Positive Interim Results Presented at the VIIIth International Myeloma
`Workshop on Celgene Corporation's Lead IMiD(TM) (REVIMID(TM));
`Lead Investigators from Dana-Farber Cancer Institute and the Arkansas
`Cancer Research Center Reported on REVIMID's Activity and Safety Profile
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`PR Newswire
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`May 8, 2001, Tuesday
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`Copyright 2001 PR Newswire Association, Inc.
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`Section: FINANCIAL NEWS
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`Length: 1318 words
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`Dateline: BANFF, Alberta, May 8
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`Body
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`Celgene Corporation (Nasdaq: CELG) today announced that investigators from the Arkansas Cancer Research
`Center and Dana-Farber Cancer Institute presented preliminary results on REVIMID(TM), Celgene's lead
`Immunomodulatory Drug (IMiD(TM)) for the treatment of multiple myeloma. Bart Barlogie, M.D., Ph.D., Director of
`the Arkansas Cancer Research Center and Kenneth C. Anderson, M.D. and Paul G. Richardson, M.D. of Dana-
`Farber Cancer Institute and Harvard Medical School presented interim data at the VIIIth International Myeloma
`Workshop on Phase I/II trials studying REVIMID's potential safety and efficacy in multiple myeloma patients. More
`than sixty percent of these late stage patients who had progressive disease were responding or had their disease
`stabilized on the REVIMID therapy. Those patients who experienced improvement continued to improve as therapy
`progressed. The investigators also reported that no dose limiting toxicities were observed and as a result, a
`maximum tolerated dose has not yet been determined. Ongoing studies will observe the tolerability and therapeutic
`activity of escalating doses of REVIMID.
` "These encouraging results are the first major step in the validation of our IMiD class of drugs and reflect the
`exciting potential of this novel compound," said Sol J. Barer, Ph.D., President and Chief Operating Officer of
`Celgene Corporation. "We will now significantly accelerate our clinical and regulatory programs in multiple
`myeloma and other oncology indications."
` IMiDs are novel, small-molecule, orally available analogs of thalidomide that are designed to be more potent and
`potentially have a better safety profile than the parent compound.
`Celgene's IMiDs have significantly greater immunological activity in in vitro studies. IMiDs were reported in the
`November 1, 2000 issue of BLOOD to enhance T-cell proliferation and interleukin (IL)-2 production. In the same
`report, IMiDs were also shown to be potent inhibitors of inflammatory cytokines that include TNF-alpha and IL-1beta
`while stimulating the anti-inflammatory cytokine IL-10. IMiDs, including Celgene's current lead clinical candidate
`REVIMID, are covered by issued and pending patents in the U.S. and internationally.
`
` Dr. Bart Barlogie reported on the treatment of twelve refractory multiple myeloma patients in a four week, open-
`label safety trial. The study included eleven patients who have completed four weeks of REVIMID monotherapy
`treatment and one patient who had completed two weeks of therapy. Four patient cohorts, of three patients each,
`received a daily dose of 5 mg, 10 mg, 25 mg, and 50 mg of REVIMID, respectively. Patients were evaluated by
`reductions in levels of paraproteins, which are validated clinical markers associated with corresponding reduction in
`bone marrow plasmacystosis, recovery from anemia/thrombocytopenia and uninvolved immunoglobulins.
`
` To date, in all four dosing levels, patients tolerated the treatment well with no grade four toxicities observed.
`Adverse effects noted were mild to moderate rash not necessitating dose modification and reductions in the
`granulocyte count. Neither sedation nor constipation, common side effects of thalidomide treatment, were
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`Page 2 of 3
`Positive Interim Results Presented at the VIIIth International Myeloma Workshop on Celgene Corporation's
`Lead IMiD(TM) (REVIMID(TM));Lead Investigators from Dan....
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`observed. No peripheral neuropathy developed during therapy and those who had peripheral neuropathy at study
`entry did not have this symptom exacerbated during the course of the trial.
`
` Improved response was seen with higher dosages of REVIMID. During the first four weeks of therapy, four
`patients had a greater than 25 percent reduction of paraprotein levels including one patient experiencing a 75
`percent reduction in paraprotein levels. All three patients at the highest dose level (50 mg/day) were responding.
`Three patients had progressive disease.
`
` "The multiple myeloma patients in this trial were predominantly thalidomide-resistant or had poor cytogenetics,"
`said Dr. Barlogie. "Because this drug is so well tolerated, we plan to use higher levels to define the maximum
`tolerated dose."
`
` Results of the open-label safety trial conducted at Dana-Farber Cancer Institute were also presented by Dr.
