Celgene International Sarl (NASDAQ: CELG) today announced the
results of regulatory actions regarding REVLIMID(R) in Australia in
multiple myeloma (MM), and in Canada and the European Union in
deletion 5q myelodysplastic syndromes (MDS).
In Australia, REVLIMID (lenalidomide) has received marketing
authorisation approval from the Australian Therapeutic Goods
Administration (TGA) for use in combination with dexamethasone as a
treatment for patients with multiple myeloma whose disease has
progressed after one therapy.
The approval from the TGA was based upon the safety and efficacy
results of two large, randomized pivotal Phase III special protocol
assessment trials, North American Trial MM-009 and International Trial
MM-010--each the focus of a recent study in The New England Journal of
Medicine--evaluating REVLIMID plus dexamethasone in multiple myeloma
patients whose disease had progressed after one therapy.
Multiple myeloma is the second most commonly diagnosed blood
cancer worldwide.
In Canada, REVLIMID (lenalidomide) received conditional marketing
authorisation approval from the Canadian Therapeutic Products
Directorate (TPD) for the treatment of patients with
transfusion-dependent anemia due to low- or intermediate-1-risk MDS
associated with a deletion 5q cytogenetic abnormality with or without
additional cytogenetic abnormalities.
The approval by the TPD was based upon the safety and efficacy
results of a Phase II clinical trial (MDS-003) evaluating REVLIMID(R)
in patients with transfusion-dependent anemia due to low- or
intermediate-1-risk myelodysplastic syndromes (MDS) associated with a
deletion 5q cytogenetic abnormality with or without additional
cytogenetic abnormalities. Additionally, the U.S. FDA approved
REVLIMID in December 2005 for the same indication based on this trial.
"The approvals for REVLIMID in Australia and Canada in two
different indications continue our stated goal of delivering REVLIMID
as an innovative oral therapy to patients worldwide as quickly as
possible," said Aart Brouwer, President of Celgene International.
In the European Union, the European Medicines Agency´s (EMEA)
Committee for Medicinal Products for Human Use (CHMP) issued a
Negative Opinion on the Company´s Marketing Authorisation Application
(MAA) for Lenalidomide - Celgene Europe for the treatment of patients
with transfusion-dependent anemia due to low- or intermediate-1-risk
MDS associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities.
The CHMP concluded that lenalidomide is efficacious in patients
suffering from deletion 5q MDS. Based on information available to the
CHMP from the uncontrolled, open-label, 148-patient Phase II study
(MDS-003), the CHMP was not convinced the data were sufficient to
assure safety. Celgene intends to apply for a re-examination of the
CHMP Opinion in accordance with relevant EMEA procedures.
"We remain convinced of the positive benefit/risk of lenalidomide
for the treatment of patients with deletion 5q minus MDS, and we look
forward to continuing work with the EMEA and CHMP to bring this
Marketing Authorisation Application to a positive outcome for patients
in the European Union," said Graham Burton, M.D., SVP, Global
Regulatory Affairs and Pharmacovigilance for Celgene.
Lenalidomide (REVLIMID(R)) has obtained Orphan Drug designation
for MDS in the European Union (EU), United States (US), and Australia,
Orphan Drug designation for multiple myeloma (MM) in the EU, US,
Australia and Switzerland, and Orphan Drug designation for chronic
lymphocytic leukemia (CLL) in the US and EU. REVLIMID is currently
approved for use in the US and Canada for the treatment of patients
with transfusion-dependent anemia due to low- or intermediate-1-risk
myelodysplastic syndromes (MDS) associated with a deletion 5q
cytogenetic abnormality with or without additional cytogenetic
abnormalities. REVLIMID is also approved for use in the EU, US and
Switzerland for the treatment of multiple myeloma in combination with
dexamethasone in patients who have received at least one prior
therapy, and Australia for patients with multiple myeloma whose
disease has progressed after one therapy.
About REVLIMID(R)
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 more than 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 issued and pending patent applications including
composition-of-matter and use patents.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic
malignancies that affect approximately 300,000 people worldwide.
Myelodysplastic syndromes occur when blood cells remain in an immature
or "blast" stage within the bone marrow and never develop into mature
cells capable of performing their necessary functions. Eventually, the
bone marrow may be filled with blast cells suppressing normal cell
development. According to the American Cancer Society, 10,000 to
20,000 new cases of MDS are diagnosed each year in the United States,
with median survival rates ranging from approximately six months to
six years for the different classifications of MDS. MDS patients must
often rely on blood transfusions to manage symptoms of anemia and
fatigue and may develop life-threatening iron overload and/or toxicity
from frequent transfusions, as well as a risk of transformation into
acute myelogenous leukemia as a natural progression of the disease,
thus underscoring the critical need for new therapies targeting the
cause of the condition rather than simply managing its symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than
half of patients with myelodysplastic syndrome (MDS), and involve a
deletion in all or part of one or more specific chromosomes. The most
common cytogenetic abnormalities in MDS are deletions in the long arm
of chromosomes 5, 7, and 20. Another common abnormality is an extra
copy of chromosome 8. A deletion involving the 5q chromosome may be
involved in 20 to 30 percent of all MDS patients. The World Health
Organization has also recently identified a unique subset of MDS
patients with a "5q- Syndrome" where the only chromosomal abnormality
is a specific portion of the 5q chromosome.
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, 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.
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.
