Decision was made due to delays with the FDA related to firm’s medical technology for chronic heart failure and low anticipated sales in Europe.
Vasogen is restructuring its resources in light of the stalled development of Celacade, its medical technology for treating of chronic heart failure. The firm plans to put a hold on the planned confirmatory study and cut 85% of its workforce.
Vasogen will incur cash expenditures of approximately $2.6 million in the second quarter. The company believes that this strategy will allow it to focus its resources on its neuro-inflammatory compounds, still in preclinical and early development.
While Celacade received EU approval, the product has come under scrutiny at the FDA, which requested that another clinical study be performed. Considering these delays, the uncertainty surrounding the FDA’s continued opposition to a relatively small trial utilizing a Bayesian statistical design, and lack of capital, Vasogen has suspended funding the trial.
Additionally, Vasogen’s European partner, Grupo Ferrer, has forecast lower than anticipated revenues on Celacade. Vasogen has hence decided to discontinue operational and financial support for European commercialization.
The company reports that it will continue to work with the FDA to finalize the design of the study and will evaluate funding alternatives for the U.S. clinical investigation as well as options with Ferrer for the European market.
Vasogen will concentrate on its VP series of drug candidates. VP025, the lead compound from this class of therapeutics, has completed a Phase I trial.
“We have developed significant expertise and intellectual property in the area of immune-system modulation to treat inflammatory disorders, with data acquired from numerous preclinical models of human disease,” comments Anthony Bolton, Ph.D., CSO of Vasogen. “We are impressed with their ability to reduce markers of inflammation and improve outcome measures across a number of experimental models.”