Investigators Report Revimid(TM) Demonstrates Anti-Tumor Activity in
`Phase I/II Clinical Trials In Multiple Myeloma;
`Celgene Corporation Will Significantly Expand Clinical Development of
`REVIMID
`PR Newswire
`December 11, 2001, Tuesday
`
`Copyright 2001 PR Newswire Association, Inc.
`Section: FINANCIAL NEWS
`Length: 1053 words
`Dateline: ORLANDO, Fla., Dec. 11
`Body
`
`Celgene Corporation (Nasdaq: CELG) -- Kenneth Anderson, M.D. from the Dana-Farber Cancer Institute at Harvard
`University and Bart Barlogie, M.D., Ph.D. from the Arkansas Cancer Research Center and their colleagues
`presented new clinical data at the 43rd annual meeting of the American Society of Hematology from two Phase I/II
`trials of REVIMID(TM) in refractory and relapsed multiple myeloma. The investigators reported that REVIMID
`demonstrated significant anti-tumor activity and was generally well tolerated in patients.
`
` "These encouraging results continue to validate our pipeline of IMiD compounds and based on these data we will
`substantially expand the clinical development of REVIMID," said Sol J. Barer, Ph.D., President and Chief Operating
`Officer of Celgene Corporation. "Following discussions with the FDA, we plan to initiate two pivotal clinical
`programs for REVIMID in multiple myeloma and metastatic melanoma with over 1,000 patients in each program.
`Each program will be comprised of three pivotal trials, in both refractory and newly diagnosed stages of each
`disease."
`
` Paul G. Richardson, M.D. presented data from an open-label safety clinical trial conducted at Dana-Farber. The
`study included twenty-four evaluable patients with rapidly advancing refractory multiple myeloma, sixteen of whom
`had failed thalidomide and all of whom had failed at least two prior regimens. Patients were treated with one of four
`doses of REVIMID: 5 mg/day, 10 mg/day, 25 mg/day or 50 mg/day. After 28 days, if tolerated and without disease
`progression, patients were permitted to continue on therapy.
`Nineteen patients (79 percent) achieved stable disease or better and 63 percent of patients experienced a greater
`than 25 percent reduction in paraprotein. No dose limiting toxicities were observed within twenty-eight days at any
`dose level. In the extension phase of the trial, dose reduction was required for grade 3 thrombocytopenia and
`grade 3/4 neutropenia. Somnolence, constipation and neuropathy, common side effects of thalidomide, were not
`observed.
` "REVIMID demonstrated anti-tumor activity in these very difficult to treat patients," said Dr. Richardson. "The
`therapy was generally well tolerated and may represent a new approach to the treatment of multiple myeloma."
` Maurizio Zangari, M.D. from the Arkansas Cancer Research Center reported on the treatment of fifteen refractory
`multiple myeloma patients who participated in two clinical trials: a four week, open-label safety trial and an
`extension trial. In the first trial, patients received a daily dose of 5 mg, 10 mg, 25 mg, or 50 mg of REVIMID. If
`tolerated and without disease progression, patients entered an extension trial in which the dose could be
`adjusted. Eight patients (53 percent) experienced a greater than 25 percent reduction in paraprotein and one
`patient achieved a complete response. In the extension phase of the trial at higher doses, clinically significant, but
`manageable, reductions in both the granulocyte and platelet counts were observed.
` "We are looking forward to advancing REVIMID based on its clinical activity and tolerability," said Dr. Zangari.
`
`DR. REDDY’S LABS., INC. EX. 1012 PAGE 1
`
`

`

`
`
`Investigators Report Revimid(TM) Demonstrates Anti-Tumor Activity in Phase I/II Clinical Trials In Multiple
`Myeloma;Celgene Corporation Will Significantly Expan....
`
` REVIMID has also completed the initial phase of a clinical trial in metastatic melanoma, and based on the results,
`the trial is being expanded with an additional 60 patients. Further studies are planned for REVIMID in anti-
`inflammatory diseases, in addition to a recently initiated congestive heart failure pilot trial.
` 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,
`pharmaceutical composition and use patents.
`
` 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 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.
`
` MAKE YOUR OPINION COUNT - Click Here
`
` http://tbutton.prnewswire.com/prn/11690X51697372
`SOURCE Celgene Corporation
`CONTACT: Robert J. Hugin, Senior Vice President and CFO of Celgene Corporation, +1-732-271-4102
`URL: http://www.prnewswire.com
`Classification
`
`Language: ENGLISH
`
`Subject: BLOOD DISORDERS (90%); CANCER (90%); DISEASES & DISORDERS (90%); MEDICAL RESEARCH
`(90%); INVESTIGATIONS (90%); ONCOLOGY (89%); CLINICAL TRIALS (89%); RESEARCH INSTITUTES (78%);
`TALKS & MEETINGS (77%); NEUROLOGICAL DISORDERS & INJURIES (73%); SKIN CANCER (73%);
`EXECUTIVES (69%)
`
`Company: CELGENE CORP
`(92%); CELGENE
`INC
`INSTITUTE
` DANA-FARBER CANCER
`(97%);
`CORP (97%);
` DANA-FARBER CANCER
`INSTITUTE
`INC (92%);
` Celgene Corporation
` HARVARD
`UNIVERSITY
`
`(84%);
` DANA-FARBER CANCER
`INSTITUTE
`
`(84%);
` DANA-FARBER CANCER
`
`DR. REDDY’S LABS., INC. EX. 1012 PAGE 2
`
`

`

`
`
`Investigators Report Revimid(TM) Demonstrates Anti-Tumor Activity in Phase I/II Clinical Trials In Multiple
`Myeloma;Celgene Corporation Will Significantly Expan....
`
`INSTITUTE (84%); HARVARD UNIVERSITY (84%); FOOD & DRUG ADMINISTRATION (56%); FOOD &
`DRUG ADMINISTRATION (56%); Celgene Corporation
`
`Organization: HARVARD UNIVERSITY (84%); DANA-FARBER CANCER INSTITUTE (84%); DANA-FARBER
`CANCER
`INSTITUTE
`(84%);
` HARVARD
`UNIVERSITY
`(84%);
` FOOD
`&
`DRUG
`ADMINISTRATION (56%); FOOD & DRUG ADMINISTRATION (56%)
`
`Ticker: CELG (NASDAQ) (97%); CELG (NASDAQ) (97%); CELG
`
`Industry: PHARMACEUTICALS PRODUCT DEVELOPMENT (90%); ONCOLOGY (89%); CANCER DRUGS
`(89%); CLINICAL TRIALS (89%); ACADEMIC MEDICAL CENTERS (78%); CARDIOVASCULAR DRUGS (77%)
`
`Person: SOL J BARER (59%)
`
`Geographic: UNITED STATES (78%)
`
`Load-Date: December 12, 2001
`
`End of Document
`
`DR. REDDY’S LABS., INC. EX. 1012 PAGE 3
`
`