Snda

REVLIMID® IN COMBINATION WITH DEXAMETHASONE sNDA
GRANTED APPROVAL BY FDA FOR TREATMENT OF MULTIPLE
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:
WARNINGS:
1. 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 REVLIMID® (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
“RevAssistSM”. 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 RevAssistSM PROGRAM.
2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
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.
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 THROMBOEMBOLISM. 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 RevAssistSM 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® (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®
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® 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 RevAssistSM
FOR FURTHER INFORMATION ABOUT REVLIMID AND THE RevAssist PROGRAM,
YOU MAY GO TO THE INTER OR BY CALLING THE
MANUFACTURER’S TOLL FREE NUMBER 1-888-4CELGENE. RevAssistSM 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®. The conference call will be available by webcast at
udio 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® is a registered trademark of Celgene Corporation. RevAssistSM 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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