Exhibit 99.1
Contact: Robert J. Hugin Brian P. Gill
President and COO Senior Director, PR/IR
Celgene Corporation Celgene Corporation
(908) 673-9102 (908) 673-9530
REVLIMID(R) IN COMBINATION WITH DEXAMETHASONE sNDA
GRANTED APPROVAL BY FDA FOR TREATMENT OF MULTIPLE MYELOMA
THIRD FDA APPROVAL FOR CELGENE CORPORATION IN SIX MONTHS
SUMMIT, NJ - (JUNE 29, 2006) - Celgene Corporation (NASDAQ: CELG) announced that
the U.S. Food and Drug Administration (FDA) has granted approval for its
Supplemental New Drug Application (sNDA) for an additional indication for
REVLIMID (lenalidomide), for use in combination with dexamethasone as a
treatment for patients with multiple myeloma who have received at least one
prior therapy. REVLIMID is also approved for use in the treatment of patients
with transfusion-dependent anemia due to Low-or-Intermediate-1-risk
myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality
with or without additional cytogenetic abnormalities. Multiple myeloma is the
second most common blood cancer in the United States, affecting approximately
50,000 people. About 14,600 new cases of multiple myeloma are diagnosed each
year and about 12,000 Americans are expected to die of multiple myeloma in 2006.
In the REVLIMID (lenalidomide)/dexamethasone treatment group, 151 patients (45%)
underwent at least one dose interruption with or without a dose reduction of
REVLIMID (lenalidomide) compared to 21% in the placebo/dexamethasone treatment
group. Most adverse events and Grade 3 or 4 adverse events were more frequent in
patients who received the combination of REVLIMID (lenalidomide)/dexamethasone
compared to placebo /dexamethasone.
"The FDA approval of REVLIMID offers a new oral therapeutic option to this
particular group of patients with multiple myeloma," said Graham Burton, M.D.,
SVP, Regulatory Affairs and Pharmacovigilance for Celgene.
REVLIMID will be available in the following strengths: 5 mg, 10 mg, 15 mg, and
25 mg capsules.
SAFETY NOTICE:
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WARNINGS:
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1. POTENTIAL FOR HUMAN BIRTH DEFECTS.
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LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN
TERATOGEN THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF
LENALIDOMIDE IS TAKEN DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO
AN UNBORN BABY. FEMALES SHOULD BE ADVISED TO AVOID PREGNANCY WHILE TAKING
REVLIMID(R) (LENALIDOMIDE).
SPECIAL PRESCRIBING REQUIREMENTS
BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO REVLIMID
(LENALIDOMIDE), REVLIMID (LENALIDOMIDE) IS ONLY AVAILABLE UNDER A SPECIAL
RESTRICTED DISTRIBUTION PROGRAM. THIS PROGRAM IS CALLED "REVASSIST(SM)". UNDER
THIS PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM CAN
PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, REVLIMID (LENALIDOMIDE) MUST
ONLY BE DISPENSED TO PATIENTS WHO ARE REGISTERED AND MEET ALL THE CONDITIONS OF
THE REVASSIST(SM) PROGRAM.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
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THIS DRUG IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND THROMBOCYTOPENIA.
EIGHTY PERCENT OF PATIENTS WITH DELETION 5Q MYELODYSPLASTIC SYNDROMES HAD TO
HAVE A DOSE DELAY/REDUCTION DURING THE MAJOR STUDY. THIRTY-FOUR PERCENT OF
PATIENTS HAD TO HAVE A SECOND DOSE DELAY/REDUCTION. GRADE 3 OR 4 HEMATOLOGIC
TOXICITY WAS SEEN IN 80% OF PATIENTS ENROLLED IN THE STUDY. PATIENTS ON THERAPY
FOR DELETION 5Q MYELODYSPLASTIC SYNDROMES SHOULD HAVE THEIR COMPLETE BLOOD
COUNTS MONITORED WEEKLY FOR THE FIRST 8 WEEKS OF THERAPY AND AT LEAST MONTHLY
THEREAFTER. PATIENTS MAY REQUIRE DOSE INTERRUPTION AND/OR REDUCTION. PATIENTS
MAY REQUIRE USE OF BLOOD PRODUCT SUPPORT AND/OR GROWTH FACTORS. (SEE DOSAGE AND
ADMINISTRATION)
3. DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM.
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THIS DRUG HAS DEMONSTRATED A SIGNIFICANTLY INCREASED RISK OF DEEP VENOUS
THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WITH MULTIPLE MYELOMA
WHO WERE TREATED WITH REVLIMID (LENALIDOMIDE) COMBINATION THERAPY. PATIENTS AND
PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE SIGNS AND SYMPTOMS OF
THROMBOEMBOLI(SM). PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL CARE IF THEY
DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR LEG
SWELLING. IT IS NOT KNOWN WHETHER PROPHYLACTIC ANTICOAGULATION OR ANTIPLATELET
THERAPY PRESCRIBED IN CONJUNCTION WITH REVLIMID (LENALIDOMIDE) MAY LESSEN THE
POTENTIAL FOR VENOUS THROMBOEMBOLIC EVENTS. THE DECISION TO TAKE PROPHYLACTIC
MEASURES SHOULD BE DONE CAREFULLY AFTER AN ASSESSMENT OF AN INDIVIDUAL PATIENT'S
UNDERLYING RISK FACTORS.
