As a result of this termination, Replidyne will re-acquire the rights for the antibiotic previously granted to Forest.
The FDA has issued a non-approvable letter for faropenem for four adult indications: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections.
“Though the regulatory requirements for the approval of antibiotics have changed, we believe that faropenem can meet these new standards and are we working closely with the FDA to define a regulatory pathway for faropenem approval,” stated Kenneth Collins, Replidyne's president and CEO.
In the non-approvable letter, the FDA recommended further clinical studies for all indications.
However Replidyne commented that the FDA did not raise any safety concerns or chemistry, manufacturing or controls issues related to the product.
Replidyne previously stopped a study of the drug comparing it to Sanofi-Aventis's Ketek because the FDA claimed the risks of the comparison drug outweighed the benefits. Ketek has been linked to reports of severe liver problems.
Forest said it had terminated the agreement because the non-approvable letter had raised regulatory uncertainty.