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Lorus Therapeutics has announced that the EMEA (European Medicines Agency) has given a positive opinion on Lorus' application for orphan drug status to Virulizin, the company's lead anticancer drug for the treatment of pancreatic cancer.

This most recent orphan drug status designation for Virulizin indicates that the product has potential to provide efficacy and a significant benefit to patients with this devastating condition. This positive opinion also strengthens the product's position in the European Union (EU), as the Phase III global registration clinical trial in pancreatic cancer nears completion during the second half of this calendar year. Virulizin received orphan drug status for pancreatic cancer in the United States from the Food and Drug Administration (FDA) in 2001.

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.

Significant benefit is defined in Commission Regulation (EC) 847/2000 as a 'clinically relevant advantage or a major contribution to patient care'. The applicant is required to justify the assumption that the medicinal product will be of significant benefit compared to the existing authorized medicinal products or methods at the time of designation.

"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.

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June 9, 2005 05:36 PMHealth & Medicine

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