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`Contact: Robert J. Hugin
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`President and COO
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` Celgene Corporation
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` (908) 673-9102
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`Brian P. Gill
`Senior Director, PR/IR
`Celgene Corporation
`(908) 673-9530
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`REVLIMID® (Lenalidomide) CLINICAL RESULTS IN NON-HODGKINS
`LYMPHOMA PRESENTED AT THE 11th CONGRESS OF THE
`EUROPEAN HEMATOLOGY ASSOCIATION
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`Preliminary Phase II Data Demonstrated Response to REVLIMID in Patients with
`Aggressive Non-Hodgkin's Lymphoma
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`AMSTERDAM – (June 19, 2006) – Celgene International Sárl, a wholly owned
`subsidiary of Celgene Corporation, announced clinical data from a multi-center, single
`arm open label Phase II clinical study evaluating single agent lenalidomide in patients
`with relapsed and refractory aggressive Non-Hodgkins lymphoma (NHL) were presented
`at the 11th Congress of the European Hematology Association (EHA) in Amsterdam,
`Netherlands on Saturday, June 17, 2006.
`
`NHL is the most common form of blood cancer in the United States affecting more than
`360,000 people. Approximately 50 percent have aggressive NHL, while the other half
`have indolent or follicular lymphoma. According to the American Cancer Society, more
`than 56,000 men and women in the United States are diagnosed with NHL each year, and
`19,000 are expected to die from NHL in 2006.
`
`The data were presented at a poster session by Peter Wiernik, M.D., Director of Clinical
`Oncology at Our Lady of Mercy Medical Center, Bronx, New York. Preliminary results
`from Phase II study (NHL-002) with single agent therapy REVLIMID in patients with
`relapsed and refractory aggressive (NHL) were reported as follows:
`
` Twenty-five patients age 45-80 (median age 63), with relapsed and refractory
`aggressive NHL, and who had received a median of 2.5 prior treatments (range: 1-6
`prior treatments), were administered 25 mg of REVLIMID orally once daily for 21
`days in the treatment cycle.
`• Sixteen patients with aggressive NHL were evaluable for tumor assessment, of which
`there were 5 (31%) patients who experienced objective responses:
`(cid:131) 1 patient with diffuse large cell lymphoma achieved complete response
`(unconfirmed) with progression free survival of more than 180 days
`(cid:131) 1 patient with diffuse large cell lymphoma achieved partial response with
`progression free survival for 135 days
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` •
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`(cid:131) 1 patient with diffuse large cell lymphoma achieved partial response with
`progression free survival for 242 days
`(cid:131) 1 patient with follicular lymphoma achieved partial response with progression
`free survival for more than 55 days
`(cid:131) 1 patient with mantle cell lymphoma achieved partial response with
`progression free survival for more than 57 days
`
`
`About the Trial
`The Phase II multi-center, single arm, open label trial was designed to evaluate the
`therapeutic potential and safety of REVLIMID® oral monotherapy in 40 patients with
`relapsed refractory aggressive NHL following one or more prior treatment regimen with
`measurable disease. The median number of prior therapies was 2.5 (range: 1-6 prior
`treatments). Patients in the study received 25 mg of REVLIMID orally once daily for
`days 1-21 in a 28-day cycle and continued therapy for 52 weeks as tolerated or until
`disease progression.
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`As of April 28, 2006, 25 of the 40 patients were enrolled, 22 had received drug and 16
`patients were evaluable for response. Of the 16 evaluable patients, 1 patient achieved an
`unconfirmed complete response (CRu) and 4 patients achieved partial responses (PR) to
`Revlimid monotherapy. Four patients exhibited stable disease and 7 patients had disease
`progression after a median follow-up of 2 months (range 1-7 months). Of the 16 patients,
`8 had diffuse large cell lymphoma, 3 patients had mantle cell lymphoma, 2 patients had
`follicular lymphoma, 1 patient had transformed lymphoma, and 2 patients had aggressive
`lymphoma of unknown histology.
`
`Grade 3 and 4 adverse events occurred in 10 of 22 patients (45%). These were
`predominately hematological and Grade 3, with only 3 patients (14%) experiencing a
`Grade 4 adverse reaction.
`
`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).
`
`2. HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA).
`THIS DRUG
`IS ASSOCIATED WITH SIGNIFICANT NEUTROPENIA AND
`THROMBOCYTOPENIA IN PATIENTS WITH DEL 5q MDS. EIGHTY PERCENT OF
`PATIENTS HAD TO HAVE A DOSE DELAY/REDUCTION DURING THE MAJOR
`STUDY FOR THE DEL 5q MDS INDICATION. 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 SHOULD HAVE THEIR COMPLETE BLOOD
`COUNTS MONITORED WEEKLY FOR THE FIRST 8 WEEKS OF THERAPY AND AT
`LEAST MONTHLY THEREAFTER.
`PATIENTS MAY REQUIRE DOSE
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`INTERRUPTION AND/OR REDUCTION. PATIENTS MAY REQUIRE USE OF BLOOD
`PRODUCT SUPPORT AND/OR GROWTH FACTORS.
`(SEE DOSAGE AND
`ADMINISTRATION)
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`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.
`
`information about REVLIMID® (lenalidomide) on the Internet at
`You can get
`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 reported in ≥15% of del 5q MDS patients: 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 compounds,
`IMiDs®. Celgene continues to evaluate REVLIMID in 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.
`
`REVLIMID is approved by the FDA 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. REVLIMID is not approved by the FDA or any other regulatory agencies
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`as a treatment for any other indication and is currently being evaluated in clinical trials
`for efficacy and safety for future regulatory applications.
`
`About Non-Hodgkins Lymphoma
`Non-Hodgkin's lymphoma (NHL) is a cancer of B or T cells in the lymph system. NHL
`encompasses over 29 types of lymphoma and are characterized by the US National
`Cancer Institute as aggressive (fast growing) and indolent (slow growing). Aggressive
`lymphomas, also known as intermediate and high-grade lymphomas, tend to grow and
`spread quickly and cause severe symptoms. Indolent lymphomas, also referred to as low-
`grade lymphomas, tend to grow quite slowly and cause fewer symptoms.
`
`There are currently more than 360,000 people in the United States living with NHL.
`Approximately 50 percent have aggressive NHL, while the other half have indolent or
`follicular lymphoma. According to the American Cancer Society, more than 56,000 men
`and women in the United States are diagnosed with NHL each year, and 19,000 deaths
`are attributed to the disease annually.
`
`About Celgene International Sárl
`Celgene International Sárl, located in Neuchâtel, Switzerland, is a wholly owned
`subsidiary and international headquarters of Celgene Corporation. 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.
`
`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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