Welcome!

News Feed Item

European Commission Grants Orphan Drug Status to Eisai's Amatuximab for the Treatment of Malignant Mesothelioma

HATFIELD, England, January 22, 2014 /PRNewswire/ --

The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted orphan drug designation (ODD) for the treatment of malignant mesothelioma by the European Commission.

Malignant mesothelioma is a rare form of cancer that affects an estimated 1 in 50,000 (0.2/10,000) people per year in Europe.[1] Studies have shown highest incidence in the UK and Ireland and lowest in Eastern Europe.[1] This aggressive form of lung cancer is caused by asbestos exposure and despite a dramatic decrease in asbestos use since the mid-70s its incidence is expected to increase.[2],[3]

Amatuximab has high affinity and specificity for mesothelin, a protein which is overexpressed in people with malignant mesothelioma. Amatuximab was discovered and developed through Morphotek, a subsidiary wholly owned by Eisai.

"Eisai is dedicated to providing new options for people with difficult-to-treat diseases. The ODD for amatuximab highlights the need for new effective treatments for people with malignant mesothelioma and the potential for this investigational drug," says Gary Hendler, President & CEO Eisai EMEA & Russia.

Nick Nicolaides, President and Chief Executive Officer at Morphotek, commented: "We are extremely pleased that amatuximab has received ODD for the treatment of malignant pleural mesothelioma in Europe. This reinforces our commitment to develop safe and effective treatment options for patients suffering from an extremely invasive but rare disease."

ODD is for medicines developed for the diagnosis, prevention or treatment of rare diseases that are very serious or life-threatening. In the European Union (EU), a disease is defined as rare if it affects fewer than five in 10,000 people across the EU.[4]

The development of amatuximab underscores Eisai's human health care mission, the company's commitment to provide innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of oncology and addressing the unmet medical needs of patients and their families.

Notes to Editors

Amatuximab

Amatuximab is a chimeric immunoglobulin G-1-kappa (IgG1/κ) monoclonal antibody with high affinity and specificity for mesothelin, a glycoprotein currently considered an important target of mesothelioma treatment, due to its overexpression on tumour cells.[5]

About Malignant Mesothelioma

Mesothelioma is an aggressive and invasive form of lung cancer which originates from mesothelial cells in the inner lining of the pleural, peritoneal and pericardial cavities.

The primary cause of malignant mesothelioma is asbestos exposure. Symptoms of mesothelioma are unspecific and this causes significant delay in diagnosis. The median survival from the time of diagnosis is 9-12 months.[6]

About Morphotek

Morphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology.  The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications.  The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.  

For more information, please visit http://www.morphotek.com

About Eisai

Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).

Eisai concentrates its R&D activities in three key areas:

  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
  • Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
  • Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, Russia and the Middle East.

For further information please visit our web site http://www.eisai.co.uk

Date of preparation: January 2014        

Job code: Dev-UK0044

References

1. Calculated from; Seisling S, et al. Rare thoracic cancers, including peritoneum mesothelioma. Eur J Cancer. 2012; 48(7):949-60 and Musk AW, et al. Predicting survival in malignant mesothelioma. Eur Resp J. 2011;38(6):1420-4. Calculated using the Pisani method; Pisani P, Bray F, Parkin M. Estimates of the world-wide prevalence of cancer for 25 sites in the adult population. Int J of Cancer. 2002;97(1):72-81

2. National Cancer Intelligence Network. Malignant Pleural Mesothelioma. http://www.ncin.org.uk/publications/data_briefings/malignant_pleural_mesothelioma. Last accessed January 2014

3. Riaz, S.P et al. Mesothelioma incidence projections. Kings College London. http://www.ncin.org.uk/view?rid=276

4. Regulation (EC) No 141/2000 of the European Parliament and of the Council. Official Journal of the European Communities. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001.... Last accessed 14 January 2014

5. Clinical Trials.gov. http://clinicaltrials.gov/show/NCT01413451. Last accessed 2 January 2014

6. Robinson BW et al. Malignant mesothelioma. Lancet. 2005; 366: 397-408

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
WebRTC adoption has generated a wave of creative uses of communications and collaboration through websites, sales apps, customer care and business applications. As WebRTC has become more mainstream it has evolved to use cases beyond the original peer-to-peer case, which has led to a repeating requirement for interoperability with existing infrastructures. In his session at @ThingsExpo, Graham Holt, Executive Vice President of Daitan Group, will cover implementation examples that have enabled ea...
Kubernetes is a new and revolutionary open-sourced system for managing containers across multiple hosts in a cluster. Ansible is a simple IT automation tool for just about any requirement for reproducible environments. In his session at @DevOpsSummit at 18th Cloud Expo, Patrick Galbraith, a principal engineer at HPE, discussed how to build a fully functional Kubernetes cluster on a number of virtual machines or bare-metal hosts. Also included will be a brief demonstration of running a Galera M...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they mana...
IoT offers a value of almost $4 trillion to the manufacturing industry through platforms that can improve margins, optimize operations & drive high performance work teams. By using IoT technologies as a foundation, manufacturing customers are integrating worker safety with manufacturing systems, driving deep collaboration and utilizing analytics to exponentially increased per-unit margins. However, as Benoit Lheureux, the VP for Research at Gartner points out, “IoT project implementers often ...
The Jevons Paradox suggests that when technological advances increase efficiency of a resource, it results in an overall increase in consumption. Writing on the increased use of coal as a result of technological improvements, 19th-century economist William Stanley Jevons found that these improvements led to the development of new ways to utilize coal. In his session at 19th Cloud Expo, Mark Thiele, Chief Strategy Officer for Apcera, will compare the Jevons Paradox to modern-day enterprise IT, e...