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( BW)(CELGENE-INTERNATIONAL)(CELG) Cancer Drug REVLIMID(R) Receives
Recommendation for Approval from Australian Drug Evaluation Committee
for Treatment of Multiple Myeloma
Business Editors/Health/Medical Writers
NEUCHATEL, Switzerland--(BUSINESS WIRE)--Nov. 12, 2007--Celgene
International Sarl (NASDAQ: CELG) announced that its oral cancer drug
REVLIMID (lenalidomide) has received recommendation for approval from
the Australian Drug Evaluation Committee (ADEC) for use in combination
with dexamethasone as a treatment for patients with multiple myeloma
whose disease has progressed after one therapy. Multiple myeloma is
the second most commonly diagnosed blood cancer.
ADEC's recommendation for approval will be forwarded to the
Therapeutic Goods Administration (TGA) for ratification. The TGA
generally supports the recommendations of the ADEC and grants
marketing approval after the final prescribing information is
negotiated and certificates of registration are issued. This process
can take anywhere from two to six weeks.
"The ADEC recommendation is an especially important and positive
milestone for Celgene. We are fully committed to provide REVLIMID to
patients in need throughout Australia," said Aart Brouwer, President
of Celgene International. "We're optimistic that REVLIMID will have
broad support based on its clinical benefits to patients. Upon
approval we will be initiating the next steps for pricing,
reimbursement and distribution." The recommendation for approval from
the ADEC 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 whose disease
has progressed after one therapy.
"The recommendation for approval of REVLIMID from ADEC is an
important step towards providing a new oral therapeutic option in
Australia for this particular group of patients with multiple
myeloma," said Graham Burton, M.D., SVP, Global Regulatory Affairs and
Pharmacovigilance for Celgene. "We will continue our work with the
Australian authorities to bring REVLIMID to patients in need as
quickly as possible."
REVLIMID is currently also approved in the United States by the
U.S. Food and Drug Administration (FDA), in the European Union by the
EMEA and in Switzerland for multiple myeloma patients who have
received at least one prior therapy. In addition, REVLIMID is also
approved in the US 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, US, Switzerland and Australia for treatment of multiple
myeloma and in the EU, US and Australia for MDS.
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 over 100 clinical trials in a broad range
of hematological and oncological conditions. The IMiDs pipeline is
covered by a comprehensive intellectual property estate of issued and
pending patent applications in the US, EU and other regions, including
composition-of- matter and use patents.
REVLIMID has obtained Orphan Drug designation in the EU, US and
Australia for treatment of Multiple Myeloma and is already approved
for use as a treatment in combination with dexamethasone for patients
previously treated with multiple myeloma by the U.S. Food and Drug
Administration (FDA). REVLIMID is also approved 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 by the FDA.
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 ADEC
The Australian Drug Evaluation Committee is appointed by the
Minister for Health and Aging and provides advice to the Minister and
the Secretary of the Commonwealth Department of Health and Aging
through the Therapeutic Goods Administration (TGA), on the quality,
risk-benefit, effectiveness and access within a reasonable time of any
drug referred to it for evaluation, as well as medical and scientific
evaluations of applications for registration of prescription drugs.
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 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 .
REVLIMID(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.
CONTACT: Celgene Corporation
Sr. Vice President and Chief Financial Officer
David W. Gryska, 908-673-9059
or
Vice President, Global Corporate Communications
Brian P. Gill, 908-673-9530
KEYWORD: NEW JERSEY AUSTRALIA SWITZERLAND INTERNATIONAL ASIA
PACIFIC EUROPE
INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY ALTERNATIVE
MEDICINE MARKETING AGREEMENTS
SOURCE: Celgene International Sarl
Copyright Business Wire 2007
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