Exhibit 99.1
Contact: Robert J. Hugin Brian P. Gill
Senior VP and CFO Director PR/IR
Celgene Corporation Celgene Corporation
(908) 673-9102 (908) 673-9530
FDA GRANTS REVLIMID(R) NDA APPROVAL
SUMMIT, NJ (DECEMBER 27, 2005) - Celgene Corporation (NASDAQ: CELG) announced
that the U.S. Food and Drug Administration (FDA) granted approval of REVLIMID
(lenalidomide) which is indicated 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 will be available through
a REVLIMID Education and Prescribing Safety Program, called RevAssist(sm) via
contracted pharmacies.
"The clinical data from a Phase II trial of 148 patients demonstrated that
Revlimid can reduce or even eliminate the need for transfusions in many patients
with del 5q MDS," said Dr. Alan List, Professor of Oncology and Medicine, and
Chief Division of Hematologic Malignancies Hematologic Malignancies at H. Lee
Moffitt Cancer Center, Tampa, Florida, and the study's lead investigator. "I am
extremely pleased with the FDA's action today."
The safety profile for REVLIMID has shown that neutropenia and/or
thrombocytopenia were the most common adverse event (AE) and that patients may
require a dose adjustment. Other observed and common AE's include diarrhea,
pruritis, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia,
pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp,
dyspnea, and pharyngitis.
"Being able to use an oral therapy such as REVLIMID to treat del 5q MDS could
reduce or even eliminate the need for red blood cell transfusions in MDS
patients," said Dr. John Bennett, Professor of Oncology in Medicine, Pathology,
and Laboratory Medicine, University of Rochester.
"The FDA approval of REVLIMID offers a new therapeutic option to this particular
group of patients with myelodysplastic syndromes," said Graham Burton, M.D.,
SVP, Regulatory Affairs and Pharmacovigilance for Celgene.
The timing of this approval will result in most initial shipments of REVLIMID to
be distributed in early 2006. This later than anticipated approval has also
resulted in an increase in pre-launch expenses of approximately $5 million, with
2005 full-year adjusted earnings per share now expected to be approximately
$0.36-$0.38 per diluted share.
SAFETY NOTICE:
REVLIMID(R) (lenalidomide) Capsules 5 mg & 10 mg
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WARNING: 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
LENALIDOMIDE. BECAUSE OF THIS POTENTIAL TOXICITY AND TO AVOID FETAL EXPOSURE TO
REVLIMID(R) (LENALIDOMIDE), IT 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 ARE
ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, PATIENTS MUST AGREE
TO COMPLY WITH THE REQUIREMENTS OF THE REVASSIST(SM) PROGRAM TO RECEIVE DRUG.
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WARNING:
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HEMATOLOGICAL TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)
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LENALIDOMIDE IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND THROMBOCYTOPENIA.
PATIENTS SHOULD HAVE THEIR CBC CHECKED WEEKLY FOR THE FIRST 8 WEEKS OF
REVLIMID(R) (LENALIDOMIDE) TREATMENT AND AT LEAST MONTHLY THEREAFTER TO MONITOR
FOR CYTOPENIAS. MOST DELETION 5Q MDS PATIENTS STUDIED REQUIRED A DOSE ADJUSTMENT
FOR NEUTROPENIA AND THROMBOCYTOPENIA.
WARNING: DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
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REVLIMID(R) (LENALIDOMIDE) HAS DEMONSTRATED SIGNIFICANT RISK OF DEEP VEIN
THROMBOSIS AND PULMONARY EMBOLISM IN SOME PATIENTS WITH CERTAIN MEDICAL
CONDITIONS.
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IMPORTANT SAFETY INFORMATION
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HYPERSENSITIVITY: REVLIMID(R) (lenalidomide) is contraindicated in any patients
who have demonstrated hypersensitivity to the drug or its components.
OTHER ADVERSE EVENTS: Other most frequently reported adverse events were
diarrhea, pruritis, rash, fatigue, constipation, nausea, nasopharyngitis,
arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache,
muscle cramp, dyspnea, and pharyngitis. REVLIMID(R) (lenaliodomide) is
substantially excreted by the kidney, so the risk of toxic reactions may be
greater in patients with impaired renal function.
ABOUT REVLIMID(R)
REVLIMID is a member of a proprietary group of novel IMiDs(R), immunomodulatory
drugs. Celgene continues to evaluate treatments with REVLIMID for a broad range
of hematology and oncology conditions. The IMiD 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.
ABOUT REVASSIST(SM)
FOR FURTHER INFORMATION ABOUT REVLIMID(R) AND THE RevAssist(SM) 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 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 percent 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.
The management team of Celgene will host a conference call at 9:00 a.m. EST,
December 28, 2005, to discuss the announcement of the FDA approval of
REVLIMID(R) and next steps to commercialization. The conference call will be
available by web cast at www.celgene.com. An audio replay of the call will be
available for two weeks starting from 4 p.m. EDT, December 28, 2005. To access
the replay, please dial 1-800-642-1687 (international dial-in 706-645-9291) and
enter Reservation Number 3896569.
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
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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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