Asia PR News

SUMMIT, N.J., Dec. 28 /PRNewswire-AsiaNet/ –

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

WARNING: POTENTIAL FOR HUMAN BIRTH DEFECTS.
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.

WARNING:

HEMATOLOGICAL TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)
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
REVLIMID(R) (LENALIDOMIDE) HAS DEMONSTRATED SIGNIFICANT RISK OF DEEP VEIN
THROMBOSIS AND PULMONARY EMBOLISM IN SOME PATIENTS WITH CERTAIN MEDICAL
CONDITIONS.

IMPORTANT SAFETY INFORMATION

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 http://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 announcement of the FDA approval of
REVLIMID(R) and next steps to commercialization. The conference call will be
available by web cast at http://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 http://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.

SOURCE Celgene Corporation

/CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian
P. Gill, Director PR and IR, +1-908-673-9530, both of Celgene Corporation/

/Web site: http://www.celgene.com/
http://www.REVLIMID.com/