Laureate Pharma given new antibody contract
protein production company, has been given a new contract by
Bradmer Pharmaceuticals to develop and manufacture its novel brain
cancer treatment for Phase III clinical studies planned in the US
in late 2006.
The terms of the agreement were not disclosed, however, Laureate Pharma has already initiated the project and expects to complete the manufacturing of Neuradiab before the end of the year.
Neuradiab is a monoclonal antibody, used to treat glioblastoma multiforme (GBM), the most common and deadly form of brain cancer in the world.
US-based Laureate is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products.
Mammalian cells are grown in stirred-tank or hollow-fibre bioreactors for production of biopharmaceutical proteins, which are purified by Laureate's semi-automated chromatography systems.
"This manufacturing contract, incorporating Laureate Pharma's unique expertise and experience, is an important step in our plans towards initiating a multi-center clinical trial over the next year," said Mark Rogers, CEO of Bradmer.
To date, Neuradiab has been studied in over 160 patients with promising results and has completed a Phase II clinical trial conducted by researchers at Duke University.
The treatment was recently granted Orphan Drug Status by the US Food and Drug Administration, providing eligibility for a special seven-year period of market exclusivity upon marketing approval, potential tax credits and grant funding for research and development, the possibility of reduced filing fees for marketing applications and, particularly, assistance with the review of clinical trial protocols.
