Thalidomide Pharmion(R) Receives Marketing Approval from Australian Therapeutic Goods Administration for Treatment of Newly Diagnosed Multiple Myeloma
Celgene International Sarl (NASDAQ: CELG) today announced the
Australian Therapeutic Goods Administration (TGA) approved a
supplemental filing granting Thalidomide Pharmion 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.
This marketing approval represents the first oral cancer therapy
ever registered for patients newly diagnosed with multiple myeloma in
Australia.
Thalidomide Pharmion was previously approved by the TGA in 2003 as
a treatment for patients with multiple myeloma after failure of
standard therapies. In January 2008, the TGA granted the Company´s
leading oral cancer therapy REVLIMID(R) full marketing approval for
use in combination with dexamethasone as a treatment for patients with
multiple myeloma whose disease has progressed after one therapy.
"The TGA approval of Thalidomide Pharmion for newly diagnosed
myeloma patients offers additional options in this critical disease
area. When coupled with the approval of REVLIMID and dexamethasone
earlier this year, we are advancing our goal of delivering vital
therapies to patients in need worldwide," said Aart Brouwer, President
of Celgene International. "Additionally, these approvals confirm our
leadership role in blood cancer research and innovative oral
therapies."
Multiple myeloma is the second most commonly diagnosed blood
cancer worldwide.
About Thalidomide Pharmion
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 2003, the Australian Drug Evaluation Committee 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 Pharmion 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 TGA
The Therapeutic Goods Administration is the regulatory body for
therapeutic goods in Australia. It is a Division of the Australian
Department of Health and Aging and is responsible for conducting
assessment and monitoring activities to ensure that therapeutic goods
available in Australia are of an acceptable standard and that access
to therapeutic advances is in a timely manner.
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 of Celgene Corporation.
Thalidomide Pharmion(R) is a registered 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.