AMSTERDAM, July 29, 2010 /PRNewswire/ -- 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."
About SynCo Bio Partners B.V.
SynCo Bio Partners is a GMP-licensed bulk drug substance and final product CMO with clinical and commercial production experience with microbial and mammalian systems. This experience has been acquired by developing new production processes for a number of international clients and producing a wide variety of different vaccines, live biotherapeutics and recombinant proteins in our state-of-the-art, GMP-licensed facilities since inception in 2000.
Focused solely on biopharmaceuticals, SynCo Bio Partners acts as a strategic, long-term partner delivering product on time to the highest quality standards. SynCo's team is committed to exceeding customer expectations by taking a truly collaborative approach to manufacturing. For more information, please visit http://www.syncobiopartners.com.
Versartis, Inc. is a biotechnology company developing therapeutics for the treatment of metabolic diseases and endocrine disorders. The company's lead product candidates are VRS-859, a once monthly form of the GLP-1 analog, exenatide and VRS-317, a once monthly form of human growth hormone. Versartis is pursuing the development of new therapeutic proteins utilizing the Amunix Inc. novel half-life extension XTEN technology.
Versartis, a joint venture company between Amunix, Inc. and Index Ventures, owns and develops the novel drug candidates in metabolic diseases and endocrinology that it has licensed from Amunix. Versartis has established preclinical proof-of-concept for three product candidates in its pipeline: exenatide and IL-1ra for diabetes, and hGH for growth hormone deficiency. Further information on Versartis can be found at http://www.versartis.com.
SOURCE SynCo Bio Partners B.V.