YOU CAN GET INFORMATION ABOUT REVLIMID (LENALIDOMIDE) AND THE REVASSIST(SM)
PROGRAM ON THE INTERNET AT www.REVLIMID.com OR BY CALLING THE MANUFACTURER'S
TOLL-FREE NUMBER AT 1-888-423-5436.
IMPORTANT SAFETY INFORMATION
HYPERSENSITIVITY: REVLIMID(R) (LENALIDOMIDE) IS CONTRAINDICATED IN ANY PATIENTS
WHO HAVE DEMONSTRATED HYPERSENSITIVITY TO THE DRUG OR ITS COMPONENTS.
RENAL IMPAIRMENT: REVLIMID (LENALIDOMIDE) IS SUBSTANTIALLY EXCRETED BY THE
KIDNEY, SO THE RISK OF TOXIC REACTIONS MAY BE GREATER IN PATIENTS WITH IMPAIRED
RENAL FUNCTION. BECAUSE ELDERLY PATIENTS ARE MORE LIKELY TO HAVE DECREASED RENAL
FUNCTION, CARE SHOULD BE TAKEN IN DOSE SELECTION, AND IT WOULD BE PRUDENT TO
MONITOR RENAL FUNCTION.
NURSING MOTHERS: IT IS NOT KNOWN WHETHER REVLIMID (LENALIDOMIDE) IS EXCRETED IN
HUMAN MILK. BECAUSE OF THE POTENTIAL FOR ADVERSE REACTIONS IN NURSING INFANTS, A
DECISION SHOULD BE MADE WHETHER TO DISCONTINUE NURSING OR THE DRUG, TAKING INTO
ACCOUNT THE IMPORTANCE OF THE DRUG TO THE MOTHER.
OTHER ADVERSE EVENTS: MULTIPLE MYELOMA (REVLIMID/DEXAMETHASONE) CONSTIPATION
(39%), FATIGUE (38%), INSOMNIA (32%), MUSCLE CRAMP (30%), DIARRHEA (29%),
NEUTROPENIA (28%), ANEMIA (24%), ASTHENIA (23%), PYREXIA (23%), NAUSEA (22%),
HEADACHE ((21%), PERIPHEAL EDEMA (21%), DIZZINESS (21%), DYSPNEA (20%), TREMOR
(20%), DECREASED WEIGHT (18%), THROMBOCYTOPENIA (17%), RASH (16%), BACK PAIN
(15%), HYPERGLYCEMIA (15%), AND MUSCLE WEAKNESS (15%).
DELETION 5Q MDS (REVLIMID): DIARRHEA (49%), PRURITUS (42%), RASH (36%), FATIGUE
(31%), CONSTIPATION (24%), NAUSEA (24%), NASOPHARYNGITIS (23%), ARTHRALGIA
(22%), PYREXIA (21%), BACK PAIN (21%), PERIPHERAL EDEMA (20%), COUGH (20%),
DIZZINESS (20%), HEADACHE (20%), MUSCLE CRAMP (18%), DYSPNEA (17%), AND
PHARYNGITIS (16%).
ABOUT REVLIMID(R)
REVLIMID is a member of a proprietary group of novel immunomodulatory agents.
Celgene continues to evaluate REVLIMID in a broad range of hematological and
oncological conditions. The IMiDs(R) pipeline, including REVLIMID, 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.
REVLIMID is indicated for use as a treatment in combination with dexamethasone
for previously treated multiple myeloma. REVLIMID is also indicated 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 REVASSIST(SM)
FOR FURTHER INFORMATION ABOUT REVLIMID AND THE RevAssist PROGRAM, YOU MAY GO TO
THE INTERNET AT www.REVLIMID.com OR BY CALLING THE MANUFACTURER'S TOLL FREE
NUMBER 1-888-4CELGENE. RevAssist(SM) is a proprietary risk-management
restrictive distribution program, tailored specifically for REVLIMID patients,
to prevent the potential for human birth defects and ensure prompt and
convenient access to REVLIMID.
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 immuno-globulin 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.
In the year 2005, there were approximately 200,000 people worldwide suffering
from multiple myeloma. An estimated 74,000 new cases of multiple myeloma are
expected in 2006. The estimated number of deaths from multiple myeloma expected
in 2006 is approximately 60,000 worldwide. Average survival time for a patient
diagnosed with multiple myeloma is about three to four years.
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 mean 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, 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.
WEBCAST
Celgene will host a conference call on June 30, 2006 at 8:30 a.m. EDT to discuss
the FDA approval of REVLIMID(R). The conference call will be available by
webcast at www.celgene.com. An audio replay of the call will be available from
noon EDT June 30, 2006 until midnight EDT July 10, 2006. To access the replay,
dial 1-800-642-1687 and enter Reservation Number 2521167.
ABOUT CELGENE
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. RevAssist(SM) is a
service mark 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.
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