Two Major Phase III Studies Report Oral Revlimid (Lenalidomide) Plus Dexamethasone Shows Increased Overall Survival Advantage to Dexamethasone Plus Placebo in Previously Treated Multiple Myeloma Patients in The New England Journal of Medicine

BOUDRY, Switzerland--(BUSINESS WIRE)--Nov. 21, 2007--The New England Journal of Medicine today published updated clinical data from two Celgene Corporation (NASDAQ: CELG)-sponsored multi-centered, randomized, double-blind, placebo-controlled Phase III pivotal studies evaluating lenalidomide plus dexamethasone in previously treated multiple myeloma patients.

The updated clinical data from the pivotal International Phase III trial reported median time to disease progression in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo(p less than 0.0001). In the North American Phase III trial (MM-009) the updated clinical data reported overall survival and median time to disease progression in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo(p less than 0.0001).

The data were published in two separate articles by lead authors Meletios Dimopoulos, M.D., Associate Professor, Department of Clinical Therapeutics at "Alexandra" Hospital, Athens, Greece and Donna Weber, M.D., Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center, respectively.

Data reported in the International Phase III special protocol assessment trial (MM-010) included:

    --  The median time-to-disease progression (TTP) with lenalidomide
        plus dexamethasone was 11.3 months, compared with 4.7 months
        for dexamethasone plus placebo (p less than 0.0001). This
        constituted the longest TTP seen to date in previously treated
        multiple myeloma patients in phase III trials.

    --  Overall response rate with lenalidomide plus dexamethasone was
        60.2 percent, compared with 24 percent for dexamethasone plus
        placebo (p less than 0.001). These randomized Phase III trials
        have produced the highest response rate to date of any Phase
        III trial in previously treated patients with multiple
        myeloma.

    --  Complete or near-complete response (CR/nCR) rate with
        lenalidomide plus dexamethasone was 24.4 percent, compared
        with 5.1 percent for dexamethasone plus placebo (p less than
        0.001)

    --  The most common side effects observed in this trial with the
        combination of lenalidomide and dexamethasone were
        constipation, muscle cramps, nausea, tremor, dizziness and
        neutropenia

    --  Of note, the median overall survival (OS) with lenalidomide
        plus dexamethasone had not yet been reached, compared with
        20.6 months for dexamethasone plus placebo (p=0.03). In an
        updated presentation at the International Myeloma Workshop in
        June, pooled overall survival for patients in the North
        American trial MM-009 and International trial MM-010 with
        lenalidomide plus dexamethasone was 35 months. The longest
        median survival reported in phase III trials in previously
        treated MM patients.

In addition, patients in the two phase III trials showed the greatest improvement to date in TTP and deepest response rates if used earlier on in the treatment. Finally, patients in the trial showed the greatest duration of response at more than 15 months.

"The international study evaluating lenalidomide plus dexamethasone for previously treated multiple myeloma patients continued to demonstrate the effectiveness of this therapy through a significantly improved time to disease progression, high response rates and duration of response when compared to dexamethasone plus placebo," said Dr. Dimopoulos, the senior author on the International study. "The fact that the North American study data show similar results could be viewed as additional support for this conclusion."

    About the International and North American Phase III SPA Trials
Clinical data from the Phase III SPA trials will continue to be accumulated and updated, through patient follow-up, on an ongoing basis. These trials were designed to investigate the effectiveness and safety of cyclic dosing of lenalidomide at 25mg combined with high-dose dexamethasone (HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. These trials enrolled 705 patients and are being conducted in 97 sites internationally. Lenalidomide and HDD are given in 28-day cycles: lenalidomide 25 mg once daily on days 1-21 every 28 days, and HDD 40 mg on days 1-4, 9-12 and 17-20 every 28 days. After four cycles the HDD schedule is reduced to 40 mg on days 1-4 every 28 days). The primary endpoint of the study is time-to- disease progression calculated as the time from randomization to the first documentation of progressive disease based on EBMT myeloma response criteria.

REVLIMID is currently approved in the United States by the U.S. Food and Drug Administration (FDA) for 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, and for multiple myeloma patients who have received at least one prior therapy. REVLIMID has obtained Orphan Drug designation in the EU, U.S., Switzerland and Australia for treatment of multiple myeloma, MDS, and CLL.

Within the EU, Iceland and Norway, and Switzerland, REVLIMID(R) (lenalidomide) is authorized for marketing and, in combination with dexamethasone, is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

About REVLIMID(R)

REVLIMID is an IMiDs(R) compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline 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 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 immunoglobulin 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.

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 Celgene International Sarl

Celgene International Sarl, located in Boudry, 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.

This release contains certain forward-looking statements which involve 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 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 those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports.


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    CONTACT: Celgene Corporation
             David Gryska, 908-673-9059
             Sr. Vice President and Chief Financial Officer
             or
             Brian P. Gill, 908-673-9530
             Vice President, Corporate Communications

    SOURCE: Celgene International Sarl

 

Posted: November 2007

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