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Chugai Pharma Europe Announces Positive Phase III Results of Aplidin®

Chugai Pharma Europe Ltd. (CPE), a wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. (TOKYO:4519), announced today positive results of a Phase III clinical trial called “ADMYRE” conducted by PharmaMar, with Aplidin® (plitidepsin) in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM). The study achieved its primary endpoint with a statistically significant extension in progression free survival (PFS) compared with dexamethasone alone, as announced by PharmaMar on 31 March.

For a long time, CPE has been committed to the treatment of hematologic oncology. It obtained promotion rights of Aplidin for the treatment of MM in eight European countries (France, Germany, the UK, Belgium, the Netherlands, Luxemburg, Ireland and Austria) under a licensing agreement with PharmaMar in July 2014.

"This is a positive step forward for our shared vision with PharmaMar to introduce a new treatment for relapsed Multiple Myeloma and we are confident that Aplidin's mechanism of action and strong supporting data will lead to a successful introduction of this novel drug for the benefit of patients" said John Halls, Managing Director of Chugai Pharma Europe.

This pivotal, randomized, open-label, international, multicenter Phase III clinical trial 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 for MM. A full evaluation of the final ADMYRE data will be presented at an upcoming medical meeting.

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 multiply1 . 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 infections2 . 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 disease3 . In Europe, the incidence is 4.5–6.0 out of 100,000 diagnosed per year4 .

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 Chugai Pharma Europe

Chugai Pharma Europe based in London, is the headquarters of all Chugai’s clinical development, regulatory affairs, medical affairs, import, sales and marketing of pharmaceutical products in Europe and coordinates the European marketing operations through subsidiaries located in the UK, France, and Germany. Products which are currently marketed in those countries include “RoActemra® (tocilizumab)”, a humanized anti-human IL-6 receptor monoclonal antibody, “Granocyte® (lenograstim)”, a G-CSF preparation, “Antepsin® (sucralfate)”, an antiulcer agent (marketed in the UK and Ireland), “Akynzeo® (netupitant-palonosetron)”, and “Aloxi® (palonosetron)” antiemetic agents (marketed in the UK). Furthermore, CPE is conducting the clinical development of SA237, an anti-IL-6 receptor humanized monoclonal antibody for the treatment of neuromyelitis optica, and CIM331 (nemolizumab), an anti-IL-31 receptor humanized monoclonal antibody for the treatment of atopic dermatitis.

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 .






Chugai Pharma France SAS
Nathalie Leroy, +33-1-56-37-05-21



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