CHUGAI-PHARMA-EUROPE
4.4.2016 10:01:12 CEST | Business Wire | Press release
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
VELOCIFERO Takes Action Against Counterfeiting in China13.11.2026 17:32:00 CET | Press release
White s.r.o., exclusive owner of the VELOCIFERO brand, takes action in China to protect its intellectual property rights. Initial measures in Chongqing and Taizhou have already resulted in the seizure of vehicles alleged to be counterfeit. VELOCIFERO is taking action against counterfeiting in China. White s.r.o., the exclusive owner of the VELOCIFERO brand and its related intellectual property rights, has launched decisive measures to protect its creative and industrial assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261113797570/en/ Photo courtesy of White s.r.o. “Vehicle sealed in Chongqing as part of actions undertaken to protect VELOCIFERO’s intellectual property rights.” The matter originated in June 2026 when, according to the company’s complaint, computers were removed from the technical office of Taizhou Siweiluo, the company appointed to manufacture VELOCIFERO products. White s.r.o. subsequently became aware
LangChain Raises $300M to Enable Every Company to Own Their Intelligence13.11.2026 16:53:00 CET | Press release
CapitalG leads Series C funding round at a $3B valuation to advance LangChain's agent engineering platform LangChain today announced it has raised $300 million in new funding at a $3 billion valuation, bringing total funding to date to $460 million. The round was led by existing investor CapitalG, with significant participation from new investors GIC and DFJ Growth and existing investors IVP and Sapphire Ventures. LangChain is advancing its mission to help every company own its intelligence. As agents transform the economy, companies are building domain-specific agents differentiated by their knowledge, data, and user experience. These agents will power new products and transform internal company operations, creating lasting competitive advantages for the companies that control them. "Agents are going to transform how companies operate and the products they deliver. The companies that control these systems will build lasting competitive advantages," said Harrison Chase, Co-Founder and
Kinaxis Named a Leader in Five 2026 IDC MarketScapes for Worldwide Supply Chain Planning13.11.2026 13:00:00 CET | Press release
Maestro delivers concurrent planning on a single platform across discrete, process, consumer packaged goods and life sciences Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced it has been named a Leader in five 2026 IDC MarketScape vendor assessments for worldwide supply chain planning. The recognition spans the overall market and four industries - discrete industries, process industries, consumer packaged goods and life sciences industries - all served by a single platform, Kinaxis Maestro®, the company's AI-powered supply chain orchestration platform. "Supply chain leaders don't need a better forecast once a month. They need to know what changed this morning, what it means across the business, and what to do about it," said Andrew Bell, Chief Product Officer of Kinaxis. "I believe being named a Leader across five IDC MarketScape vendor assessments, in industries that plan in very different ways, shows that a single concurr
SBC Medical Announces Capital and Business Alliance with NeuroBrain Dynamics to Advance Clinic Profitability Through Medical AI13.11.2026 12:30:00 CET | Press release
Companies to co-develop six medical AI solutions targeting revenue expansion and cost reduction; SBC Medical secures priority sales rights in Japan and South Korea and targets B2B expansion across Asia SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced a strategic capital and business alliance agreement with NeuroBrain Dynamics Inc. (“NBD”), a Taipei-based company dedicated to enterprise generative AI solutions. As part of the agreement executed on November 13, 2026, SBC Medical has made a minority equity investment in NBD. Through this alliance, SBC Medical plans to introduce two complementary suites of generative AI solutions across its network of 287 clinics in Japan and overseas*: “revenue-growth AI,” to elevate average revenue per visit and customer retention through personalized customer guidance, and “cost-reduction AI,
SBC Medical Group Holdings Reports Third Quarter 2026 Financial Results13.11.2026 12:30:00 CET | Press release
Revenue Up 35%, Net Income Attributable to SBC Medical Up 22%, and Adjusted EBITDA1 Up 66% Year-over-Year; Net Income Margin of 27% and Adjusted EBITDA Margin of 47% — Previously Announced Service Fee Revisions and New Clinic Openings Contribute to Revenue Growth and Operating Margin Improvement SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields to medical institutions in Japan and abroad, today announced its consolidated financial results for the third quarter of fiscal year 2026 (the three months ended September 30, 2026) and the three cumulative quarters of fiscal year 2026 (the nine months ended September 30, 2026). Third Quarter 2026 Financial Highlights Total revenues were $59 million, up 35% year-over-year. Income from operations was $26 million, up 66% year-over-year, with an operating margin of 45%. Net income attributable to SBC Medi
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