Oncolytics Biotech Inc.’s ONCY lead pipeline candidate, Reolysin has been granted orphan drug status by the EMA for the treatment of pancreatic cancer.
Reolysin already enjoys orphan drug status for other indications in the EU including ovarian, fallopian tube and primary peritoneal cancers.
According to the company, pancreatic cancer affects approximately 45,300 people in the EU at any given time, occurring at a frequency of about 0.88 patients per 10,000.
The EMA usually grants orphan drug status to drugs that are being developed for the treatment of life threatening and debilitating diseases affecting no more than five in 10,000 people in the EU, for which no satisfactory method of treatment, prevention or diagnosis exists. This designation allows the product to enjoy a 10-year period of marketing exclusivity in the EU, upon approval. Incentives that come with orphan drug status include protocol assistance and potential fee reductions.
We note that Reolysin already has orphan drug status for several indications (malignant gliomas, primary peritoneal cancer, fallopian tube cancer, ovarian cancer and pancreatic cancer) in the U.S.
Oncolytics is also seeking orphan drug designation for Reolysin in the U.S. for the treatment of gastric cancer. Meanwhile, Reolysin is currently in several studies for a wide range of cancers including advanced or metastatic colorectal cancer and advanced or metastatic pancreatic cancer. Being the lead candidate at Oncolytics, we expect investor focus to remain on further updates on Reolysin.
Oncolytics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include CorMedix, Inc. CRMD, Aeterna Zentaris Inc. AEZS and Biogen BIIB. All three sport a Zacks Rank #1 (Strong Buy).
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