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

Hatfield, England (ots/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/kappa)
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(R), 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/mali
gnant_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:e
n: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

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

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April Kenneally, +44(0)207-798-9999 / +44(0)207-798-9263,
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