REVLIMID®
Offers "Transforming Potential" in
Hematological Cancers
~ Being evaluated in more than 30 blood cancers and
Global Market Opportunity
solid tumors ~
REVLIMID® is the first of Celgene's new class of cancer drugs
300*
called IMiDS®. These immuno-modulatory agents, taken orally as
capsules, have unique multiple mechanisms of action that involve
250
the micro-environment of the cancer cell, not just the malignant
cell itself. REVLIMID modifies cytokines and other growth
Multiple
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factors, it blocks the growth of new blood vessels that support
Myelomas
tumors, and it amplifies the body's natural immune response
against cancer cells.
150
Pharmacogenomics
100
REVLIMID also generates an additional cytogenetic response in
a subset of patients with a pre-leukemia called MDS. When
50
patients with a chromosome defect linked to MDS called the 5Q
deletion were treated with REVLIMID, in 83% of them the chro-
mosome defect disappeared. [List, et al. see next page]
USA
Total
Japan Rest of Total
EU
World
REVLIMID's unique mechanism and clinical findings to date
300*
support the potential of this new class of drugs.
Emerging Regimen for Multiple Myeloma
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Myelodysplastic
Before current treatments, patients diagnosed with multiple
200
Syndromes
myeloma lived an average of 33 months. Today lives are being
saved, extended and enhanced. As patients live longer there is a
150
growing need for more treatment options. REVLIMID along with
THALOMID and a deep pipeline of Celgene's IMiDs, are being
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tested alone, in combination, and in combination with other new
treatment regimens to help fill this need.
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MARCH 2005: Interim analysis of REVLIMID pivotal Phase III
trials in relapsed or refactory multiple myeloma patients exceeds
pre-established efficacy endpoints. Independent Data Monitoring
USA
Total
Japan Rest of Total
EU
World
Committee recommends moving all patients enrolled out of the
placebo arm and into the REVLIMID arm of the studies.
Prevalence: 2005 2010
* Patients in 1,000's
REVLIMID Anticipated Near-term Milestones
Date
Indication
Event
1Q:05
MDS/5q-
Completion of rolling NDA
"Multiple myeloma was an illness
2Q:05
MM/MDS & 5q-
Results presented at ASCO
with an `abysmal' prognosis.
1H:05
MDS & MDS/5q-
Initiate Phase III trials in Europe
With advances such as this
2H:05
MDS
Approval and launch
novel biotherapy, it is becoming
3Q:05
MM
sNDA filing
in my view a chronic illness in a
majority of patients."
Paul Richardson, M.D.
Dana Farber Cancer Institute

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MDS Study
Myelodysplastic syndromes (MDS) are a group of hematologic, pre-leukemic
malignancies that affect approximately 300,000 people worldwide.
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 MDS classifications. The total number of cases is expected to grow as the population ages. MDS
patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop
life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting
the cause of the condition rather than simply managing its symptoms.
"[REVLIMID] is the biggest thing we have ever had for this disease... It actually
changes the bone marrow itself and makes it work effectively, like a normal
bone marrow... In 20 years of dealing with patients with myelodysplasia, we
have never had anything with this magnitude of benefit for individuals that can
cause a remission, particularly with just a pill."
Alan List, M.D., Moffitt Cancer Center, quoted in
Medical Breakthroughs, Cardiovascular Health Channel
In February 2005, the New England Journal of
Centers of Excellence See Value in Studying
Medicine published an important study
REVLIMID as an Emerging Oncology Regimen
validating Celgene's expectations for
In a Phase II trial, led by Vincent Rajkumar, M.D. at
REVLIMID. Dr. Alan List, leader of the
the Mayo Clinic, 25 of 30 patients using the
Hematologic Malignancies Program at the H.
combination of REVLIMID plus dexamethesone
Lee Moffitt Cancer Center & Research
achieved an objective response yielding a
Institute in Florida, conducted a Phase I/II trial
response rate of 83% at that point in time.
that demonstrated REVLIMID's promise as an
Mohammad Hussein, M.D., Director of the
innovative way of treating patients with MDS.
Cleveland Clinic Cancer Center, reported on a
Administered orally as a capsule, REVLIMID
Phase II study of REVLIMID as a new therapeutic
has shown the ability to simultaneously block
approach for patients with relapsed/refractory
the growth of new blood vessels that nourish
multiple myeloma, showing a clinical benefit
tumors and stimulate the immune system to
based on a response rate of more than 66%.
fight cancer cells.
The Southwest Oncology Group (SWOG)
initiated a Phase III randomized, double blind,
Regulatory Strategy
placebo-controlled trial comparing the
combination of REVLIMID plus dexamethasone
REVLIMID has received both "Orphan Drug
with dexamethasone alone in patients with newly
Status" and "Fast Track" designation from the
diagnosed multiple myeloma.
Food and Drug Administration (FDA) based on
The Eastern Cooperative Oncology Group
unmet medical needs both in MM and MDS/5q
(ECOG) initiated a 3-armed randomized Phase III
deletion patients. Celgene will file an initial New
study of REVLIMID plus dexamethasone versus
Drug Application with the FDA [in the first
REVLIMID plus low-dose dexamethasone in
quarter of 2005], for the use of REVLIMID in a
multiple myeloma with thalidomide plus
dexamethasone salvage therapy for
sub-group of MDS patients with the 5q deletion
non-responders.
chromosomal abnormality. If approved,
REVLIMID's use in treating this debilitating form
The Cancer and Leukemia Group B (CALGB)
of blood cancer may have a positive effect on
initiated a Phase III randomized, double blind,
the lives of tens of thousands of patients around
placebo-controlled study of maintenance therapy
with REVLIMID or placebo following autologus
the world and on the company itself.
stem cell transplantation for multiple myeloma.
Celgene Corporation · 86 Morris Ave. · Summit, New Jersey 07901 · 908.673.9000 · www.celgene.com

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