UniQure and Chiesi's gene therapy Glybera for lipoprotein lipase deficiency (LPLD) is set to go on sale in Germany at a cost of 1.1 million euros ($1.4 million), as reported Thursday in The Guardian.
Glybera was approved in Europe two years ago, but its launch has been delayed to allow for the collection of follow-up data on its benefits.
Chiesi has now filed a pricing dossier with Germany's federal joint committee (G-BA), which will issue an assessment of the drug’s benefits by the end of April next year.
Under German rules, the launch price for a new drug is valid for the first 12 months, with each vial of Glybera having a retail price of 53,000 euros per vial.
A Chiesi spokeswoman noted that a final figure would be set after the G-BA gives its verdict and negotiations are held with statutory health insurance funds, adding that "first commercial treatments are expected in the first half 2015."
UniQure, which will get a net royalty of between 23 percent and 30 percent on sales, also has plans to seek approval for Glybera in the US, which it hopes to get in 2018.