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FDA Approves Oxaliplatin for the First Line Treatment of Metastatic Colorectal Cancer

PARIS, Jan. 12, 2004 - Sanofi-Synthélabo (Euronext: “SAN”/NYSE: SNY) announced today that ELOXATIN (oxaliplatin for injection) in combination with 5FU/LV has been approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of advanced colorectal cancer. ELOXATIN™ was already approved in August 2002 for second-line treatment of patients with metastatic carcinoma of the colon or rectum in the US.

This new approval recommends now the use of ELOXATIN™, in combination with infusional 5FU/LV, for the treatment of advanced carcinoma of colon or rectum.

The supplemental New Drug Application (sNDA) for ELOXATIN™ in this indication had been submitted on July 11, 2003 in the United States and was granted a six-month priority review in September 2003.

Clinical data show that patients with advanced colorectal cancer treated with ELOXATIN™ given in combination with 5-FU/LV as first-line chemotherapy had a statistically significant improvement of nearly five months in median survival time compared to patients treated with a standard treatment of irinotecan in combination with 5-FU/LV.

“The finding that the oxaliplatin-based regimen demonstrated a longer survival time for patients is a major step forward.” said Richard M. Goldberg, M.D., Professor and Division Chief at University of North Carolina (Chapel Hill School of Medicine). “This is the greatest increase in survival time we have seen in a chemotherapy regimen used in advanced colorectal cancer and positions the oxaliplatin-based regimen as an emerging standard of care for patients with colorectal cancer.”

Clinical Trial Results
The study, upon which the FDA approval was based, was an NCI-sponsored trial, N 9741, coordinated by the North Central Cancer Treatment Group (NCCTG). The study demonstrated that patients treated first with ELOXATIN™ combined with infusional 5-fluorouracil and leucovorin (5-FU/LV), a regimen known as FOLFOX, had an overall median survival time of 19.4 months after the initiation of treatment, compared to 14.6 months in patients treated with a standard combination of irinotecan plus bolus 5-FU/LV, a regimen known as IFL. This represents a median survival advantage of 4.8 months for patients treated with FOLFOX, a 35% improvement.

In addition to the survival advantage, patients on FOLFOX also had a significantly higher overall tumor response rate in patients with measurable disease at baseline (45% vs. 33%) and a significantly longer time to disease progression (8.7 months vs. 6.9 months) than those on IFL. The side effects experienced by the group taking FOLFOX also were less severe, more manageable, and more often reversible than those reported by the IFL group. The most commonly reported side effects in patients treated with FOLFOX included neutropenia (decrease in white blood cells) and paresthesia (numbness or tingling). Based on these results, the investigators concluded that FOLFOX should be considered a standard first-line therapy for advanced colorectal cancer.

In March 2003, ELOXATIN™ was incorporated into the National Comprehensive Cancer Network (NCCN) colorectal cancer treatment guidelines.

ELOXATIN™ Status
ELOXATIN™ received marketing 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 a mutual recognition procedure, France being the Reference Member State.

ELOXATIN™ successfully completed a Mutual Recognition Procedure in Europe in December 2003, which will allow 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).

ELOXATIN™ is currently marketed by Sanofi-Synthelabo in more than 60 countries for the 1st and/or 2nd line treatment of metastatic colorectal cancer.

Global sales of ELOXATIN™ reached EUR 600 million for the first nine months of 2003, and should exceed EUR 800 million for the full year 2003.

Oxaliplatin is developed in association with Debiopharm S.A.

Colorectal Cancer Leading Cause of Death
About one million new cases of colorectal cancer are diagnosed worldwide every year, and about 150,000 new cases in the U.S. According to the American Cancer Society, colorectal cancer is the second leading cause of malignancy-related death in the U.S., accounting for 10 to 15% of all cancer death. Over a lifetime, about one in 18 people develop colorectal cancer, and, each year, about 56,000 people die from it in the U.S.

Further development in other types of cancer
Moreover an extensive worldwide clinical development program is ongoing to explore the benefit of ELOXATIN™ in other types of cancers.

Clinical Considerations about ELOXATIN™ in the United States
In the United States, ELOXATIN™ (oxaliplatin for injection), used in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV), is indicated for the treatment of advanced carcinoma of the colon or rectum.

Source: Sanofi-Synthélabo

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