chief Executive Officer stated, "SynCo is extremely proud of its success in supporting Versartis to progress its pipeline. The VRS-859 manufacturing program was completed on time due to the combined expertise and management of the Versartis-SynCo project team. As world leaders in advancing biopharmaceuticals from bench to market, we very much look forward to helping Versartis also meet their corporate objectives for VRS-317."