Taxotere(R) Study Shows Improved Survival And Reduced Relapse In Early-Stage Breast Cancer Second Interim Analysis to Support U.S. and EU Registrational Submissions for Adjuvant Breast Cancer SAN ANTONIO, Dec. 5 /PRNewswire-FirstCall/ -- An updated analysis of an important study shows the Aventis chemotherapy agent Taxotere(R) (docetaxel) Injection Concentrate significantly improved the survival rate of women with early-stage breast cancer and reduced their risk of a relapse compared with a standard treatment. The Breast Cancer International Research Group (BCIRG) 001/ TAX 316 study, presented at the San Antonio Breast Cancer Symposium on December 5, showed women with node-positive, early-stage breast cancer who received a Taxotere(R)-based chemotherapy regimen after surgery experienced a 30 percent reduction in the risk of death at a 55-month follow-up and a 28 percent reduction in the chance of their cancer returning as compared to women treated with a commonly used, standard (post-surgery) adjuvant regimen. The first analysis of BCIRG001 presented at the American Society of Clinical Oncology (ASCO) in May 2002 by Dr. Jean Marc Nabholtz, who designed the trial, showed that the Taxotere(R) combination arm had strong activity in both women with hormone-receptor positive or hormone-receptor negative tumors. The current analysis shows Taxotere(R) to be the only taxane that demonstrates a disease-free survival benefit for women, regardless of hormone-receptor status of their tumors. Aventis plans to use the phase III study data to support submissions for U.S. and EU approval in early 2004 for the use of Taxotere(R) in treating early-stage operable breast cancer with involved axillary lymph nodes. Taxotere(R) is currently indicated as a therapy for treatment of locally advanced or metastatic breast cancer after prior failure of chemotherapy. "These mature data, which reflect nearly five years of follow-up, are exciting as they demonstrate that adding Taxotere(R) to a standard anthracycline regimen in the adjuvant setting can significantly reduce the risk of relapse for women with early-stage breast cancer," said John Mackey, M.D., a member of the BCIRG Scientific Committee and Chair of the Northern Alberta Breast Cancer Program at the Cross Cancer Institute in Edmonton, Canada. "The results of this study suggest that we may be able to cure more women with early-stage disease by providing them a highly effective adjuvant chemotherapy regimen." Study Results and Protocol The study compared the combination of Taxotere(R), doxorubicin (Adriamycin(R)) and cyclophosphamide (Cytoxan(R)), (TAC), with the standard regimen of 5-fluorouracil, doxorubicin and cyclophosphamide, (FAC). The 55- month follow-up results from this study were presented as a late-breaking oral presentation at the San Antonio symposium. The multi-center study, conducted by BCIRG, enrolled 1,491 pre- and post- menopausal women with early-stage breast cancer from 112 sites in 20 countries between June 1997 and June 1999. Women were randomized to receive either TAC or FAC in the adjuvant (post-surgery) setting. Among the findings of the study was a 28 percent improvement in the primary endpoint of disease-free survival (p=0.0010) for patients treated with TAC as compared to FAC. A similar benefit was observed regardless of nodal, hormone-receptor and HER-2/neu status. The study also showed a 30 percent reduction in the risk of death (p=0.0080) for women treated with the Taxotere(R)-based regimen. "The outcomes from this important trial demonstrate that Taxotere(R) extends the lives of woman with node positive disease," said Dr. Frank Douglas, Executive Vice President for Drug Innovation & Approval and a Member of the Management Board of Aventis. "We are encouraged by these results in early-stage breast cancer, and we will be using this data to support our submissions for regulatory approval early next year for Taxotere(R) in this setting." Adverse Events Manageable Long-term follow-up of women on the study did not identify any new safety concerns beyond those already presented at the time of the first interim analysis. Specifically, the TAC regimen was associated with a higher rate of febrile neutropenia (low white blood cell count that can lead to infections) compared with FAC (24.7 percent versus 2.5 percent). However, this increase in febrile neutropenia did not lead to an increased incidence of severe infection, and there were no toxic deaths from infection. Also, patients in the study were not treated prophylactically with GCSF (granulocyte colony-stimulating factor), an effective and widely used agent to prevent neutropenia in chemotherapy patients. The study compared an equal number of treatment cycles for both treatment groups and more than 90 percent of patients in both treatment groups received all six cycles of treatment. Breast Cancer Breast cancer is the most common cancer among women other than skin cancer. It is the second-leading cause of cancer death in women after lung cancer -- and is the leading cause of cancer death among women ages 40 to 59. More than 1,000,000 new cases of breast cancer are reported worldwide annually and more than 300,000 women die each year from the disease. The risk of a woman developing breast cancer during her lifetime is approximately 11 percent (about one in nine of all women), with about three to four percent dying of the disease. About Taxotere(R) Taxotere(R) (docetaxel) Injection Concentrate is an anticancer agent and a taxane that inhibits cell division by preventing microtubule disassembly during the cell cycle. Microtubules play an important structural role as the cell's skeleton during cellular growth and replication. By inhibiting the structural activity of the microtubules, and "freezing" the cell's internal skeleton, Taxotere(R) treatment interferes with a vital component of cellular replication, which can result in cell death. Taxotere(R) is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. The most common severe side effects associated with Taxotere(R) include low blood cell count, fatigue, fluid retention and mouth sores. The most common non-severe side effects included hair loss, neurosensory, cutaneous, nail changes, nausea and diarrhea. These side effects are generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere(R) is not appropriate therapy for patients with significant liver impairment or a low white blood cell count. Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere(R), visit http://www.taxotere.com/ or see full prescribing information including boxed WARNING. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com/. About Aventis Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of euro 17.6 billion (US $16.6 billion), invested euro 3.1 billion (US $3 billion) in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the U.S., please visit: http://www.aventis-us.com/. Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com/. Also available at this U.S. Web site are copies of this release or any recent release. Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Reference"- on file with the "Commission des Operations de Bourse" in France, recently renamed "Autorite des marches financiers". DATASOURCE: Aventis US Product Communications CONTACT: Lisa Kennedy, +1-908-243-6361, or , or Marisol Peron, +1-908-243-7592, or , both of Aventis US Product Communications Web site: http://www.aventis-us.com/ http://www.aventisoncology.com/ http://www.sabcs.org/ http://www.taxotere.com/

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