Lenalidomide (REVLIMID(R)) Receives Orphan Medicinal Product Designation from the European Commission for Chronic Lymphocytic Leukemia
- 8:10 - 30/11/2007
Celgene International Sarl (NASDAQ: CELG) announced that
lenalidomide (REVLIMID) has been granted orphan medicinal product
designation by the European Commission (EC) for treatment of chronic
lymphocytic leukemia (CLL) following the favorable opinion of the
European Medicines Agency´s (EMEA) Committee for Orphan Medicinal
Orphan medicinal product designation is granted by the EC to
promote development of drugs to treat rare diseases or conditions.
Orphan designation will give lenalidomide (REVLIMID) access to the
Centralized Procedure for the application for marketing approval;
reduce fees associated with applying for marketing approval and
protocol assistance; and provide ten years of market exclusivity once
approved for treatment of chronic lymphocytic leukemia.
Chronic lymphocytic leukemia is a hematological cancer that
affects approximately 165,000 people in the European Union, based on
an estimated prevalence 3.5 per 10,000.
"The decision by the European Commission to designate REVLIMID as
an orphan medicinal product for treatment of chronic lymphocytic
leukemia supports our efforts to move REVLIMID as quickly as possible
through the clinical and regulatory development process worldwide,"
said Graham Burton M.D., SVP, Global Regulatory Affairs and
Pharmacovigilance for Celgene Corporation. "We continue to be
encouraged by the growing body of published and presented data on
REVLIMID by key opinion leaders at major medical meetings, and based
on these findings, we are committed to accelerating wherever possible
our efforts to help address the unmet medical needs of patients with
chronic lymphocytic leukemia worldwide."
Within the EU, Iceland and Norway, REVLIMID(R) (lenalidomide) is
authorized for marketing and, in combination with dexamethasone, is
indicated for the treatment of multiple myeloma patients who have
received at least one prior therapy.
REVLIMID is also currently approved in the United States by the
U.S. Food and Drug Administration (FDA) and in Switzerland for
multiple myeloma patients who have received at least one prior
therapy. Additionally, REVLIMID is approved in the United States for
treatment of patients with transfusion-dependent anemia due to low- or
intermediate-1-risk Myelodysplastic Syndrome (MDS) associated with a
deletion 5q cytogenetic abnormality with or without additional
cytogenetic abnormalities. REVLIMID has already obtained Orphan Drug
designation in the EU, United States, Switzerland and Australia for
the treatment of multiple myeloma and in the EU, Australia and United
States for treatment of MDS.
REVLIMID is an IMiDs(R) compound, a member of a proprietary group
of novel immunomodulatory agents. REVLIMID and other IMiDs compounds
continue to be evaluated in over 100 clinical trials in a broad range
of oncological conditions, both in blood cancers and solid tumors. The
IMiDs pipeline is covered by a comprehensive intellectual property
estate of United States and foreign issued and pending patent
applications including composition-of- matter and use patents.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia results from an acquired (not
inherited) injury to the DNA of a single cell, a lymphocyte, in the
bone marrow. This injury is not present at birth. Scientists do not
yet understand what produces this change in the DNA of CLL patients.
This change in the cell´s DNA confers a growth and survival advantage
on the cell, which becomes abnormal and malignant (leukemic). The
result of this injury is the uncontrolled growth of lymphocytic cells
in the marrow leading invariably to an increase of abnormal
lymphocytes in the blood and the bone marrow. These lymphocytes do not
perform their functions as normal ones would and interfere with the
production of other blood cells necessary for the normal functioning
of the blood, leading to a host of complications like deficiency of
the immune system, coagulation problems, swollen lymph nodes, and many
The European Medicines Agency (EMEA) is the European regulatory
body responsible for the authorization and supervision of medicinal
products for human and veterinary use in member European countries,
approximately twenty-seven to date. The agency has four key
objectives; (1) To protect public health by mobilizing the best
scientific resources existing within the European Union, (2) To
promote health care through the effective regulation of new
pharmaceuticals and better information for users and health
professionals, (3) To facilitate quicker access and the free
circulation of pharmaceuticals within the European single market, (4)
To support the European pharmaceutical research and development
industry by developing efficient, effective and responsive operating
About Celgene International Sarl
Celgene International Sarl, located in Boudry, Switzerland, is a
wholly owned subsidiary and 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.
REVLIMID(R) is a registered trademark of Celgene Corporation.
This release contains certain forward-looking statements which
involve 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 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 those factors detailed in
the Company´s filings with the Securities and Exchange Commission such
as Form 10-K, 10-Q and 8-K reports.