French drug maker
began trading on the New York Stock Exchange Monday, giving U.S. investors a relatively easy way to play what should be an exciting new cancer drug.
The drug is called oxaliplatin, and after receiving
glowing reviews at this year's American Society of Clinical Oncology annual meeting, it's expected to become part of the standard of care for patients with advanced colon cancer -- replacing, irinotecan, a drug sold by
Oxaliplatin is actually an old chemotherapy drug, approved in Europe in 1996, but its introduction in the United States has been slow in coming. Sanofi-Synthelabo was granted fast-track status for oxaliplatin in April and completed its U.S. approval application for the drug last month. The Food and Drug Administration should issue its decision by the end of the year.
At this year's ASCO meeting, held in May, the French drug maker reported that oxaliplatin, when used in combination with two standard chemo drugs, delayed tumor progression and extended survival in patients with advanced colon cancer. This drug cocktail, known as FOLFOX, beat out what is now standard therapy in the United States -- the Saltz regimen: irinotecan plus the same two standard chemo drugs.
"Oxaliplatin will be accepted quickly and widely used in the United States, based on the data presented at ASCO," says Dr. Louis Weiner, chairman of the medical oncology department at the Fox Chase Cancer Center in Philadelphia.
"What you'll see is FOLFOX becoming the standard of care in front-line metastatic cancer patients, over the Saltz regimen," he added. "Irinotecan will still be widely used, but as a second-line treatment, or once a patient's cancer has progressed after taking oxaliplatin."
Oxaliplatin sales in Europe grew 41% in 2001 to $193 million. But if the drug is approved here, as expected, it will gain a foothold in a much larger cancer drug market. By comparison, irinotecan sales in 2001 grew 39% to $613 million, reported Pharmacia. Irinotecan is also known by the brand name Camptosar, or by its scientific name, CPT-11.
One potential negative for oxaliplatin, however, is its relatively short patent life. Analysts believe generic versions of oxaliplatin could reach the market in a few years, if Sanofi-Synthelabo doesn't come up with an improved version of the drug.
The drug maker tried, unsuccessfully, to get oxaliplatin approved in the United States in 2000, but the drug was rejected because clinical trials done at that time did now show a clear survival benefit over existing therapies.
The three drugs in the FOLFOX regimen are oxaliplatin, 5-fluorouracil (5-FU) and leucovorin. Patients treated with FOLFOX lived for a median of 18 months after beginning therapy, compared to 14 months for patients receiving the Saltz regimen. One year after beginning treatment, 70% of patients receiving FOLFOX were still living, compared to 57% who received standard therapy, according to results from a clinical trial of 795 patients. The National Cancer Institute and the North Central Cancer Treatment Group conducted the study.
Sanofi-Synthelabo shares closed Monday at $29.77.