`Kenneth C. Anderson and Dr. Paul G. Richardson. The study included patients with rapidly advancing refractory
`multiple myeloma, nine of whom had failed thalidomide and multiple other therapies and ten of whom had prior
`bone marrow transplants. Side effects in this study were consistent with those reported in the University of
`Arkansas study, which included rash and a decrease in white blood cell count. No sedation, constipation or
`exacerbation of peripheral neuropathy were observed. Treatment with REVIMID up to 25 mg per day was well
`tolerated, with seven of eleven evaluable patients demonstrating a response to the drug. Four patients had
`progressive disease. Of those who were responding to the drug, one patient experienced a greater than 50 percent
`reduction in paraprotein levels and five patients had between a 25 and 50 percent reduction in paraprotein levels.
`
` "These data lay a promising foundation for what may be a whole new approach to the treatment of multiple
`myeloma, with possible substantial improvements in outcomes and patient quality of life," said Dr. Anderson. "We
`anticipate a highly productive clinical trial program with REVIMID for multiple myeloma."
`
` About Multiple Myeloma
` There are approximately 40,000 people in the United States living with multiple myeloma and 14,400 new cases
`of multiple myeloma are diagnosed each year in the United States, making it the second most common blood
`cancer. Incurable with conventional chemotherapy, multiple myeloma is a malignant cancer of the plasma cells,
`which are a type of white blood cells, 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 blood cell production. There
`are nearly 11,200 deaths expected during 2001, according to the Multiple Myeloma Research Foundation.
` In addition to studies presented the VIIIth International Myeloma Workshop, Celgene is currently conducting
`Phase I/II studies of REVIMID in the United Kingdom in solid tumors, including malignant melanoma and pancreatic
`cancer. A congestive heart failure trial with REVIMID will commence this quarter in the United States.
`
` Celgene Corporation will host its first annual Analyst and Investor Day on June 7, 2001 in New York City where
`the progress of the IMiDs and the entire Celgene product pipeline will be more fully discussed. An invitation to this
`event can be requested by visiting Celgene's website at http://www.celgene.com.
` Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company
`engaged in the discovery, development and commercialization of small molecule drugs for cancer and
`immunological diseases.
`
` 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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`ALVOGEN, Exh. 1012, p. 0002
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`Page 3 of 3
`Positive Interim Results Presented at the VIIIth International Myeloma Workshop on Celgene Corporation's
`Lead IMiD(TM) (REVIMID(TM));Lead Investigators from Dan....
`
`SOURCE Celgene Corporation
`CONTACT: Robert J. Hugin, Senior Vice President & CFO of Celgene Corporation, 732-271-4102
`
`URL: http://www.prnewswire.com
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`Classification
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`Language: ENGLISH
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`Subject: CANCER (91%); BLOOD DISORDERS (90%); DISEASES & DISORDERS (90%); MEDICAL RESEARCH
`(90%); ONCOLOGY (90%); INVESTIGATIONS (90%); DRUG SAFETY (89%); SCIENCE & TECHNOLOGY (89%);
`RESEARCH INSTITUTES (78%); MEDICAL TREATMENTS & PROCEDURES (78%); NEW CHEMICALS (77%);
`ANEMIA (74%); PATENTS (72%); EXECUTIVES (71%); GRADUATE & PROFESSIONAL SCHOOLS (71%)
`
`Company: CELGENE CORP (97%); DANA-FARBER CANCER INSTITUTE INC (93%); CELGENE CORP
`(97%); DANA-FARBER CANCER INSTITUTE INC (93%); Celgene Corporation; Arkansas Cancer Research
`Center; Dana-Farber Cancer Institute DANA-FARBER CANCER INSTITUTE (94%); Arkansas Cancer Research
`Center; Dana-Farber Cancer Institute DANA-FARBER CANCER INSTITUTE (94%); Dana-Farber Cancer
`Institute DANA-FARBER CANCER INSTITUTE (94%); DANA-FARBER CANCER INSTITUTE (94%); Celgene
`Corporation; Arkansas Cancer Research Center; Dana-Farber Cancer Institute
`
`Organization: DANA-FARBER CANCER INSTITUTE (94%); DANA-FARBER CANCER INSTITUTE (94%)
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`Ticker: CELG (NASDAQ) (97%); CELG (NASDAQ) (97%); CELG
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`Industry: ONCOLOGY (90%); ACADEMIC MEDICAL CENTERS (90%); DRUG SAFETY (89%); IMMUNOLOGIC
`FACTORS (89%); ANTI-INFLAMMATORY AGENTS (78%); DRUG EFFICACY (77%); NEW CHEMICALS (77%);
`CARDIOVASCULAR DRUGS (73%); GRADUATE & PROFESSIONAL SCHOOLS (71%)
`
`Person: SOL J BARER (59%)
`
`Geographic: UNITED STATES (77%)
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`Load-Date: May 9, 2001
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`End of Document
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`ALVOGEN, Exh. 1012, p. 0003
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