Myelofibrosis

ATLANTA, Dec. 13 /PRNewswire-FirstCall/ -- Celgene Corporation announced that clinical data from a REVLIMID (lenalidomide) study in myelofibrosis (MF) were reported at an oral presentation during the 47th American Society of Hematology (ASH) Meeting in Atlanta, GA. The Phase II study evaluated previously treated patients with myelofibrosis, a rare blood disorder that can be fatal if untreated. To date, there are no drugs approved for the treatment of this disease.

At ASH, lead investigator Jorge Cortez, MD, of the University of Texas, M.D. Anderson Cancer Center, Houston, Texas, reported clinical findings on a Phase II study that enrolled forty-one patients with a median age of 65 (range, 42 to 83) who received REVLIMID at 10 mg/day orally (5 mg daily for patients with a platelet count less than 100,000 at the start of the study). Fifty-nine percent of evaluable patients exhibited a response to treatment and five previously transfusion-dependent patients no longer required transfusions. Patients with a known hypersensitivity to thalidomide were excluded.

"Myelofibrosis shares a common physiology with a number of other blood disorders," said Jerome B. Zeldis, M.D. Ph.D., Chief Medical Officer of Celgene Corporation. "These encouraging results will lead to further investigations into REVLIMID's potential as a treatment for these other conditions."

About the Trial

The Phase II study enrolled forty-one patients with myelofibrosis (primary or associated with myeloproliferative disorders) with a platelet count of at least 30x10(9)/L. Patients may have received prior therapies, but were excluded if they had known hypersensitivity to thalidomide. Thirty-six patients (88%) had received prior therapy for MF, including thirteen thalidomide patients (32%), thirteen hydroxyurea patients (32%), eleven interferon patients (27%), ten anagrelide patients (24%), and six erythropoietin patients (15%). Thirty-two patients were evaluable for response or toxicity. Responses were observed in nineteen patients (46%), including complete response (CR) achieved in three patients defined by normalization of Hgb and WBC, respectively. Partial response (PR) was achieved in five patients as a result of improvement in platelets and Hgb, +/- spleen, and hematologic improvement was observed in eleven patients based on improvement in platelets, spleen, WBC and BM blasts. Five of thirteen transfusion- dependent patients became transfusion independent. The median time to response was six weeks (range, 1 to 22). Responses were sustained for a median of thirty-one weeks (range, 1 to 40 weeks).

Therapy was well tolerated and side-effects clinically manageable, with the more common toxicities being rash in sixteen patients (39%), pruritus in nine patients (22%), thrombocytopenia in eleven patients (29%), fatigue in three patients (7%), and neutropenias in thirteen patients (32%). Eight patients (20%) have required dose reduction and four discontinued therapy because of toxicity.

About REVLIMID(R)

REVLIMID is a member of a group of proprietary novel compounds, IMiDs(R), which are being evaluated by Celgene as a treatment for a broad range of hematology and oncology conditions, including; multiple myeloma, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. 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(R) is not approved by the FDA or any other regulatory agencies as a treatment for any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Myelofibrosis

Myelofibrosis (also called agnogenic myeloid metaplasia) is a myeloproliferative disorder in which the bone marrow is initially over-active but then develops scar tissue (fibrosis). The term idiopathic means without known cause and differentiates this form of myelofibrosis from secondary myelofibrosis that may complicate other bone marrow diseases. Normal bone marrow has a very fine network of fibers supporting the blood forming tissues. In myelofibrosis this network is coarsened and thickened so that normal blood cell production is progressively reduced. As a result blood cell production begins to take place in the liver and spleen that become enlarged. These are both tissues which produce blood cells in the embryo but lose this function before birth. The production of blood cells in the liver and spleen is less efficient and so patients frequently develop anemia.

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 http://www.celgene.com/.

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.

CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian P. Gill, Director PR/IR, +1-908-673-9530, both for Celgene Corporation

Web site: http://www.celgene.com/

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