Pharmsynthez announced that the United States Food and Drug Administration (FDA) has unanimously awarded Virexxa, OJSC Pharmsynthez’s treatment for hormonotherapy-resistant endometrial cancer (a malignant tumor of the female reproductive system), orphan drug designation.
Virexxa is the first Russian pharmaceutical to be awarded the status of orphan drug in the United States. The market capacity for this product in the US is estimated at US$ 500 million per year. The FDA made its decision based on a positive ruling by the Committee for Orphan Medicinal Products that combined therapy based on Virexxa can provide considerable clinical advantage to patients with endometrial cancer that is resistant to hormonotherapy.
Pharmsynthez is currently investigating the effectiveness of the combined application of Virexxa and progestins in patients with advanced and relapsing endometrial cancer who developed a tolerance to progestins monotherapy. Phase II clinical trials are ongoing in several clinical centers in the Russian Federation. Phase II clinical trials in the European Union countries will be initiated in 2011 after the completion of manufacturing of the cGMP medicine series for clinical trials by KeveltAS, an enterprise acquired by Pharmsynthez earlier in 2011. As a result of the FDA’s decision to grant orphan drug designation, Pharmsynthez will also initiate clinical trials of Virexxa in the US in 2011, one year earlier than previously planned.
Dmitry Genkin, the Chairman of the Board of Directors of Pharmsynthez, said: “The assignment of orphan drug status in the USA for Virexxa is a highly important event for Pharmsynthez. It serves as recognition that our unique product has the potential to address a serious unmet medical need and is competitive in the high value US pharmaceutical market. In addition to guaranteeing our exclusive market position for seven years following registration, orphan drug designation reduces the time and expenses required to complete the clinical trial program for Virexxa in the US and so allows us to begin clinical trials in the US this year, earlier than originally planned.”