Company plans to file for approval in the U.S. and EU by the middle of next year.
ThromboGenics signed a 10-year supply agreement with MSD Biologics, 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.
Microplasmin, which is ThromboGenics’ lead drug candidate, recently completed two successful Phase III trials in patients with vitreomacular adhesion (VMA). ThromboGenics is targeting for BLA and MAA submissions by mid 2011.
MSD Biologics, a contract manufacturing organization with specific expertise in microbial-derived biologics, has been producing microplasmin for ThromboGenics since 2007. It provided the clinical bulk substance for ThromboGenics’ Phase III program, which recruited over 650 patients in the U.S. and Europe.
MSD Biologics will produce microplasmin at its Billingham, U.K., facility, which has been approved for commercial production by both the FDA and the EMEA. Microplasmin is a truncated form of the natural human protein plasmin. ThromboGenics has reportedly created the first stabilized and readily manufactured form of this molecule.