PharmaMar submits Aplidin MAA

PharmaMar S.A. (Madrid:PHM) submitted an MAA to EMA for Aplidin plitidepsin in combination with dexamethasone to treat relapsed or refractory multiple myeloma (MM). In March, the company said the candidate significantly improved progression-free survival (PFS) in the Phase III ADMYRE study to treat MM, meeting the trial's primary endpoint (see BioCentury Extra, March 31).

Aplidin is a marine-derived VEGF inhibitor. In 2014, PharmaMar granted Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) rights to the candidate in eight EU countries, including the U.K. The MAA submission triggers a EUR 4 million ($4.5 million) payment to PharmaMar from Chugai. ...