ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that it has signed a 10-year supply agreement with MSD Biologics (UK) Ltd, part of the Merck BioManufacturing Network, for the production of microplasmin.
ThromboGenics anticipates that this deal will meet its long-term commercial needs for bulk drug substance of this novel therapeutic agent.
Microplasmin, which is ThromboGenics’ lead drug candidate, recently completed two successful Phase III clinical trials in patients with vitreomacular adhesion (VMA). These Phase III results demonstrated microplasmin’s potential to transform the treatment of retinal disorders. ThromboGenics is targeting BLA submission to FDA and MAA to EMA by mid 2011.
MSD Biologics, a contract manufacturing organization with specific expertise in microbial-derived biologics, has been producing microplasmin for ThromboGenics since 2007, and provided the clinical bulk substance for ThromboGenics’ extensive Phase III program that recruited over 650 patients in the US and Europe. MSD Biologics will produce microplasmin at its Billingham facility (UK), which has been approved for commercial production by the US FDA and the EMA.
Microplasmin is a truncated form of the natural human protein plasmin. ThromboGenics has created, on a proprietary basis, the first stabilized and readily manufactured form of this molecule.
Dr. Patrik De Haes, CEO of ThromboGenics, commented, “The signing of this 10-year supply agreement with MSD Biologics is a further important step in our preparations to commercialize microplasmin. I am glad that we will be continuing to work with the organization and team that have done such a good job in providing us with the bulk microplasmin that we have used for our successful Phase III program. With this deal in place, we remain on track to file microplasmin with both the FDA and EMA by mid 2011 to gain marketing approval for this exciting potential new treatment option for a broad range of retinal disorders.”
Steve Bagshaw, Site General Manager, MSD Biologics, added, “We are delighted that ThromboGenics has chosen to continue to work with MSD through this long term supply agreement for the production of microplasmin. We look forward to extending our successful working relationship with them as they progress through the next stage of commercialization plans.”
ThromboGenics
