Oncolytics Biotech Inc. (ONCY) announced that it has submitted applications to the FDA seeking orphan drug designation for its oncology candidate, Reolysin. The orphan status has been sought for Reolysin for the treatment of pancreatic and ovarian cancer.
We note that the FDA grants orphan drug designation to candidates being developed to treat rare diseases/disorders that affect less than 200,000 people in the U.S. The status makes the candidate eligible for seven years of marketing exclusivity in the U.S., following approval. If the orphan drug designation is granted to Reolysin, it will also make Oncolytics eligible for certain other benefits, including potential tax credits for certain activities, eligibility for orphan drug grants and the waiver of certain administrative fees.
As per data provided by the American Cancer Society, 46,420 and 21,908 people in the U.S. are expected to be diagnosed with pancreatic cancer and ovarian cancer in 2014. The prognosis for patients diagnosed with pancreatic cancer is bleak given the relative five-year survival rate of only 6%. The prognosis for ovarian cancer patients is better than those afflicted by pancreatic cancer given the relative 10-year survival rate of approximately 35%. However, the prognosis rates do indicate a need for newer therapies.
Oncolytics is developing Reolysin as a monotherapy or in combination with chemotherapy for several other indications including head and neck cancer, lung cancer and metastatic melanoma.
Oncolytics carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Amgen Inc. (AMGN), AMAG Pharmaceuticals, Inc. (AMAG) and Actavis (ACT). While Amgen carries a Zacks Rank #1 (Strong Buy), AMAG Pharma and Actavis carry the same rank as Oncolytics.
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