Neose Technologies Inc has announced that its partner, BioGeneriX AG, a company of the ratiopharm group, will proceed with development of GlycoPEG-GCSF under an existing collaboration agreement.
BioGeneriX also informed Neose that it has declined to exercise its option to license Neose's GlycoPEGylation technology for use with an undisclosed BioGeneriX protein. Previously on October 20, 2006, Neose amended its agreements with BioGeneriX to extend to December 31, 2006 the dates on which it could terminate the GlycoPEG-GCSF agreement, and exercise the option for the undisclosed protein.
In accordance with the amended research, co-development and Commercialisation agreement for GlycoPEG-GCSF, BioGeneriX will continue with clinical development, subject to the additional phase I and II diligence requirements added by the October 20, 2006 amendment, and will assume Neose's cost of reagent supply for clinical development as of January 1, 2007.
Neose retains the marketing rights to GlycoPEG-GCSF in the United States, Canada, Mexico and Japan. GlycoPEG-CGSF is currently in phase I clinical trials in a Western European jurisdiction.
BioGeneriX declined to exercise its option to an exclusive, worldwide license to Neose's GlycoPEGylation technology for use with a GlycoPEGylated erythropoietin made in Chinese hamster ovary (CHO) cells (GlycoPEG-CHO-EPO).
The identity of this protein was previously undisclosed in accordance with the terms of the amended Research, License and Option agreement. All rights to Neose's GlycoPEGylation technology as it applies to GlycoPEG-CHO-EPO revert to Neose.
"We are pleased that BioGeneriX has decided to proceed with GlycoPEG-GCSF," said George J Vergis, PhD, Neose's president and CEO. "This product candidate is in phase I and represents a significant investment by BioGeneriX and Neose. Neose's rights to GlycoPEG-GCSF will continue to increase in value as BioGeneriX advances the product candidate toward commercialisation in its territory, with no further cost to Neose."
"When we began our collaboration with BioGeneriX on GlycoPEG-CHO-EPO, our NE-180 (GlycoPEGylated EPO expressed in insect cells) was still in preclinical development. We viewed GlycoPEG-CHO-EPO as an alternative opportunity to target the multi-billion dollar EPO market with all development funded by our partner. Although the decision by BioGeneriX to cease further development was unrelated to the early development results from the programme, in view of the clinical progress we have made with NE-180, we will concentrate our investment on further clinical development of NE-180 as a next-generation EPO competitive with best-in-class EPO drugs currently on the market and in development," continued Vergis.
G-CSF is prescribed to stimulate the production of neutrophils, and is approved for sale in major markets around the world for the treatment of neutropenia associated with myelosuppressive chemotherapy.