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



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

  PR Newswire

  HATFIELD, England, January 22, 2014

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

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908 314 155 / +44(0)7947-231-513, Cressida_Robson@eisai.net ,
Charlotte_Andrews@eisai.net. Tonic Life Communications, Siobhan Reilly / April
Kenneally, +44(0)207-798-9999 / +44(0)207-798-9263,
siobhan.reilly@toniclc.com, april.kenneally@toniclc.com
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