PharmaMar and Chugai link up to commercialize Aplidin in Europe

Spanish drugmaker Zeltia (ZEL: MC), through its biotech subsidiary PharmaMar, and Japan’s Chugai Pharmaceutical (TYO: 4519) have entered into a license agreement where Chugai Pharma Marketing would promote PharmaMar’s Aplidin (plitidepsin) for the treatment of multiple myeloma (MM) in eight European countries (France, Germany, the UK, Belgium, the Netherlands, Luxemburg, Ireland and Austria).

Under the terms of the accord, PharmaMar receives an upfront payment of 5 million euros ($6.8 million) and will be eligible for more than 30 million euros related to the regulatory, development and sales milestones. PharmaMar will retain exclusive production rights and will sell the product for commercial use to Chugai, which is majority owned by Swiss pharma major Roche (ROG: SIX).

Ph III trial in relapsed and refractory MM ongoing

The Phase III trial (ADMYRE) for the treatment of relapsed and refractory MM is currently ongoing. Aplidin showed a favorable safety profile and efficacy in combination with dexamethasone vs. dexamethasone alone in the Phase II trial. Submission of a marketing authorization application (MAA) in Europe is expected in fourth-quarter 2015. The dossier for European Union approval will also be valid for more than 40 countries outside the EU and PharmaMar is looking into opportunities to license the compound in those territories. Aplidin has orphan designation for multiple myeloma in Europe and the USA.