TORONTO — A drug company has been given the green light by Health Canada to market the long-established colorectal cancer drug oxaliplatin.
Now that Sanofi-aventis Canada Inc. has received its notice of compliance, it alone holds the license to market the drug known by the trade name Eloxatin. The move means three other companies that sold versions of oxaliplatin at deep discount prices under Health Canada's special access program, will have to stop.
“Within the next 4 to 6 weeks we should be able to put [Eloxatin] in the market,” Joëlle Sissmann, vice-president of corporate affairs for Sanofi-aventis Canada Inc., said in a telephone interview from Montreal Monday.
“We got a call this morning that Sanofi had its notice of compliance and we were no longer allowed to sell our product,” Jennifer Wardrop, managing director of Sigmacon Lifesciences Inc., said in a telephone interview Monday.
Up until late last week, Sigmacon Lifesciences Inc. sold a 100 mg vial of the drug for $500. Two other companies sold it for comparable prices under the special access program, which provides unlicensed drugs to those with serious or life-threatening conditions when conventional therapies fail are unsuitable or are unavailable – as long as no licensed alternative is available.
Despite being the standard of care for colorectal cancer patients since 1999, the drug-maker Sanofi-aventis only recently sought a licence from Health Canada to market the chemotherapy, which it was granted on Friday.
That's because the company was waiting for data protection, which is a change in Canada's intellectual property rules that among other rules, confers eight years of market exclusivity. Data protection was needed for Sanofi-aventis because by the time it had completed clinical trials and found the best use of oxaliplatin, its product patent was expired.
The price to purchase the drug from Sanofi-aventis is $1,000 for a 100-milligram vial. Dr. Sissmann of Sanofi-aventis said that is the price agreed upon by the Patented Medicine Prices Review Board, which regulates patented medicines to ensure they are not excessive. And she said the drug has been at that price since 1999.
“It is very important that patients can access this drug,” said Ms. Sissmann, who noted that the company has given away $33-million worth of drugs in the past five years to Canadians.
But it will add hundreds of thousands, if not millions, to the drug budgets of some cancer agencies that had been purchasing the less costly versions of oxaliplatin from three other companies.
“It's going to hit the provinces very hard and very fast in a way they don't expect,” said Ms. Wardrop of Sigmacon Lifesciences.
Mark Dorreen, head of medical oncology with Capital Health in Nova Scotia, had estimated it would cost $500,000 more than what he is paying now.
“Unless anything changes, we'll be stuck with that for the next eight years,” he has said.
The drug is funded in every province except for Ontario, where it is currently under review.
An estimated 4,000 to 5,000 Canadians with colorectal cancer are treated with the drug each year.
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