As ex­pec­ted after the Company announcement of the 8th of November, the Committee for Medicinal Products for Human Use (CHMP), belonging to the EMA, has emitted an opinion against the approval of Aplidin® for the treat­ment of multiple myeloma.

Madrid, Spain (Press Release) – As ex­pec­ted in the announcement made by PharmaMar on November 8th, the Committee for Medicinal Products for Human Use (CHMP) has finally emitted its opinion against the approval of the Marketing Authorization Application (MAA) of Aplidin® (plitidepsin), for the treat­ment of patients with re­lapsed multiple myeloma, in com­bi­na­tion with dexa­meth­a­soneⁱ.

After the opinion of the CHMP, the European Com­mis­sion will be in charge of emitting the final verdict, which could arrive around March or April, 2018.

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 and bor­tez­o­mib, and a Phase II in patients with multiple myeloma refractory to lena­lidomide and bor­tez­o­mib. Further­more, a Phase II study in re­lapsed or refractory angio­immuno­blastic T-cell lym­phoma. A Phase III trial in multiple myeloma re­lapsed or refractory has been com­pleted. Plitidepsin has received orphan drug desig­na­tion in the European Union and the United States of America.

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood cancer, which accounts for 10% of all hemato­logical malig­nan­cies, this being caused by malignant plasma cells that very rapidly multiplyⁱⁱ. Normal plasma cells are white blood cells, which form part of the immune system, found in the bone marrow that produce the anti­bodies nec­es­sary for fighting in­fec­tionsⁱⁱⁱ. Abnormal cells produce a type of anti­body that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. In 2015, 26,850 new cases were diag­nosed in the US, and about 11,200 people died from this disease^iv. In Europe, the incidence is 4.5–6.0 out of 100 000 diag­nosed per year^v.

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 a pipe­line of drug can­di­dates and a robust R&D on­col­ogy pro­gram. PharmaMar develops and com­mer­cial­izes YONDELIS® in Europe and has other clin­i­cal-stage pro­grams under devel­op­ment for several types of solid and 2 hema­to­logical cancers, Zepsyre™ (PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global bio­pharma­ceu­tical com­pany with sub­sid­i­aries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other com­pa­nies: GENOMICA, a 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

ⁱ https://www.pharmamar.com/wp-content/uploads/2017/11/HR-ENG-8-NOV-2017.pdf
ⁱⁱ http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-it
ⁱⁱⁱ http://www.myeloma.org.uk/information/what-is-myeloma/
^iv http://seer.cancer.gov/statfacts/html/mulmy.html
^v http://www.esmo.org/Guidelines/Haematological-Malignancies/Multiple-Myeloma

Source: PharmaMar.