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Oxaliplatin Studies Demonstrate Effectiveness for All Stages of Colorectal Cancer

PARIS, June 2 /PRNewswire-FirstCall/ -- Sanofi-Synthelabo announced today major results on ELOXATIN presented at the 39th annual meeting of the American Society of Clinical Oncology (ASCO).

136 abstracts on ELOXATIN™ (oxaliplatin for injection) were published at the meeting and important new data were presented: from early stage of the disease, adjuvant treatment following surgery, to metastatic setting, 1st and 2nd /3rd line treatment. These results show that ELOXATIN is effective in all stages of the disease and hence significantly improve the quality and length of life for colorectal cancer patients.

In early stage: -- Results from the MOSAIC trial for the use of ELOXATIN as adjuvant therapy following surgery, presented by A. de Gramont In metastatic setting: -- Results from an NCI-sponsored 1st-line colorectal cancer trial - N 9741 - presented by R. Goldberg -- Results from a 2nd-line colorectal cancer trial - EFC 4584 - presented by M. Rothenberg -- Results from a 3rd-line colorectal cancer trial - EFC 4760 - presented by N. Kemeny

You will find attached 3 press releases (adjuvant, 1st line and 2nd line) issued at ASCO by investigators. Here is a brief overview of the results:

MOSAIC study (adjuvant therapy)

Efficacy results of the MOSAIC study demonstrated that the addition of oxaliplatin to the current post surgery standard chemotherapy, 5-fluorouracil/leucovorin (5-FU/LV), for colon cancer reduces the risk of recurrence by 23% vs. current standard treatment alone. This strong achievement, 15 years after 5-FU/LV was established as standard adjuvant treatment, is a major step towards curing more patients and was obtained with a favorable safety profile.

N 9741 study (1st line treatment for metastatic colorectal cancer)

The results of this NCI-sponsored trial, as reported by the Mayo Clinic, clearly show the superiority of the FOLFOX4 regimen (ELOXATIN + 5-FU/LV) versus the IFL regimen (irinotecan + 5-FU/LV), in terms of response rate (RR), progression free survival (PFS), overall survival (OS) and safety profile. The overall survival was 19.5 months with the FOLFOX regimen versus 14.8 months with the IFL regimen (p = 0.0001) giving an improvement of 4.7 months in favor of ELOXATIN-based treatment, representing a survival gain of more than 30%.

EFC 4584 study (2nd line treatment for metastatic colorectal cancer)

The study compared the FOLFOX4 regimen versus 5-FU/LV, as 2nd line treatment for metastatic colorectal cancer, after IFL regimen failure. The response rate and the progression free survival were significantly superior in the FOLFOX group. The overall survival was 9.8 months in the FOLFOX group versus 8.7 months in the 5-FU/LV group (p=0.07), clearly suggesting a trend for survival improvement, in this very difficult-to-treat patient population for which no viable option is available.

In addition, this study clearly demonstrated that ELOXATIN has significant improvement of disease-related symptoms.

With these very promising results, Sanofi-Synthelabo should file ELOXATIN in the United States, for the 1st line treatment for metastatic colorectal cancer (MCRC) in the early second half of the year 2003 and for the adjuvant treatment of colorectal cancer towards the end of the year 2003. The filing in Europe for the adjuvant treatment of colorectal cancer should occur in the second half of the year 2003.

In the US, ELOXATIN (oxaliplatin for injection) is approved for use in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV), and is currently indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within six months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan. The approval of ELOXATIN was based on the response rate and time to tumor progression observed in an ongoing trial. Data that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival were not available at approval.

ELOXATIN (oxaliplatin for injection) is a chemotherapeutic cancer agent and as such should be administered under the supervision of a qualified physician experienced in the use of such products.

ELOXATIN should not be administered to patients with a history of known allergy to ELOXATIN or other platinum compounds. Women of childbearing potential should be advised not to become pregnant while receiving treatment with ELOXATIN. As with other platinum compounds, hypersensitivity and anaphylactic/anaphylactoid reactions have been reported. ELOXATIN is associated with pulmonary toxicity, which may be fatal and two distinct types of primarily peripheral sensory neuropathies: an acute, reversible type of early onset and a persistent type (>14 days). An acute syndrome of pharyngolaryngeal dysesthesia seen in 1-2% of patients characterized by subjective sensations of dysphagia or dyspnea, without any laryngospasm or bronchospasm (no stridor or wheezing) may also occur.

Both 5-FU and ELOXATIN are associated with gastrointestinal and hematologic adverse events. When ELOXATIN is administered in combination with 5-FU, the incidence of these events is increased. The most frequently reported adverse events with ELOXATIN in combination with infusional 5-FU/LV are acute neuropathy (56%), persistent neuropathy (48%), fatigue (68%), diarrhea (67%), nausea (65%) and vomiting (40%). Changes in hematology parameters were also seen: anemia (81%), leukopenia (76%), neutropenia (73%), and thrombocytopenia (64%).

Full prescribing information including boxed warning is available through http://products.sanofi.us/eloxatin/eloxatin.html.

About one million new cases of colorectal cancer are diagnosed worldwide, 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.

ELOXATIN is currently marketed by Sanofi-Synthelabo in more than 60 countries for 1st and/or 2nd line metastatic colorectal cancer and is undergoing extensive worldwide clinical development for new indications. Global sales of ELOXATIN reached EUR 389 million in 2002. Sales for the first quarter 2003 were EUR 185 million. Oxaliplatin was developed in association with Debiopharm S.A.

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