- Alexion Pharmaceuticals lost a court battle over Canada's right to place a price cap on Soliris, its complement-mediated disorders drug, Canada's Patented Medicine Prices Review Board announced last week.
- The Board is responsible for regulating patented drug prices to ensure it "protects the interests of Canadian consumers," according to its press release. Alexion claimed this power was unconstitutional. The court struck down Alexion's claim due to judicial precedent.
- The court also demanded the company lower the list-price for Soliris and pay back the revenue from excess-pricing between 2012 and the first half of 2014. Alexion has vowed to appeal the decision, reports Stat.
Soliris, which is used to treat two very rare diseases, paroxysmal nocturnal hemoglobinura and atypical hemolytic uremic syndrome, ranges in price in the U.S. from $383,000 to $585,000, depending on which condition is being treated. The prices are mainly supported in the U.S. due to its small treatable population, but Canada's Patented Medicine Prices Review Board determines prices differently.
The board assesses the median price in seven other countries, including the U.S., France, the U.K., Germany Italy, Sweden and Switzerland to decide an appropriate list-price.
Alexion had asked a Canadian federal court to rule on the board's authority to regulate drug prices, but its application was dismissed. The company plans to appeal the dismissal decision.
An American rare-disease pharmaceutical company, Alexion has three products on the market: Soliris, Strensiq, and Kanuma. Soliris, which was approved by the FDA in 2007, has accounted for over 99% of the company's revenue since 2014. Kanuma and Strensiq were both approved by the FDA in the last quarter of 2015, and represented 5% ($35.5 million in revenue) of the company's revenue during the first quarter of 2016.