The therapeutic focus will be on acute bleeding in the lungs (Diffuse Alveolar Hemorrhage) and if successful Serendex Pharmaceuticals might be able to offer breakthrough therapy in this indication.
CMC Biologics, which provides bioprocessing solutions to pharmaceutical and biotechnology companies, will develop, manufacture and supply Factor VIIa bulk drug substance for acute pulmonary administration for pre-clinical and clinical studies as well as for commercialization on behalf of Serendex Pharmaceuticals.
"The agreement with CMC Biologics is key to the next phase of our development of Factor VIIa, as they have a demonstrated track record as one of the most successful, independent biologics contract manufacturers in the world." said Kim Arvid Nielsen, CEO, Serendex Pharmaceuticals.
"We see a high unmet need within acute bleeding in the lungs as well as a high level of documentation on patient cases covering the use of Factor VIIa for this indication, so we look forward to explore and realize the full potential of Factor VIIa in collaboration with CMC Biologics."
"This strategic collaboration with Serendex is a natural fit for us and validates our technical excellence in complex protein development and manufacture," said Gustavo Mahler, PhD, Global Chief Operations Officer of CMC Biologics.
"Through this agreement, Serendex and CMC Biologics will work together to address this critical patient group and bring this novel therapeutic to market quickly."
The contract is a great leap forward for Serendex Pharmaceuticals, which could lead to a market approval for FVIIa within five years.