Lorus’ cancer drug granted orphan drug status by EU

Lorus believes this endorsement indicates that the product has the potential to provide efficacy and a significant benefit to patients with this devastating condition. The new status of the drug strengthens its position in the EU as a phase III global registration clinical trial in pancreatic cancer nears completion.

In order for a medicinal product to be designated as an orphan medicinal product in the EU, the sponsor must establish that a satisfactory method of treatment, which has been authorized in the European Community, does not exist for the condition, or, if such a method exists, that the medicinal product will be of significant benefit to those affected by that condition.

“Virulizin has now achieved orphan drug status for pancreatic cancer in two of the largest markets in the world providing Lorus with an important advantage in these markets,” said Dr Jim Wright, CEO, Lorus. “Further, we believe that this additional status enhances the value of our lead anticancer drug asset.”

Orphan drug designation in the EU provides market exclusivity for 10 years (from products of the same mechanism of action or structural similarity) in pancreatic cancer as well as eligibility for fee reductions and the potential for accelerated review.

Virulizin received orphan drug status for pancreatic cancer in the United States in 2001.