Exhibit 99.1
Contact: David W. Gryska Brian P. Gill
Sr. Vice President and Vice President,
Chief Financial Officer Corporate Communications
Celgene Corporation Celgene Corporation
(908) 673-9059 (908) 673-9530
ORAL CANCER DRUG REVLIMID(R) RECEIVES POSITIVE
OPINION FOR TREATMENT OF MULTIPLE MYELOMA FROM
EUROPEAN MEDICINES AGENCY
NEUCHATEL, SWITZERLAND - (MARCH 23, 2007) - CELGENE INTERNATIONAL SARL (NASDAQ:
CELG) announced today that its innovative oral cancer drug REVLIMID
(lenalidomide) has received a positive opinion from the European Medicines
Agency (EMEA) for use in combination with dexamethasone as a treatment for
patients with multiple myeloma who have received at least one prior therapy. The
EMEA's Committee for Medicinal Products for Human Use (CHMP), which reviews
applications for all 27 Member States in the European Union (EU) as well as
Norway and Iceland, has recommended approval for REVLIMID. The CHMP's positive
opinion will be forwarded to the European Commission that generally follows the
recommendation of the CHMP and issues final marketing approval within two to
three months.
Multiple myeloma is the second most commonly diagnosed blood cancer. According
to the International Myeloma Foundation, there are an estimated 750,000 people
with MM worldwide. There are more than 85,000 men and women in Europe undergoing
treatment for multiple myeloma, and 25,000 people are expected to die from this
blood cancer in 2007.
"The CHMP recommendation is an especially important and positive milestone for
Celgene. We are fully committed to deliver REVLIMID to patients in need
throughout the EU," said Aart Brouwer, President of Celgene International.
"We're optimistic that REVLIMID will have broad support based on its value to
patients and to the healthcare system. Upon approval we are prepared to initiate
next steps for pricing, reimbursement and distribution plans for all EU member
states."
The positive opinion from the CHMP 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.
"The positive opinion of REVLIMID from the CHMP is an important step forward
towards providing a new oral therapeutic option for this particular group of
patients with multiple myeloma," said Graham Burton, M.D., SVP, Global
Regulatory Affairs and Pharmacovigilance for Celgene. "We are committed to
continue our work with the European authorities to bring REVLIMID to patients in
need as quickly as possible."
Upon the European Commission's approval for REVLIMID as an oral combination
treatment with dexamethasone for multiple myeloma patients who have received at
least one prior therapy, Celgene Europe will initiate next steps for marketing,
distribution, pricing and reimbursement approvals for all EU member states.
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 75 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 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.
# # #