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:2000:018:0001:0005:en:PDF. 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