Oncolytics Biotech Inc ONCY

Big Pharma fight with generic companies for small molecules

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Big Pharma's strategy to fight-off upcoming generic competition on small molecule drugs that are facing patent expiration has Big Pharma moving towards the acquistion of biological assets like ONCY's oncolyic virus Immune Molecule Technology Platfrom which is very difficult to copy in a generic format.  Furthermore innovative biological products like ONCY's pelareorep are given preferential treatment through the FDA's 12 market exclusivity starting on the day these biological drugs are approved for sale. 

Consequently ONCY's Immune Molecule Technology Platform (pelareorep) is an asset that addresses Big Pharma's strategy to have an asset treat multiple disease states as Big Pharma moves their operations towards the immuno-oncology biopharmaceutical space rather than their traditional small molecule focus.

https://www.fiercepharma.com/pharma/novartis-28b-ms-med-gilenya-exposed-generics-short-term-larger-supreme-court-decision-looms

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Because of the FDA's 12 year market exclusivity for an innovative biologial product, the combination of that new and innovative product, like ONCY's pelareorep, with one that is facing patent expiration, like many of the PD-(L)1 immune checkpoint inhibitors currently on the market, would then provide parallel protection for both products by virtue of the simple approval of the new and

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A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for Breakthrough Therapy designation to expedite its development and review. A product candidate can receive Breakthrough Therapy designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may