PharmaMar intends to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year

Madrid (Press Release) – PharmaMar (MSE:PHM) today announced positive top-line results of its Phase III clin­i­cal trial -ADMYRE- with Aplidin® (plitidepsin) in combination with dexa­metha­sone versus dexa­metha­sone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin® has shown a statistically sig­nif­i­cant 35% reduction in the risk of pro­gres­sion or death over the com­parator (p=0.0054). The study has met its pri­mary end­point.

This pivotal, ran­dom­ized, open-label, inter­na­tional, multi­center Phase III clin­i­cal trial, called ADMYRE, en­rolled 255 patients in 83 medical centers across 19 countries (including the U.S, Europe and Asia-Pacific) with re­lapsed or re­lapsed and refractory multiple myeloma after at least three but no more than six prior thera­peutic regi­mens.

The efficacy of plitidepsin in com­bi­na­tion with dexa­metha­sone versus dexa­metha­sone alone has been eval­u­ated by means of PFS calculated using the IMWG (International Myeloma Work­ing Group) criteria and other sec­ond­ary efficacy endpoints. A full description of the final ADMYRE data will be submitted for pre­sen­ta­tion at an up­coming medical meeting.

“Taking into account these positive results, we intend to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year”, said Luis Mora, Managing Director of the Oncology Business Unit of PharmaMar, who added "I´d like to thank all the patients, physicians and the dedicated team at PharmaMar who helped par­tic­i­pate in the success of this trial. Aplidin® may be our second drug of marine origin in the market”.

As pre­vi­ously disclosed PharmaMar has entered into licensing agree­ments to market and distribute the drug can­di­date Aplidin® with Specialised Therapeutics Asia, covering several Asian countries, Australia and New Zealand; with TTY Biopharm in Taiwan; and with a co-promotion agree­ment in 8 European countries with Chugai Pharma Europe.

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hema­to­logical malig­nan­cies, that is caused by malignant plasma cells that very rapidly multiplyⁱ. Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produces the anti­bodies nec­es­sary to fight in­fec­tionsⁱⁱ. Abnormal cells produce a type of anti­body that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to estab­lish­ed disease. In 2015, 26,850 new cases were diagnosed in the US, and about 11,200 people died of this diseaseⁱⁱⁱ.In Europe, the incidence is 4.5–6.0 out of 100 000 diag­nosed per year^iv.

About APLIDIN® (plitidepsin)

Plitidepsin is an inves­ti­ga­tional anticancer agent of marine origin, originally obtained from the ascidian Aplidium albicans. It is a first-in-class drug specifically targeting eEF1A2 in tumor cells. Plitidepsin is cur­rently in clin­i­cal devel­op­ment for hema­to­logical cancers, in­­clud­ing this Phase III study in re­lapsed or refractory multiple myeloma, 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 by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading bio­pharma­ceu­tical com­pany in the discovery and devel­op­ment of inno­va­tive marine-derived anticancer drugs. The com­pany has an important pipe­line of drug can­di­dates and a robust R&D on­col­ogy pro­gram. PharmaMar develops and com­mer­cial­izes YONDELIS® in Europe and has other three clin­i­cal-stage pro­grams under development for several types of solid and hema­tological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharma­ceutical com­pany with sub­sid­i­aries in Germany, Italy, France, Switzerland, United Kingdom, Belgium and the United States. PharmaMar fully owns other com­panies: GENOMICA, Spain's leading molecular diagnostics com­pany; Sylentis, dedicated to researching thera­peutic appli­ca­tions of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at www.pharmamar.com.

Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the com­pany. Moreover, no reliance should be placed upon this document for any investment de­ci­sion or contract and it does not constitute a recom­men­da­tion of any type with regard to the shares of the com­pany.

References

1. http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-it
2. http://www.myeloma.org.uk/information/what-is-myeloma/
3. http://seer.cancer.gov/statfacts/html/mulmy.html
4. http://www.esmo.org/Guidelines/Haematological-Malignancies/Multiple-Myeloma

Source: PharmaMar.