CHUGAI-PHARMA-EUROPE
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 www.pharmamar.com .
| References | ||
| 1. |
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma |
|
| 2. | ||
| 3. | ||
| 4. |
http://www.esmo.org/Guidelines/Haematological-Malignancies/Multiple-Myeloma |
|
View source version on businesswire.com: http://www.businesswire.com/news/home/20160404005449/en/
Contact:
Chugai Pharma France SAS
Nathalie Leroy, +33-1-56-37-05-21
pr@chugai.eu
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Lenovo Group: Second Quarter Financial Results 2025/2620.11.2025 00:45:00 CET | Press release
Lenovo delivers record quarterly results, marking significant progress in hybrid AI Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported record results for the second quarter of fiscal year 2025/26, with overall group revenue reaching an all-time high of US$20.5 billion, up 15% year-on-year. Adjusted net income[1] grew 25% year-on-year to US$512 million, and adjusted net income margin expanded to 2.5%, driven by higher revenues. Together, these reflect the strength of the Group’s operational performance as they exclude the impact of non-cash fair value loss on warrants, notional interest on convertible bonds, and other non-cash items. The Group delivered double-digit year-on-year revenue growth across all main business groups and sales geographies. The AI-related revenue mix increased by 13 percentage points year-on-year, accounting for 30% of the Group’s total revenue this quarter. The growth was driven by high-double-digit revenue
OCP Announces Date of Third Quarter and Nine-Month 2025 Earnings19.11.2025 22:05:00 CET | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its third quarter and nine-month 2025 results on Tuesday, November 25, 2025. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 9:00 a.m. EDT, 3:00 p.m. Morocco (GMT+1), and 2:00 p.m. London time (GMT). OCP senior management will host a conference call to discuss third quarter and nine-month 2025 results at 10:00 a.m. EDT, 4:00 p.m. Morocco (GMT+1), and 3:00 p.m. London time (GMT) on Tuesday, November 25, 2025, for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s
Marquee Brands Broadens Global Portfolio with Strategic Acquisition of Stance19.11.2025 21:00:00 CET | Press release
Marquee’s 19th Brand Signals a Bold Expansion into Lifestyle and Performance Marquee Brands, the premier global brand accelerator, today announced the acquisition of Stance, the innovative lifestyle and performance sock brand. Founded in 2009 in San Clemente, California, Stance joins Marquee Brands’ renowned portfolio, home to some of the world’s most notable brands, including Martha Stewart, Laura Ashley, Sur La Table, BCBG, Ben Sherman, Body Glove and Dakine. The addition of Stance brings total retail sales across Marquee’s portfolio to $4.5 Billion USD. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251119216623/en/ Marquee also announces a new partnership with United Legwear and Apparel Co. (ULAC), which becomes the brand’s core global licensee, managing operations across all territories apart from China. With products sold in 42 countries through more than 1,100 U.S. wholesale accounts, e-commerce, international distrib
AWS and HUMAIN Expand Partnership with NVIDIA AI Infrastructure and AWS AI Chip Deal to Drive Global AI Innovation19.11.2025 19:38:00 CET | Press release
Expanded partnership includes deployment of up to 150,000 AI accelerators including the latest NVIDIA GB300s AI infrastructure and AWS’s Trainium chips.Amazon Bedrock will provide customers access to best-in-class foundation models optimized across diverse, high performance AI chip infrastructures.AWS becomes HUMAIN’s preferred AI partner with AWS and HUMAIN collaborating to bring AI compute and services to customers worldwide. Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), and HUMAIN, a Public Investment Fund (PIF) company delivering global full-stack AI solutions, announced today at the U.S.-Saudi Investment Forum their plans to provide, deploy and manage up to 150,000 AI accelerators in a data center facility known as an “AI Zone” in Riyadh. As part of the expanded partnership, AWS will become HUMAIN’s preferred AI partner globally, and the two companies will collaborate to bring AI compute and services from Saudi Arabia to customers worldwide. This pre
Luma AI Raises $900 Million Series C Led by HUMAIN And Partners on 2 Gigawatt AI Supercluster in Saudi Arabia19.11.2025 18:15:00 CET | Press release
New capital and compute infrastructure will accelerate Luma AI’s path towards Multimodal AGI – AI that can simulate reality and help humans in the physical world.HUMAIN to build Project Halo, one of the world’s largest AI compute clusters that will include the training of World Models, the next step in AI after LLMs - a potential trillion-dollar opportunity spanning entertainment, marketing/brands, education, world understanding, and robotics industries.Partnership includes HUMAIN Create, an initiative to build AI models trained on Arabic and regional data, helping enterprises and governments across MENA adopt culturally aligned AI. Luma AI, the frontier artificial intelligence company building multimodal AGI, today announced it has raised $900 million in Series C funding, led by HUMAIN, a PIF company delivering global full-stack AI solutions, with significant participation from AMD Ventures, and existing investors Andreessen Horowitz, Amplify Partners, and Matrix Partners. This press
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom