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
Reply Expands Prebuilt AI Apps With New Production-Ready Applications to Accelerate Enterprise AI Adoption28.5.2026 10:00:00 CEST | Press release
Reply[EXM, STAR: REY] today released a new set of Prebuilt AI Apps: ready-to-use agentic applications designed to drive efficiency and business growth by accelerating the integration of AI into enterprise processes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528283268/en/ Prebuilt AI Apps are ready-to-use agentic applications designed to accelerate the integration of AI into enterprise processes, driving efficiency and supporting business growth. In developing the Prebuilt AI Apps, Reply has identified key areas within enterprise processes where AI can create tangible operational value and turned them intoreusable assets, combining deep process knowledge, curated datasets, domain ontologies and reusable agentic flows in robust, secure and production-ready solutions. Each application can be further customised and extended through integration with enterprise systems, internal data and knowledge bases, while maintaining
Klarna Partners With Arrive for Parking in 15 Markets28.5.2026 09:56:00 CEST | Press release
Klarna, the global digital bank and flexible payments provider, has partnered with Arrive, a leading global mobility platform, to bring seamless and flexible payment options to millions of consumers across 15 markets. Through the partnership, drivers will be able to pay for parking using Klarna’s Pay in Full, which will be available directly in Arrive’s EasyPark app, ensuring payments can be made instantly. This provides consumers with more flexibility and control over their everyday spending, and builds on Klarna's growing presence in everyday spending and saving, where consumers increasingly use Klarna for recurring, low-friction purchases alongside savings products like Klarna Balance. Arrive, formerly EasyPark Group, operates one of the world’s largest digital parking networks, facilitating high frequency payments across millions of spots in more than 20,000 cities and 90 countries. By providing the digital infrastructure that helps individuals and decision-makers make smarter urba
Navan Unlocks Savings for Travelers with First SAS NDC Direct Connect28.5.2026 09:01:00 CEST | Press release
Direct connection gives travelers access to lower fares and streamlined post-booking services Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced a New Distribution Capability (NDC) integration with Scandinavian Airlines (SAS). By allowing the airline to share its fares, availability, and offers directly in real time, the integration provides an expanded portfolio of SAS fares and services to Navan customers. This makes Navan the first Travel Management Company (TMC) to access SAS NDC content via a direct connection, leveraging version 21.3 of the NDC API. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528812727/en/ Direct connection gives travelers access to lower fares and streamlined post-booking services “Our Modern Airline Retailing journey is centered on delivering more relevant offers, greater transparency, and better value for travelers,” said Edward Fotheringham, VP S
KKR to Open New Office in Milan, Strengthening Long-Term Commitment to Italy28.5.2026 09:00:00 CEST | Press release
New office reflects KKR’s localisation strategy and opportunity in Italy’s evolving investment landscape KKR, a leading global investment firm, today announced plans to open an office in Milan, further strengthening its long-term commitment to Italy and expanding its local presence in one of Europe’s largest economies. The office will support the firm’s investment activity across Private Equity, Real Assets, Credit and Insurance, while deepening client partnerships and advancing the continued development of KKR’s private wealth business in Italy. Italy has been an important market for KKR for over two decades, with over €10 billion of capital deployed since 2005 across Private Equity, Real Assets and Credit. The firm’s investments include FiberCop, Europe’s first wholesale-only, open-access fibre network, Enilive, a key player in advancing Italy’s energy transition, and CMC, a sustainable packaging leader using robotics to drive innovation. These investments reflect KKR’s focus on part
Merz Therapeutics Presents New Research at World Parkinson Congress 2026, Revealing the Hidden Burden of "OFF" Episodes in Parkinson’s Disease28.5.2026 09:00:00 CEST | Press release
A new qualitative literature review provides a comprehensive model of the patient experience of OFF episodes, identifying 132 distinct motor, non-motor and quality-of-life impacts1 The research highlights OFF episode as a complex, multifaceted experience, highlighting the profound and often invisible struggles faced by people with Parkinson’s disease1 Additional analyses of levodopa inhalation powder (INBRIJA®) confirm its clinical profile as a rapid, reliable and well-tolerated on-demand treatment for OFF episodes2,3 Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced the presentation of new research at the World Parkinson Congress (WPC) 2026 that uncovers the multifaceted burden of "OFF" episodes in Parkinson's disease (PD). The qualitative literature review demonstrates that these episodes are not only a re-emergence of motor symptoms, but also a complex mix of debilitating motor and non-motor symptoms that impact the lives of people with Parki
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