Oncolytics Biotech Inc T.ONC

EU Legislative proposals aims to expedite new medicines

[Noteable]

Implementation of the European Commission’s legislative proposals — Regulation 2023/0131 and Directive 2023/0132 — to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children), announced on April 26, 2023, aims to reduce costs, expedite the introduction of new medicines, and prevent medicine shortages. The legislative proposals have been under consideration by the European Parliament. On March 19, 2024, the European Parliament’s Committee on Environment, Public Health and Food Safety adopted its position on the proposals, which include a number of amendments to the original proposals.

The European Parliament adopted the amended proposals during a session on April 10 and 11, 2024. Orphan drugs (medicines developed to treat rare diseases), like ONCY's platform drug pelareorep, would benefit from up to 11 years of market exclusivity if they address a "high unmet medical need", as ONCY's pelareorep does. Companies are also eligible for an additional 2 years of market protection, if their product an "unmet need" and if a significant part of the product's R&D takes place in the EU involving EU research entities, which ONCY has been accomplishing in partnership with Germany's AIO, a leading academic cooperative medical oncology group, based in Hamburg Germany. 

https://www.europarl.europa.eu/news/en/press-room/20240408IPR20308/parliament-adopts-its-position-on-eu-pharmaceutical-reform

https://www.newswire.ca/news-releases/oncolytics-biotech-r-collaborates-with-roche-and-aio-to-initiate-a-phase-1-2-gastrointestinal-cancer-trial-combining-pelareorep-with-roche-s-anti-pd-l1-checkpoint-inhibitor-800668062.html

The newly adopted European parliament proposals now has the EU offering up to 13 years of market exclusivity for new medicines that address Orphan diseases and diseases with "unment treatment needs",  equivalent to what is offered in the United States.

In the United States, Orphan drugs and biologics, like ONCY's pelareorep, are now granted 13 years of FDA market exclusivity from the date of market approval under the recently passed Inflation Reduction Act (IRA) of 2022.

And now that both the EU and the USA have passed legislation for the expedited introduction and extended 13 years of market exclusivity of new medicines that addresses "unment treatment needs" and Orphan diseases, ONCY is in an even more favorable position to be acquired by either Roche, Pfizer, Merck (MSD), Merck KGaA, Incyte, or any other Big Pharma company which is seeking to enhance theri product portfolios with a complementary product such as pelareorep, that can be synergistically combined with PD-(L)1 immune checkpoint inhibitors, bispecifics, antibody drug conjugates (ADCs), CAR-T therapies, or small molecules such as PARP and CDK4/6 inhibitors, for example.