Madrid, Spain (Press Release) – PharmaMar (MSE:PHM) has announced today 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 hema­to­logical malig­nan­cies.

PharmaMar has gone through with this appli­ca­tion given the positive data 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 multiple 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.

About APLIDIN® (plitidepsin)

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 tumor cell death via apop­tosis (programed death). Plitidepsin is cur­rently in clin­i­cal devel­op­ment for hema­to­logical 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.

Source: PharmaMar.