Bristol-Myers Squibb Announces Major TAXOL(R) Milestone

For The Treatment Of Breast Cancer Brussels (PROTEXT) - Filing for new European registrationbased on largest-ever TAXOL clinical trial. Bristol-Myers Squibb Company (NYSE: BMY) announced today thatan application for European marketing authorization has beensubmitted to the Dutch Health Authorities for the use of TAXOL(R)(paclitaxel) for the adjuvant treatment of node-positive breastcancer. Of the more than 250,000 women diagnosed with breastcancer each year in the E.U., approximately 102,500 arecandidates for adjuvant therapy. The Dutch Health Authorities are central to the regulatoryreview of TAXOL in the European Union. Submissions to the other14 E.U. member states are now ongoing. The European filingclosely follows a supplemental New Drug Application for the sameindication, which was submitted to U.S. FDA in April of thisyear. Central to the U.S. and European applications are the resultsof a major Phase III adjuvant breast cancer trial led by theCancer and Leukemia Group B (CALGB) Cooperative Cancer ResearchGroup, a leading clinical research organization in the U.S.sponsored by the National Cancer Institute. The study (CALGB-9344) is the largest TAXOL study ever conducted. It enrolled morethan 3,000 women whose breast cancer spread to the lymph nodes. These patients were randomized to receive either the standardadjuvant treatment combination -- doxorubicin pluscyclophosphamide -- or doxorubicin plus cyclophosphamide,followed by TAXOL. Results of a planned interim analysis of thistrial have shown that the sequential addition of TAXOL to thestandard combination reduces risk of death by 26 percent andreduces the risk of cancer recurrence by 22 percent. Trialresults have been updated with a 30-month analysis, also includedin the U.S. and European regulatory filings. "The interim analysis of CALGB-9344 represents the single mostsignificant advance in the treatment of early-stage breast cancerin the past 20 years since the introduction of doxorubicin," saidRichard L. Schilsky, M.D., director, University of Chicago CancerResearch Center; professor of medicine, University of Chicago andchairman, CALGB. "This new combination has the potential to savetens of thousands of lives worldwide each year." "If approved, this regimen will represent a new standard forpatients with breast cancer," said Larry Norton, M.D., Head,Division of Solid Tumor Oncology, Memorial Sloan Kettering CancerCenter and Chair of the CALGB's breast committee. Dr. Nortonemphasized that experience from other landmark breast canceradjuvant trials suggests that the early benefit defined by CALGB-9344 will be maintained with continued follow-up. Other U.S. cancer cooperative groups involved in the studywere the Eastern Cooperative Oncology Group, the SouthwestOncology Group and the North Central Cancer Treatment Group,which are all sponsored and supported by the National CancerInstitute. In all, several hundred institutions participated. Breast cancer is the most common cancer in women and theleading cause of female cancer death in the E.U. Currently, onein 10 European women have a lifetime risk of developing breastcancer. Improvements in early detection and treatment havedriven reductions in mortality in some countries, and they remaina major focus of the breast cancer research community. Expertsrecently have emphasized that the rapid development of betteradjuvant chemotherapy regimens is a short-term priority forimproved breast cancer outcomes throughout Europe(1). "Widespread availability of TAXOL for the adjuvant treatmentof breast cancer will give European physicians and patients apowerful new tool to combat disease and increase chance of cure,"said Professor David Khayat, Head, Department of MedicalOncology, Salpetriere Hospital, Paris, who provided the expertreport for the European filing. "If we can decrease risk ofdeath by 26 percent in the large European patient populationeligible for adjuvant therapy, the implications will bestaggering." "As promising new adjuvant regimens are developed, it becomeseven more crucial that women throughout Europe better understandthe importance of breast awareness, screening and earlydetection," said Gloria Freilich, President of Europa Donna, apan-European breast cancer patient advocacy organization. "Thecombination of early detection and widespread access toclinically proven, powerful new therapies will mean that morewomen with breast cancer will survive this disease than everbefore." Adjuvant chemotherapy is treatment used very soon aftersurgery, primarily in early stage disease. In breast cancer,adjuvant chemotherapy is used in addition to surgery with theobjective of curing the patient. Adjuvant therapies, includingchemotherapy, hormone and radiation therapy, are used eitheralone or in combination to combat the disease systemically. Currently TAXOL is approved as first-line (in combination withcisplatin) and subsequent therapy, for the treatment of advancedcarcinoma of the ovary, and for the treatment of breast cancer,after failure of combination chemotherapy for metastatic diseaseor relapse within six months of adjuvant chemotherapy. Priortherapy should have included an anthracyline, unless clinicallycontraindicated. TAXOL is also indicated for use in combination with cisplatin,for the first-line treatment of non-small cell lung cancer inpatients who are not candidates for potentially curative surgeryand/or radiation therapy. Bristol-Myers Squibb is a diversified worldwide health andpersonal care company whose principal businesses arepharmaceuticals, consumer medicines, beauty care, nutritionalsand medical devices. It is a leading maker of innovativetherapies for cardiovascular, metabolic and infectious diseases,central nervous system and dermatological disorders and cancer.The world leader in oncology, Bristol-Myers Squibb is deeplycommitted to cancer research, clinical development and patientcare. (1) Significant Promise of Adjuvant Therapy Requires ClinicalTrial Commitment; official communication of the First EuropeanBreast Cancer Conference, October 2 1998.

Visit Bristol-Myers Squibb on the World Wide Webb at:http://www.bms.com ots Original Text Service: Bristol-MyersSquibb Internet: http://www.newsaktuell.de Contact: AnnaMariaDeSalva of Bristol-Myers Squibb 001-212-546-4393, 001-917-539-3905, or annamaria.desalva@bms.com Company News On-Call:http://www.prnewswire.com or Fax, 001 201-432-0504, ext. 269329Web site: http://www.bms.com

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