Vericel Says it Won’t Conduct Further Ixmyelocel-T Clinical Trials Without a Partner

Vericel’s (VCEL) shares were off 12% in early trading Thursday after the company provided an update including word that it would not pursue its license application for ixmyelocel-T for the treatment of patients with advanced heart failure unless fully funded by a partner.

Vericel said it met with the U.S. Food and Drug Administration (FDA) Sept. 29 to discuss the potential for an accelerated approval pathway for ixmyelocel-T for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy utilizing existing phase 2 clinical trial data. The FDA advised the company to conduct at least one additional clinical study to support a biologic license application, but the company said it will focus on its high-growth commercial business instead.

Verical also said MACI will be included in UnitedHealthcare’s medical policy for autolongous chondrocyte implantation in the knee. Coverage began Oct. 1. Currently, the number of covered lives for commercial plans providing access to MACI is about the same as the number that previously covered Carticel, Vericel’s first generation autologous chondrocyte implant product, the company said Thursday.

Based on the expanded medical policy coverage for MACI and the continued momentum of MACI uptake following launch, the company said it plans a further expansion of the MACI sales force in 2018.

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