Celgene Corporation Receives Orphan Drug Designation for Revimid(TM)
`For Multiple Myeloma
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`PR Newswire
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`October 8, 2001, Monday
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`Copyright 2001 PR Newswire Association, Inc.
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`Section: FINANCIAL NEWS
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`Length: 749 words
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`Dateline: WARREN, N.J., Oct. 8
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`Body
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`Celgene Corporation (Nasdaq: CELG) announced today that REVIMID(TM), the Company's lead IMiD(TM)
`(Immunomodulatory Drug), has been granted orphan drug designation by the U.S. Food and Drug Administration
`(FDA) for multiple myeloma. Orphan drug status entitles Celgene to seven years of market exclusivity in multiple
`myeloma for REVIMID following FDA approval.
` The IMiDs are novel, small molecule, orally available analogs of thalidomide that are designed to be more potent
`and have demonstrated a better safety profile in clinical trials than the parent compound. Celgene's IMiDs have
`significantly greater immunological activity than thalidomide in in vitro studies. Data published in The Journal of
`Immunology demonstrated that IMiDs potently inhibit the inflammatory cytokines TNF-alpha and interleukin (IL)-1
`beta while stimulating the anti-inflammatory cytokine IL-10. IMiDs were also reported in Blood to enhance T-cell
`proliferation and IL-2 production. REVIMID and the IMiD pipeline are covered by a comprehensive intellectual
`property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter
`and use patents.
` REVIMID is being evaluated as a multiple myeloma therapy in two Phase I/II clinical trials at the Arkansas
`Cancer Research Center and the Dana-Farber Cancer Institute. In May, at the International Myeloma Workshop,
`Bart Barlogie, M.D., Ph.D. from the Arkansas Cancer Research Center and Ken Anderson, M.D. from the Dana-
`Farber Cancer Institute presented interim data from both trials. They reported that 60 percent of the late-stage
`multiple myeloma patients who had progressive disease were responding or had their disease stabilized on
`REVIMID therapy.
`Importantly, patients who experienced improvement continued to improve as therapy progressed. The investigators
`also reported that neither sedation nor constipation, common side effects of thalidomide treatment, was observed.
`Adverse effects noted were mild to moderate rash and reductions in white blood cell counts. Drs. Barlogie and
`Anderson are expected to present current interim data from the trials in December at the annual meeting of the
`American Society of Hematology.
`
` REVIMID also completed the initial phase of a clinical trial in metastatic melanoma, and based on the results, the
`trial is being expanded to an additional 60 patients who will be treated at greater than 100 mg/day. Further studies
`are planned for REVIMID in anti-inflammatory diseases, in addition to a recently initiated congestive heart failure
`trial.
`
` About Multiple Myeloma
` There are approximately 40,000 people in the United States living with multiple myeloma. It is the second most
`common blood cancer, with 14,000 new cases of multiple myeloma diagnosed each year in the United States.
`Incurable with conventional chemotherapy, multiple myeloma is a malignant cancer of the plasma cell, which is a
`type of white blood cell, found in many tissues of the body, but mainly in the bone marrow. As the cancer grows it
`destroys normal bone tissue, causing pain and crowding out normal cell production. There are nearly 11,200
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`ALVOGEN, Exh. 1014, p. 0001
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`Page 2 of 3
`Celgene Corporation Receives Orphan Drug Designation for Revimid(TM) For Multiple Myeloma
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`deaths expected during 2001, according to the Multiple Myeloma Research Foundation and the American Cancer
`Society.
`
` Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company
`engaged in the discovery, development and commercialization of small molecule drugs for the treatment of cancer
`and immunological diseases through gene regulation.
`
` 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.
`
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`SOURCE Celgene Corporation
`CONTACT: Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
`
`URL: http://www.prnewswire.com
`
`Classification
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`Language: ENGLISH
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`Subject: BLOOD DISORDERS (90%); PATENTS (90%); CANCER (90%); MEDICAL RESEARCH (90%);
`ONCOLOGY (90%); SCIENCE & TECHNOLOGY (90%); CLINICAL TRIALS (90%); DISEASES & DISORDERS
`(89%); INVESTIGATIONS (88%); DRUG & MEDICAL DEVICES APPROVAL (78%); CANCER DRUGS (78%);
`DRUG SAFETY (78%); INTELLECTUAL PROPERTY (78%); CHEMOTHERAPY & RADIATION (77%); US FDA
`REVIEW (77%); IMMUNOLOGY (75%); PATHOLOGY (75%); RESEARCH REPORTS (75%); RESEARCH
`INSTITUTES (74%); US FDA APPROVALS (72%); SKIN CANCER (68%); TALKS & MEETINGS (65%); HEART
`DISEASE (63%); CARDIOVASCULAR DISEASE (63%)
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`Company: CELGENE CORP (97%); DANA-FARBER CANCER INSTITUTE INC (91%); CELGENE CORP
`(97%); DANA-FARBER CANCER INSTITUTE INC (91%); Celgene Corporation FOOD & DRUG
`ADMINISTRATION (91%); FOOD & DRUG ADMINISTRATION (91%); DANA-FARBER CANCER INSTITUTE
`(82%); DANA-FARBER CANCER INSTITUTE (82%); Celgene Corporation
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`Organization: FOOD & DRUG ADMINISTRATION (91%); FOOD & DRUG ADMINISTRATION (91%); DANA-
`FARBER CANCER INSTITUTE (82%); DANA-FARBER CANCER INSTITUTE (82%)
`
`Ticker: CELG (NASDAQ) (97%); CELG (NASDAQ) (97%); CELG
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`Industry: PHARMACEUTICALS PRODUCT DEVELOPMENT (90%); ONCOLOGY (90%); IMMUNOLOGIC
`FACTORS (90%); PHARMACEUTICALS INDUSTRY (90%); CLINICAL TRIALS (90%); ORPHAN DRUGS (89%);
`ANTI-INFLAMMATORY AGENTS (89%); ACADEMIC MEDICAL CENTERS (89%); DRUG & MEDICAL DEVICES
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`ALVOGEN, Exh. 1014, p. 0002
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`Page 3 of 3
`Celgene Corporation Receives Orphan Drug Designation for Revimid(TM) For Multiple Myeloma
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`APPROVAL (78%); CANCER DRUGS (78%); DRUG SAFETY (78%); US FDA REVIEW (77%); IMMUNOLOGY
`(75%); PATHOLOGY (75%); US FDA APPROVALS (72%); BIOLOGICAL FACTORS (69%)
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`Geographic: UNITED STATES (91%)
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`Load-Date: October 9, 2001
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`End of Document
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`ALVOGEN, Exh. 1014, p. 0003
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