Recordati seeks Canada's approval for a kidney disease drug

TORONTO (Reuters) – Italy's Recordati announced on Tuesday that it will seek Canadian approval for Cystagon, a rare kidney disease drug, which could hurt Horizon Pharma, the only drug approved for treatment in Canada.

Procysbi, the drug used by Cystagon and Horizon, uses the same active ingredient to treat nephropathic cystinosis, a genetic disease that can cause life-threatening kidney damage. In Canada, only about 100 people have the disease, but at current prices, Procysbi costs $ 325,000 Canadian ($ 243,336.33) a year, according to Canadian regulators.

Cystagon, manufactured by Mylan Pharmaceuticals and sold in Canada and Europe by Recordati, has been available in Canada for over two decades as part of a special program allowing patients to use unapproved drugs in the country as long as there is no alternative available.

In 2017, Horizon received Procysbi approval from Health Canada, making it much more difficult for Canadian patients to access Cystagon.

Canadian approval of Cystagon, which Recordati claims would cost about $ 25,000 a year, would make the drug cheaper again. Approximately 13% of Horizon's net sales in 2018 came from the sale of Procysbi in the United States and Canada.

"Recordati plans to seek Health Canada's approval of Cystagon," Recordati said in an e-mailed statement. "We are following this process to ensure that patients in Canada's Special Access Program do not have to change their treatment to a similar, much more expensive drug."

Recordati has announced its intention to seek this approval this year. He said the approval process would probably take about a year.

PRIZE DISPUTES

In January, the Patented Medicine Prices Review Board (PMPRB), the federal drug price regulator, requested an order that would require Horizon to reduce Procysbi's price and pay back 3.2 millions of Canadian dollars to public drug plans. Horizon is opposed to the order. The case could end up in federal court and take years to resolve.

"The review and approval of Cystagon by Health Canada would be good news for people with cystinosis – we think it's always good that rare disease patients and their families have more choices," he said. Horizon in a statement.

The company argued that Procysbi is a superior drug because it is taken every 12 hours, instead of every six hours, to help patients stay on treatment and live longer.

Horizon says it has spent $ 180 million to develop Procysbi and provide free drugs to patients not benefiting from insurance, as well as undisclosed discounts to public drug plans.

Last year, Horizon recorded a $ 37.9 million impairment loss related to Procysbi, citing the potential for future sales to decline as a result of the PMPRB's case.

Prescription drugs are often sold at prices below their list prices, but discounts are usually secret. In Canada, employer-sponsored private drug plans that cover the majority of patients are more likely to pay the current price of new drugs than public programs.