Serendex Pharmaceuticals has established an exclusive agreement with CMC Biologics, Inc. focused on the development of a treatment for Diffuse Alveolar Hemorrhage, an acute bleeding in the lungs. The therapy, called Factor VIIa, is propriety to Serendex and is expected to become a breakthrough therapeutic option in this indication, as announced by the companies in a press release.
Under the agreement, Serendex Pharmaceuticals will provide access to Factor VIIa’s unique formula, while CMC Biologics will be responsible for developing, manufacturing and supplying bulk amounts of the drug for pre‑clinical and clinical studies, in addition to commercializing it on behalf of Serendex. However, Serendex will retain exclusive rights for the development and commercialization of Factor VIIa for pulmonary administration.
“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 the CEO of Serendex Pharmaceuticals, Kim Arvid Nielsen, about CMC Biologics, which is working toward offering bioprocessing solutions to pharmaceutical and biotechnology companies.
“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,” added Nielsen, as the company expects the agreement to accelerate the development of Factor VIIa in order to make it available for market approval within five years.
In addition, the Global Chief Operations Officer of CMC Biologics, Gustavo Mahler, PhD, also believes that “this strategic collaboration with Serendex is a natural fit for us and validates our technical excellence in complex protein development and manufacture. Through this agreement, Serendex and CMC Biologics will work together to address this critical patient group and bring this novel therapeutic to market quickly.”
Serendex has been dedicated to developing drugs for the treatment of respiratory conditions with acute or a chronic medical need, including pulmonary alveolar proteinosis, bronchiectasis and cystic fibrosis. The company has, therefore, been granted Orphan Drug Designation both in the United States and Europe for several of its products that are characterized by being either inhaled or induced into the lungs of the patient in order to improve patient outcomes.