Oncolytics Biotech Inc T.ONC

Market Exclusivity for 'novel' biological drug products

[Noteable]

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of abbreviated new drug applications (ANDAs) or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition.

Under the Inflation Reduction Act (IRA), brand-name and biologic drugs without generic or biosimilar equivalents covered under Medicare Part D (retail prescription drugs) or Part B (administered by physicians) are provided exclusivity for nine (small-molecule drugs) or 13 or more years (biologicals) from the time of FDA approval. After this period of exclusivity brand-name and biologics are subject to generic or biosimilar equivalents competition and drug price reduction.

[Noteable]

And YES ... ONCY's pelareorep is a "different kettle of fish" since this is not only a platform technology but is also an immune stimulant that is capable of activating both the innate and adaptive immune system while converting an immunosuppressive and hypoxic tumor microenvironment environment (TME) thus making the TME conducive for the addition of PD-(L)1 checkpoint inhibitors

[Noteable]

Furthermore an accelerated approval under the new FDA guidelines that passed under the IRA provides for a FINAL APPROVAL with the "single response" approach. No need for a Phase 4 / post marketing surveillance study with this "new" FDA approach.

[Noteable]

ONCY's multiple clinical trials are demonstrating that ONCY's platform drug in pelareorep is able to turn cold tumors "hot" with the advantage of overcoming T-cell exhaustion, as discussed earlier.

[Noteable]

Multiple pelareorep clinical trials have demonstrated that pelareorep is safe and well-tolerated even in multiple doses, either alone or in combination with chemotherapy or multiple I/O agents.

[Noteable]

Zynyz is a checkpoint inhibitor immunotherapy that targets PD-1. Its approval marks the eight checkpoint inhibitor to hit the market and the third indicated for metastatic MCC, joining Merck & Co.’s PD-1 inhibitor Keytruda and Pfizer and Merck KGaA’s PD-L1 directed Bavencio.  The approval was based on data from the POD1UM-201 trial, a single-arm study that tested the drug in adult

[Noteable]

Repost - Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of abbreviated new drug applications (ANDAs) or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition

[Quentin30]

yup, but like you state, they need approval first..!  So from 2028, another entity could combines pela + their own CPI, have a biomarker in place, and if they were to beat ONCY to the finish line... well, they would have the exclusivity.. lol... too funny really... 

[Noteable]

ONCY's acquirer will file for the Phase 3 and request for an Accelerated Approval well before any Phase 3 PFS or OS readings become public.