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Teva takes option to commercialize Gamida-Cell's Stem-Ex

StemEx is a stem-cell derived treatment for leukemia and lymphoma. Teva will invest up to $25 million.

Globes correspondent
16 Feb 05 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and Gamida-Cell Ltd. announced today that Teva has exercised the option to enter into a joint venture with Gamida-Cell Ltd. The two companies will develop and commercialize Gamida-Cell's StemEx for the treatment of leukemia and lymphoma.

As part of its investment in Gamida-Cell in 2003, Teva held an option to jointly complete the development and globally commercialize StemEx. Teva will invest under certain conditions up to $25 million in the joint venture.

Currently, only 15% of patients requiring bone marrow transplantation, who do not have genetically matched relatives, are able to find matching donors. StemEx, which is based on inventions made in the Hadassah hospital in Jerusalem, is cord blood highly enriched with stem cells.

According to Gamida-Cell, StemEx has the potential to fulfill a life saving unmet need for the majority of the patients who cannot find matching donors. This was shown by data from the recent Gamida-Cell Phase I/II study presented at the annual conference of the American Society for Hematology (December 2004).

Teva president and CEO Israel Makov said, "The investment and exercise of the option with Gamida-Cell are part of Teva's strategy to enter into the field of cell therapy. As part of this strategy Teva led the Israeli cell therapy consortium 'Genesis,' and in addition to Gamida-Cell, invested in Proneuron, an Israeli company developing cell-based therapies for complete spinal cord injury. Teva believes in the potential of cell therapy and is committed to bringing to the world market new therapies based on Israeli science."

Teva and Gamida plan to meet the Food and Drug Administration and other regulatory agencies in order to finalize the parameters for the pivotal study. The companies hope to initiate this study in the second half of 2005.

Gamida-Cell CEO Ehud Marom said, "It is our intention to begin the pivotal Phase II/III study of StemEx and secure fast track designation".

Gamida-Cell deals in the expansion of hematopoietic (blood) stem cell therapeutics in clinical development for cancer and autoimmune diseases, as well as future regenerative cell-based medicines including cardiac and pancreatic repair. Major shareholders are Elscint (Europe-Israel), Biomedical Investments, Denali Ventures, Teva, Auriga Ventures, Pamot and Comsor.

Published by Globes [online], Israel business news - www.globes.co.il - on Wednesday, February 16, 2005

REVLIMID(R) New Drug Application Submitted to FDA for Review

Clinical Data From Phase II Trial (MDS-003) in Patients With Myelodysplastic Syndromes With 5q Deletion Chromosomal Abnormality Submitted

SUMMIT, N.J., April 8 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that it has completed the rolling submission of its New Drug Application (NDA) for REVLIMID (lenalidomide), an investigational drug, to the Division of Oncology Drug Products at the U.S. Food and Drug Administration (FDA) for review. The Company's NDA is seeking approval to market REVLIMID as a treatment for transfusion-dependent patients with myelodysplastic syndromes (MDS) with a 5q deletion chromosomal abnormality.

MDS is a malignant disorder of blood cell production that affects approximately 300,000 people worldwide. The most common clinical manifestation associated with MDS is refractory anemia, and the multiple complications that stem from frequent blood transfusions. Celgene's lead IMiD(R) (Immunomodulatory drug), REVLIMID has received both orphan drug status and fast track designation from the U.S. Food and Drug Administration (FDA) and orphan drug status from the European Agency for the Evaluation of Medicinal Products for the treatment of MDS.

"Celgene appreciates and acknowledges the efforts of all those who made this filing possible, including: the more than 400 patients who participated in these MDS studies, and the international community of clinical investigators who have helped us get to this stage in the regulatory process." said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation.

About REVLIMID(R)

REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) 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) (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

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 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.

About 5q Deletion 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 to 30% 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

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 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 10K, 10Q and 8K reports.

CONTACT:
Robert J. Hugin
Senior VP and CFO
+1-908-673-9102

Brian P. Gill
Director PR-IR
Celgene Corporation
+1-908-673-9530

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