LEUVEN, Belgium, September 30, 2010 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), 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 U.S. and Europe. MSD Biologics will produce microplasmin at its Billingham facility (UK), which has been approved for commercial production by the U.S. 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 is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company's lead product microplasmin has completed two Phase III clinical trials for the non-surgical treatment of retinal disorders. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long acting anti-coagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
About Merck BioManufacturing Network
Merck BioManufacturing Network (known outside the USA and Canada as MSD BioManufacturing Network) is a full service CMO providing development and manufacturing services for biologics to pharmaceutical and biotechnology companies. It comprises the operations at Billingham, UK (formerly Avecia Biologics), and at Research Triangle Park, NC, USA (formerly Diosynth Biotechnology). Merck is known as MSD outside USA and Canada. For additional information about Merck BioManufacturing Network, please visit http://www.biomanufacturingnetwork.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
For further information please contact: ThromboGenics Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 [email protected] Stuart Laermer, Chief Business Officer Tel: +1-(212)-201-0920 [email protected] Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44-(0)207-638-95-71 [email protected] Merck BioManufacturing Network Bridget Hall, MSD Biologics (UK) Ltd Tel : +44-(0)1642-367320 [email protected]
SOURCE ThromboGenics NV