Thalidomide Pharmion(TM) Granted Full Marketing Authorization for Treatment of Newly Diagnosed Multiple Myeloma in the European Union
Celgene International Sarl (NASDAQ: CELG) announced that
Thalidomide Pharmion has been granted full marketing authorization by
the European Commission for use in combination with melphalan and
prednisone as a treatment for patients with newly diagnosed multiple
myeloma. In June 2007, the European Commission granted the Company´s
REVLIMID(R) full marketing authorization as the first oral treatment
in more than 40 years for patients with multiple myeloma who have
received at least one prior therapy. These approvals confirm the
leading role of Celgene in blood cancer research and innovative oral
therapies.
Multiple myeloma is the second most commonly diagnosed blood
cancer. According to the International Myeloma Foundation, there are
an estimated 750,000 people with multiple myeloma worldwide. There are
more than 85,000 men and women in Europe currently undergoing
treatment for multiple myeloma, and 25,000 people are expected to die
from this blood cancer in 2008.
"The European Union authorization of Thalidomide Pharmion is an
important and positive milestone for men and women newly diagnosed
with multiple myeloma. When coupled with the approval of REVLIMID and
dexamethasone in 2007, Celgene is advancing its goal of delivering
vital therapies to people in need worldwide," said Aart Brouwer
President of Celgene International. "We are working diligently with
local regulatory authorities to determine next steps for pricing
reimbursement and distribution plans for all European Union member
states so that Thalidomide Pharmion will be available for eligible
patients as quickly as possible."
About Thalidomide
THALOMID(R) (thalidomide) researched, developed and commercialized
by Celgene Corporation, received U.S. Food and Drug Administration
(FDA) approval on May 25, 2006 as an oral treatment in combination
with dexamethasone for patients newly diagnosed with multiple myeloma.
In 2008, the Australian Drug Evaluation Committee (ADEC) granted
Thalidomide Pharmion(TM) marketing approval for use in combination
with melphalan and prednisone for patients with untreated multiple
myeloma or ineligible for high dose chemotherapy. Additionally
Thalidomide Pharmion was granted marketing approval in combination
with dexamethasone for induction therapy prior to high dose
chemotherapy with autologous stem cell rescue, for the treatment of
patients with untreated multiple myeloma. In 2003, ADEC approved
Thalidomide Pharmion, as a monotherapy, for treatment for patients
with multiple myeloma after failure of standard therapies.
THALOMID received FDA clearance in 1998, and Thalidomide Pharmion
received TGA approval, in 2003, for the acute treatment of cutaneous
manifestations of moderate to severe erythema nodosum leprosum (ENL)
and as maintenance therapy for prevention and suppression of the
cutaneous manifestations of ENL recurrence. Thalidomide is not
indicated as monotherapy for ENL treatment in the presence of moderate
to severe neuritis.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is
a cancer of the blood in which malignant plasma cells are overproduced
in the bone marrow. Plasma cells are white blood cells that help
produce antibodies called immunoglobulins that fight infection and
disease. However, most patients with multiple myeloma have cells that
produce a form of immunoglobulin called paraprotein (or M protein)
that does not benefit the body. In addition, the malignant plasma
cells replace normal plasma cells and other white blood cells
important to the immune system. Multiple myeloma cells can also attach
to other tissues of the body, such as bone, and produce tumors. The
cause of the disease remains unknown.
About Celgene International Sarl
Celgene International Sarl, located in Boudry, in the Cantone of
Neuchatel, Switzerland, is a wholly owned subsidiary and international
headquarters of Celgene Corporation. Celgene Corporation
headquartered in Summit, New Jersey, is an integrated global
biopharmaceutical 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.
THALOMID(R) is a registered trademark and Thalidomide Pharmion(TM)
is a trademark of Celgene Corporation.
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.