OctoPlus signed a development and manufacturing contract with Axentis Pharma. Under terms of the deal, OctoPlus will carry out process development and clinical manufacturing of Axentis’ lead product, an inhaled liposomal formulation of tobramycin. The product, Fluidosomes™-tobramycin (also known as ARB-CF0223), is in development for the treatment of respiratory infections in cystic fibrosis patients.
Axentis started a Phase II trial with Fluidosomes™-tobramycin in September 2008. In April 2009 the product received orphan drug designation in the U.S. for the treatment of pulmonary infections caused by Pseudomonas aeruginosa. In July FDA granted the product a second orphan drug designation or the treatment of pulmonary infections caused by Burkholderia cepacia pathogens.