PR Newswire
MADRID, September 22, 2016
MADRID, September 22, 2016 /PRNewswire/ --
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.
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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.
Paula Fernández
Media Relations: +34-638-79-62-15
Investor Relations: +34-914444500
SOURCE PharmaMar
