PharmaMar, a leading biopharmaceutical company, has announced the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM). This is a type of blood cancer which represents 10% of all haematological malignancies.
PharmaMar has gone through with this application given the positive da ta obtained from the randomized, phase III ADMYRE clinical trial, where the efficacy and safety of Aplidin with dexamethasone versus dexamethasone alone in patients with relapsed/refractory MM after at least three , but no more than six, prior therapeutic regimens has been evaluated. The results of the ADMYRE study showed a statistically significant 35% reduction in the risk of progression or death over the comparator. The study met its primary endpoint.
The submission of this MMA to the EMA represents an important milestone for PharmaMar. “We have achieved positive results with this molecule throughout its clinical development and we believe Aplidin could become a novel therapeutic alternative for patients with multip le myeloma,” says Luis Mora, managing director of PharmaMar ´s Oncology Business Unit, who also adds “that we estimate the answer from the regulatory agency for the second half of 2017.”
Aplidin has received orphan drug designation by the European Commission and the US Food and Drug Administration (FDA). Up to today, PharmaMar has various licensing agreements for the sales and distribution of this compound with Specialised Therapeutics Asia PTE Ltd. (Singapore) in several countries for Southeast Asia, Australia and New Zealand; with TTY Biopharm in Taiwan ; and with Chugai Pharma Europe Ltd . in 8 European countries.
PharmaMar will be paid by Chugai Pharma Europe Ltd. 4 million euros for the presentation of the above mentioned MAA.
Plitidepsin is an investigational anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans . It specifically binds to the eEF1A2 and targets the non - canonical role of this protein, resulting in tumour cell death via apoptosis (programed death). Plitidepsin is currently in clinical development for haematological cancers, including a phase Ib trial in relapsed or refractory multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone, and a phase II study in relapsed or refractory angioimmunoblastic T - cell lymphoma. Plitidepsin has received orphan drug designation in the European Union and the United States of America.