04.09.2007 11:30:00
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Oral Cancer Drug REVLIMID(R) Receives Swissmedic Approval in Switzerland for Treatment of Multiple Myeloma
Celgene International Sàrl (NASDAQ: CELG)
announced today that its innovative oral cancer drug REVLIMID
(lenalidomide) has been granted approval by the Swiss Agency for
Therapeutic Products (Swissmedic) for use in combination with
dexamethasone as a treatment for patients with multiple myeloma who have
received at least one prior therapy. This approval represents the first
regulatory approval for Celgene in Switzerland, and REVLIMID represents
the first breakthrough oral therapy in Switzerland for multiple myeloma
patients in more than forty years.
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 2007.
"The opportunity to offer REVLIMID as an oral
therapy to our patients, gives a new structure to the way multiple
myeloma is treated and means important progress”,
says Dr. Taverna, Head of Oncology, at the hospital of Münsterlingen.
"For us as treating physicians it is of high
importance that companies such as Celgene support clinical research. For
the treatment of patients with multiple myeloma we have now two
multinational, randomized trials, demonstrating the superior efficacy of
REVLIMID in combination with Dexamethasone, compared to Dexamethasone
alone.” "The Swiss approval of REVLIMID is an
especially important and positive milestone for Celgene, as well as an
important step toward achieving our global mission of making innovative
oral therapies available to patients with significant unmet medical
needs worldwide,” said Aart Brouwer, President
of Celgene International. We are working diligently with Swissmedic to
determine next steps for pricing, reimbursement and distribution so that
REVLIMID is available for eligible patients in Switzerland as quickly as
possible.”
The Marketing Authorization Application (MAA) for REVLIMID 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, evaluating REVLIMID plus
dexamethasone in multiple myeloma patients that have received at least
one prior therapy.
"REVLIMID represents a significant advancement
in the treatment of multiple myeloma and we are fully committed to
swiftly bringing this new oral therapeutic option to patients in need
across Europe,” said Graham Burton, M.D., SVP,
Global Regulatory Affairs and Pharmacovigilance for Celgene. "We
remain committed to the broad and global clinical development of our
investigational therapies being studied in blood and solid tumor
cancers, and we are grateful that our collaborative efforts have
resulted in this approval of REVLIMID.”
REVLIMID has obtained Orphan Drug designation in the EU, US and
Australia for treatment of multiple myeloma. REVLIMID is approved for
use as an oral treatment in combination with dexamethasone by the
European Commission, following the recommendation from the European
Medicines Agency (EMEA). REVLIMID is currently approved in the US by the
U.S. Food and Drug Administration (FDA) for multiple myeloma patients
who have received at least one prior therapy. REVLIMID is also approved
in the US, by the FDA, for 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.
About REVLIMID®
REVLIMID is an IMiDs®
compound, a member of a proprietary group of novel immunomodulatory
agents. REVLIMID and other IMiDs compounds continue to be evaluated in
over 75 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 U.S. and foreign issued
and pending patent applications including composition-of-matter and use
patents.
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 Swissmedic
Swissmedic is the central Swiss supervisory authority for therapeutic
products. To protect humans and animals, Swissmedic ensures that only
high-quality, safe and effective medicines and medical devices are
placed on the market in Switzerland. Swissmedic is a public service
organization of the federal government with headquarters in Bern. It is
independent in its organization and management and has its own separate
budget. Swissmedic is linked to the Federal Department of Home Affairs
(FDHA). The Agency Council is its highest body and represents Swissmedic
in contacts with the FDHA and the Federal Council (the Swiss
government). It also approves Swissmedic's annual budget, annual
accounts, and annual report.
About Celgene International Sárl
Celgene International Sárl, located in
Boudry, in the Canton of Neuchâtel,
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®
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.
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