Oncolytics Biotech Inc.’s ONCY lead pipeline candidate, Reolysin, has been granted orphan drug status by the EMA for the treatment of ovarian, fallopian tube and primary peritoneal cancers.
The company is also seeking orphan drug status for the candidate for the treatment of pancreatic cancer in the EU.
According to the company, ovarian cancer affects approximately 150,000 women at any given time in the EU and has a prevalence of approximately three women 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 four indications (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 high-grade gliomas in pediatric patients. Meanwhile, Reolysin is currently in several studies for a wide range of cancers including advanced or metastatic colorectal cancer and recurrent or metastatic pancreatic cancer. Being the lead candidate at Oncolytics, we expect investor focus to remain on further updates on Reolysin.
Oncolytics is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Cambrex Corp. CBM, Lannett Company, Inc. LCI and Cytokinetics Inc. CYTK. All three stocks sport a Zacks Rank #1 (Strong Buy).
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