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Quark Delayed Graft Function Drug Gets European Orphan Drug Status


Quark Pharmaceuticals this week announced that its investigational drug for the prevention of delayed graft function in kidney transplant patients has received an orphan drug designation from the European Commission.

The provisions for the EU orphan designation provide incentives to companies developing the products, including the potential for up to 10 years of market exclusivity and various fee reductions for certain regulatory activities, Quark said.

The drug, QPI-1002, is designed to temporarily inhibit p53, and received a similar designation from the US Food and Drug Administration earlier this year.

Last month, Quark announced that phase I data for QPI-1002 showed the compound to be safe, with no dose-limiting toxicities (GSN 5/6/2010).