Teva terminates oral Copaxone program
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Teva is discontinuing development of an oral formulation of its multiple sclerosis therapy Copaxone (glatiramer) due to disappointing results in two pilot Phase II studies, the firm says in a March 20 filing with the Securities & Exchange Commission. The firm also had a Phase III CORAL study looking at 5 mg and 50 mg doses of oral Copaxone, but that trial also failed to produce statistically significant results. Teva "is considering future development of Copaxone in various non-parenteral formulations and will make its decision in the context of its entire MS portfolio," the firm says. Teva has rights to Ivax/Serono's Phase III oral MS agent Mylinax (cladribine) by way of its recent acquisition of Ivax...