Celgene Corporation
Dec 11, 2011
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Results from a Comparative Analysis Show REVLIMID® Demonstrates Statistically Significant Reduction in Risk of Death and No Evidence of Increased Risk of Progression to AML in Patients with Deletion 5q MDS Compared with Best Supportive Care

The Study Reported Median Overall Survival of 5.2 Years for Patients Treated with REVLIMID (Lenalidomide) Compared with 3.8 Years for Untreated Patients

BOUDRY, Switzerland--(BUSINESS WIRE)--Dec. 11, 2011-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced results from a retrospective analysis to assess the risk of acute myeloid leukemia (AML) progression and death in REVLIMID (lenalidomide)-treated versus untreated patients with red blood cell (RBC) transfusion-dependent patients with IPSS Low or Int-1 risk myelodysplastic syndromes (MDS) with deletion 5q chromosome (with or without additional cytogenetic abnormalities). These results were presented during the 53rd Annual Meeting of the American Society of Hematology in San Diego, CA.

In this retrospective analysis, 295 lenalidomide-treated patients from two Celgene-sponsored multicenter trials, MDS-003 and MDS-004, were compared with 125 untreated patients from an international multi-center MDS Registry with similar baseline characteristics who had received best supportive care only, including erythropoiesis-stimulating agents (ESAs) in some patients. Baseline characteristics of lenalidomide-treated patients were similar to registry patients, except for a higher RBC transfusion burden among lenalidomide-treated patients (median [range] units/8 weeks: 6 [1-25] vs. 2 [1-10]).

The lenalidomide-treated patients benefited from a reduction in risk of death, while no risk of progression to AML was observed, despite a higher transfusion burden at baseline compared with patients from the MDS registry who had not received lenalidomide.

The two- and five-year cumulative overall survival (OS) probabilities were 90% and 54% for patients treated with lenalidomide compared with 74% and 41% for patients not treated with lenalidomide. In addition, the two- and five-year cumulative AML incidences were 7% and 23% for patients treated with lenalidomide compared with 12% and 20% for patients not treated with lenalidomide. The median OS was 5.2 years for patients treated with lenalidomide compared with 3.8 years for patients not treated with lenalidomide, and the median time to AML progression had not been reached for either cohort.

Significant baseline factors associated with an increased risk of AML progression included: complex cytogenetics (greater than or equal to 2, p=0.002); 5–10% bone marrow blasts (p=0.016); and higher transfusion burden (10% increase in risk per unit at baseline, p=0.029). Furthermore, higher hemoglobin (Hgb) levels at baseline were associated with a reduced risk of AML progression (p=0.054). Factors that reduced the risk of death included treatment with lenalidomide (p=0.012); higher baseline Hgb levels (p=0.028); higher baseline platelet counts (p=0.035), and female gender (p=0.002). The risk of death increased as a result of baseline transfusion burden (p=0.037) and age (p<0.001).

About REVLIMID®

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand, and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

Since 1998, Celgene continues to be a pioneer in creating environments in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S.T.E.P.S.®, RevAssist® and RevMate®, which form the foundation of our commitment to patient safety.

U.S. Regulatory Information for REVLIMID

REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy.

REVLIMID ® (lenalidomide) is indicated for 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.

Important Safety Information

WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or death to a developing baby. In women of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Women of childbearing potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid fetal exposure to lenalidomide, REVLIMID is only available in the United States under a restricted distribution program called “RevAssist®.”

Information about the RevAssist program is available at www.REVLIMID.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

HEMATOLOGIC TOXICITY (NEUTROPENIA AND THROMBOCYTOPENIA)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS 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 del 5q MDS 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)

DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM

EXTEND BLACK BOX AROUND THIS PARAGRAPHREVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with MM who were treated with REVLIMID and dexamethasone 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 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.

CONTRAINDICATIONS:

Pregnancy Category X:

Allergic Reactions:

WARNINGS AND PRECAUTIONS:

Fetal Risk:

Reproductive Risk and Special Prescribing Requirements (RevAssist Program):

Hematologic Toxicity—Multiple Myeloma:

Deep Vein Thrombosis:

Allergic Reactions:

Tumour Lysis Syndrome:

Tumour Flare Reaction:

DRUG INTERACTIONS:

USE IN SPECIAL POPULATIONS:

Nursing Mothers:

Geriatric Use:

Renal Impairment:

ADVERSE REACTIONS:

Multiple Myeloma

Myelodysplastic Syndromes

DOSAGE AND ADMINISTRATION:

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

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. MDS patients must often rely on blood transfusions to manage symptoms of anaemia 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 Acute Myeloid Leukaemia

Acute Myeloid Leukaemia (AML) is a cancer of myeloid blood cells that often transforms from MDS upon disease progression. AML is the proliferation of abnormal cells that accumulate in the bone marrow and interfere with all types of normal blood cell production (multi-lineage dysplasia). AML has traditionally been treated with high intensity chemotherapy, which is poorly tolerated by the majority of the patients who are afflicted - the elderly. Many of these patients may go untreated and because they are ineligible for curative therapy, life expectancy is short and often measured in weeks to months.

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.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of 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.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Source: Celgene International Sàrl

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