Healthcare Industry News:  oxaliplatin 

Biopharmaceuticals Oncology Regulatory

 News Release - June 18, 2007

Health Canada approves new chemotherapy treatment for patients with metastatic colorectal cancer

LAVAL, QC, June 18 (Healthcare Sales & Marketing Network) - Health Canada has approved Eloxatin(R) (oxaliplatin for injection) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) (FOLFOX4) for use in first and second-line treatment of metastatic colorectal cancer. Clinical studies show that Eloxatin(R) in combination with 5-FU and LV (FOLFOX4) can prolong survival, shrink tumours and delay the progression of disease in patients with metastatic colorectal cancer.(1) In Canada, colorectal cancer is the second-leading cause of death from cancer.(2) Close to 50 per cent of patients diagnosed with colorectal cancer go on to develop metastatic colorectal cancer.(3)

"Combination therapies including Eloxatin are playing an active and current role in treatment for colorectal cancer," says Barry Stein, President of the Colorectal Cancer Association of Canada, and colorectal cancer survivor. "As someone who has gone through the process of finding an effective treatment for colorectal cancer, I am encouraged that the approval of Eloxatin will offer new hope for Canadians who suffer from this disease."

Eloxatin(R), manufactured by sanofi-aventis, is a platinum agent and is one of the first treatments in its class to show a significant level of activity in metastatic colorectal cancer.

Clinical Data

In an international clinical trial with Canadian investigation sites, patients with previously untreated metastatic colorectal cancer, receiving FOLFOX4 had a median survival of 19.4 months whereas those patients treated with irinotecan plus bolus 5-FU/LV (IFL) had a median survival of 14.6 months; p (less than) 0.0001. Patients treated with FOLFOX4 had a significantly higher overall response rate (p (equal sign) 0.0075) and a longer time to disease progression (8.7 months vs. 6.9 months; p (equal sign) 0.0014).(4)

Additional clinical data have shown that in previously treated metastatic colorectal cancer, FOLFOX4 is superior to infusional 5-FU/LV in terms of time to progression and response rate. In a clinical trial, the median time to progression for FOLFOX4 was 5.3 months versus 2.6 months for 5-FU/LV (p (equal sign) 0.001). Patients treated with FOLFOX4 also had a significantly higher overall response rate (p (equal sign) 0.001). (1),(4) Eloxatin(R)-based chemotherapy has also been shown to be as effective in patients older than 65 as it is in younger individuals.

"Treating patients with combination Eloxatin offers my patients new hope of improving their survival time," says Dr. Scot Dowden, a medical oncologist with the Tom Baker Cancer Centre in Calgary. "This is an important advance in the management of metastatic colorectal cancer."

About Eloxatin(R)

Eloxatin(R) is one of the first treatments in its class (DACH-platinum) to show a significant level of activity in metastatic colorectal cancer. The platinum attached to Eloxatin(R) binds to the DNA in cancer cells, disrupting the cells' ability to reproduce.

Eloxatin(R) is currently available in more than 60 countries. In Canada, Eloxatin(R) in combination with infusional 5-FU and LV (FOLFOX4), is now indicated for the treatment of metastatic colorectal cancer. Eloxatin(R) in combination with 5-FU/LV (FOLFOX4) in the treatment of metastatic colorectal cancer is given every 14 days.

Side effects observed in the clinical trial setting included: fatigue, neuropathy, nausea, vomiting, diarrhea, stomatitis, neutropenia, thrombocytopenia, anemia, abnormalities of the liver function and respiratory problems. Anaphylactic reactions have been reported and may occur within minutes of Eloxatin(R) administration. Eloxatin(R) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

Sanofi-aventis has also filed a dossier to Health Canada for Eloxatin(R) in the adjuvant setting for colon cancer. This dossier is currently under review.

About Colorectal Cancer in Canada

In 2007, an estimated 20,800 Canadians will be diagnosed with colorectal cancer and an estimated 8,700 will die from the disease. Of the 8,700 estimated deaths, about 46 per cent will be women and 54 per cent men.(2)

One in 16 women is expected to develop colorectal cancer during her lifetime and one in 31 will die from the disease. One in 14 men is expected to develop colorectal cancer during his lifetime and one in 28 will die from the disease.(2)

Metastases are present in about 25 per cent of patients with colorectal cancer at diagnosis where the average spontaneous rate of survival is limited to five-to-six months. The primary site of metastasis is in the liver with 50 to 70 per cent of patients having hepatic metastasis during the course of their cancer.

About sanofi-aventis

Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY ).

In Canada, sanofi-aventis employs more than 1,140 people and is headquartered in Laval, Quebec.

This year marks a significant milestone as sanofi-aventis is celebrating its 50th anniversary in oncology research and treatment.

1. Rothenberg ML, Oza AM, Bigelow RH, et al. Superiority of oxaliplatin
and fluorouracil-leucovorin compared with either therapy alone in
patients with progressive colorectal cancer after irinotecan and
fluorouracil-leucovorin: interim results of a phase III trial.
Journal of Clinical Oncology. 2003 Jun 1;21(11):2049-51.
2. Canadian Cancer Society.
cw_2007stats_ en.pdf .
Accessed on: May 4, 2007.
4. Eloxatin(R) (oxaliplatin for injection) Product Monograph dated
June 15, 2007, sanofi-aventis Canada Inc.

Source: sanofi-aventis

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Please address inquiries directly to the issuing company.

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