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ThromboGenics signs deal with MSD Biologics

10-year supply agreement for the production of microplasmin keeps 2011 FDA and EMA submission goals for prospective retinal disorder treatment on track

Brussels-based biopharmaceutical company, ThromboGenics, announced that it has signed a 10-year supply agreement with contract manufacturing organisation MSD Biologics (UK), 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). The results of these trials demonstrated microplasmin's potential to treat retinal disorders. ThromboGenics is targeting Biologic License Application (BLA) submission to the US Food and Drug Administration (FDA) and marketing authorisation application (MAA) to the European Medicines Agency (EMA) by mid 2011.

MSD Biologics has been producing microplasmin for ThromboGenics since 2007, and provided the clinical bulk substance for ThromboGenics' extensive phase III programme that recruited over 650 patients in the US and Europe. MSD Biologics will product microplasmin at its Billingham facility in the UK.

According to Dr Patrik De Haes, CEO of ThromboGenics: "The signing of this 10-year supply agreement with MSD Biologics is a further important step in our preparations to commercialise microplasmin."

He stated that with this deal in place, the company remains on track to file microplasmin with both the FDA and EMA by mid 2011 to gain marketing approval for this potential new treatment option for a broad range of retinal disorders.

30th September 2010

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