22nd September, 2016 – TTY Biopharm (as PharmaMar’s exclusive distribution agent) and PharmaMar jointly announced today the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Aplidin® (plitidepsin), a new chemical entity. The Phase III “ADMYRE” clinical trial has met its primary endpoint where demonstrated Aplidin® (plitidepsin)’s efficacy and safety. In ADMYRE study, the result of Aplidin® with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM) who had been evaluated with 3-6 prior therapeutic regimens has shown a statistically significant 35% reduction in the risk of progression or death than the controlled arm.
The submission of MMA to the EMA determines a crucial milestone for TTY Biopharm and PharmaMar. Both TTY Biopharm and ParmaMar have thorough plans for Aplidin® (plitidepsin)’s preparation. PharmaMar has achieved an earlier submission of MMA. Sequentially, TTY Biopharm plans to present a registration dossier to TFDA in the 4th quarter of 2016.
About Aplidin® (plitidepsin)
Plitidepsin is an investigational novel anticancer agent of marine origin, obtained from Aplidium albicans, of the genus ascidia. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apoptosis (programed death). In “ABMYRE” study, patients were successfully recruited and its results show a statistically significant 35% reduction in the risk of progression or death than the controlled arm. We believe Aplidin® could become a therapeutic alternative for patients with multiple myeloma.
According to Taiwan Cancer Registry, 527 new cases were diagnosed in 2012. Around 75% patients received chemical and steroid treatments and most of them accepted more than one treatment. Based on Cancer Statics’s report in 2015, relapsed/refractory MM is a type of blood cancer which represents 10% of all hematological malignancies.