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European Union Grants Virulizin Orphan Drug Status
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(R) 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.
Virulizin is a novel immunotherapy that stimulates a patient's innate immune system through the activation of macrophages and the infiltration of NK cells into tumors. Virulizin is currently in a fully enrolled pivotal Phase III registration clinical trial in North America, South America and Europe. It has been awarded orphan drug, fast track status and a Special Protocol Assessment (SPA) from the F.D.A. in the U.S. Lorus anticipates having the full data set from the Phase III clinical trial in the fourth quarter of calendar 2005.
About Pancreatic Cancer
Pancreatic cancer is one of the most lethal human cancers and continues to be a major unsolved health problem at the start of the 21st century. This is due to the lack of effective treatment options available at present for the pancreatic cancer patient. Despite efforts in the past 50 years, conventional treatment approaches such as surgery, radiation, chemotherapy, or combinations of these, have had little impact on the course of their aggressive neoplasm. Therefore, development of novel therapeutics of treatment of this type of cancer is important to improve patient prognosis.
The incidence of pancreatic cancer in the EU is 1.2 per 10,000 per annum. In the US, a total of approximately 30,000 new cases of pancreatic cancer are diagnosed each year, compared to approximately 53,000 cases per annum in the EU.
Source: Lorus Therapeutics Inc.