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Eloxatin (Oxaliplatin) to Receive Expanded Indication in Europe for Early Stage Colon Cancer Treatment

PARIS, FRANCE -- September 17, 2004 -- The sanofi-aventis Group (PARIS: SAN, NYSE: SNY) announced today that its anti-cancer agent EloxatinŽ (oxaliplatin), which is currently marketed for the "treatment of Metastatic Colorectal Cancer in combination with 5-fluorouracil and folinic acid" has successfully completed a Mutual Recognition Procedure in Europe, which will result in an extended indication for the product in the adjuvant setting:

"Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor".

The European approval was based on the results of the landmark adjuvant clinical trial, MOSAIC, which was recently published in June 2004 in the New England Journal of Medicine.

MOSAIC is a large, international randomized Phase III trial involving 2,246 patients in 148 centres and 20 countries. The primary objective of the study was to evaluate the Disease Free Survival (time to relapse or death) in these patients, all of whom had a completely resected stage II/III colon cancer and received the current standard of adjuvant chemotherapy for colon cancer (5-fluorouracil/leucovorin known as 5-FU/LV) with or without the addition of Eloxatin.

The Mosaic trial demonstrated that the addition of Eloxatin to 5-FU/LV increased Disease Free Survival at 3 years to 78.2% versus 72.9% for 5-FU/LV alone (p=0.002), with a 23% reduction in the risk of recurrence in the overall study population. For patients with stage III colon cancer, 3-year Disease Free Survival was 72.2% with the addition of Eloxatin and 65.3% for 5-FU/LV alone, with a 24% reduction in the risk of recurrence(1).

These were the very first results to demonstrate a significant benefit over 5-FU/LV alone in this setting, and provide early-stage colon cancer patients with new hope for potential cure of their disease.

"The MOSAIC trial demonstrates that surgical removal of the primary tumour and treatment with Eloxatin-based chemotherapy can increase the chances for patients with early-stage colon cancer to be cured," said Aimery de Gramont MD PhD, Professor of Medicine and Director of the Oncology Department, Saint- Antoine Hospital, Paris and principal investigator of the MOSAIC trial. "We are pleased to see that Eloxatin-based adjuvant therapy will now be made available to these patients in the European Union."

The addition of Eloxatin to 5-FU/LV is well tolerated. The most frequently reported side effect was neutropenia (decrease in the number of white blood cells) but this was complicated by fever or infection in only 1.8 % of cases. Among patients experiencing peripheral sensory neuropathy ("pins and needles" in the fingers), partial or total recovery was observed in almost all cases within a period of six months following treatment.

On the basis of the MOSAIC trial findings, a supplemental New Drug Application (sNDA) was also submitted to the Food and Drug Administration (FDA) in the US in early 2004 to include the adjuvant treatment of patients with colon cancer in the labelling of Eloxatin. An extension of the approval to include the adjuvant treatment of patients with colon cancer has also been applied for in several other countries including Switzerland and Australia.

About EloxatinŽ

Eloxatin received approval in France for the 2nd line treatment of metastatic colorectal cancer in April 1996, and as a 1st line treatment in April 1998. In July 1999, Eloxatin was approved for the 1st line treatment indication in major European countries, through the Mutual Recognition Procedure, France being the Reference Member State.

Eloxatin has successfully completed a Mutual Recognition Procedure in Europe in December 2003, which allowed the product to be indicated for the full indication: "Treatment of Metastatic Colorectal Cancer in combination with 5-fluorouracil and folinic acid" (i.e., 1st line and 2nd line treatment). In the U.S., Eloxatin received marketing approval on January 9, 2004, for the first line treatment of metastatic carcinoma of the colon or rectum. This approval recommends the use of Eloxatin, in combination with infusional 5-FU/LV, for the treatment of advanced carcinoma of the colon or rectum. Eloxatin had previously (August 2002) received approval for second line treatment of these patients.

Eloxatin is currently marketed by sanofi-aventis in more than 60 countries for the treatment of metastatic colorectal.



Colorectal Cancer Leading Cause of Death

Colorectal cancer is the third leading cause of cancer and the forth leading cause of mortality due to cancer in the world. About one million new cases of colorectal cancer are diagnosed worldwide every year.

Further development in other types of cancer An extensive worldwide clinical development program is ongoing to explore the benefit of Eloxatin in other types of cancer.

References:

(1) T. ANDRE, C. BONI, L. MOUNEDJI-BOUDIAF, M. NAVARRO, J. TABERNERO, T. HICKISH, C. TOPHAM, M. ZANINELLI, P. CLINGAN, J. BRIDGEWATER, I. TABAH-FISCH, A. DE GRAMONT. Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer. (MOSAIC). New Engl. J. Med., 2004; 350: 2343-2351".

SOURCE: sanofi-aventis Group

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