Celgene International Sarl (NASDAQ: CELG) today announced that
amrubicin hydrochloride has been designated as an orphan medicinal
product by the European Commission (EC) for the treatment of small
cell lung cancer following the favorable opinion of the European
Medicines Agency´s (EMEA) Committee for Orphan Medicinal Products
(COMP).
Criteria for designation of orphan medicinal product require that
the product be intended for the treatment of life-threatening or
serious conditions that are rare and affect not more than 5 in 10,000
persons in the EU. In the European Union, small cell lung cancer
affects more than 57,000 people and approximately 34,000 new cases of
the disease will be diagnosed this year.
Orphan medicinal product designation is granted by the EC to
provide special incentives for sponsors planning to test a product for
use in a rare disease or condition. These incentives include
eligibility for protocol assistance and possible exemptions or
reductions of certain regulatory fees during development or at the
time of application for marketing approval. Orphan designation will
provide amrubicin with 10 years of marketing exclusivity following
marketing approval for the treatment of small cell lung cancer.
"The decision by the European Commission to designate amrubicin
hydrochloride an orphan medicinal product continues our efforts to
deliver innovative therapies worldwide to patients in areas of great
unmet medical need such as solid tumor cancers," said Graham Burton
M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene
Corporation.
In March 2008, the Company also announced that the U.S. Food and
Drug Administration has granted orphan drug designation for amrubicin
in the treatment of small cell lung cancer.
About Amrubicin
Amrubicin is a third-generation, synthetic anthracycline analogue
with potent anti-tumor activity against various human tumor xenografts
and is a strong topoisomerase II inhibitor. Amrubicin is being studied
as a single agent and in combination with anti-cancer therapies for
small cell lung cancer.
Amrubicin is currently approved and marketed in Japan for the
treatment of both small cell lung cancer and non-small cell lung
cancer by Nippon Kayaku, a Japanese pharmaceutical firm focused on
oncology, which licensed Japanese marketing rights from Dainippon
Sumitomo Pharma, the original developer of the therapy. Dainippon
Sumitomo also licensed the North American and European marketing
rights for amrubicin to Pharmion Corporation, which was acquired by
Celgene Corporation in March 2008.
About Small Cell Lung Cancer
Small cell lung cancer is a disease in which malignant cells form
in the tissues of the lung, and nearly all cases are attributable to
cigarette smoking, with the remaining cases thought to be caused by
environmental or genetic factors. While small cell lung cancer
constitutes approximately 15 percent of all lung cancers, SCLC tends
to be more aggressive and fast growing than the more common non-small
cell lung cancer. An estimated 66,000 patients are diagnosed with SCLC
each year in the US and EU (approximately 32,000 in the US and 34,000
in the EU). Approximately 60 percent of patients have extensive
disease at diagnosis, and the remaining 40 percent present with
localized, or limited stage, disease.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, Switzerland, is a
wholly owned subsidiary and the international headquarters of Celgene
Corporation. Celgene Corporation, headquartered in Summit, New Jersey
is an integrated global pharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through gene and protein regulation. For more information, please
visit the Company´s website at www.celgene.com.
This release contains forward-looking statements which are subject
to known and unknown risks, delays, uncertainties and other factors
not under the Company´s control, which may cause actual results
performance or achievements of the Company to be materially different
from the results, performance or other expectations expressed or
implied by these forward-looking statements. These factors include
results of current or pending research and development activities
actions by the FDA and other regulatory authorities, and other factors
described in the Company´s filings with the Securities and Exchange
Commission such as our 10K, 10Q and 8K reports.
