RE:RE:RE:Inflation Reduction Act (IRA) boosts biological drugs The IRA’s favorable position is on new large-molecule biologics compared to small-molecule drugs. Provisions allow the former 13 years of immunity from mandated price negotiations, while setting a nine-year exemption period for the latter.
“It’s likely to tilt the M&A surge toward large-molecule drugs. What that could translate to is a very real strategic shift in pipelines toward biologics,” Michael Abrams, managing partner, Numerof & Associates tells Pharm Exec. “The legislation has effectively raised the risk and shortened the timeframe where manufacturers can hope to recruit their investment in any new medicine.”
The IRA, having passed in law in 2022, gives a biologic, like ONCY's pelareorep, 13 years of market exclusivity from the date of FDA product approval. - REGARDLESS OF PATENT STATUS.
ONCY's pelareorep is a "platform drug therapy" that can be used in multiple cancers, most currently in pancreatic, breast, anal, and colon cancer, with the potential of ovarian, glioblastoma and other GI cancers.
With the passing of the IRA into law in 2022. biologics like ONCY's platform drug pelareorep will gain 13 years of FDA market exclusivity in each new indication, startring from the date of regulatory approval. Each BLA will driven by the accelerated approval process - effectively granting marketing approval after Phase 2 studies and shorting the overall final approval process.
Rachel Sachs, a law professor and drug pricing expert at Washinton University, in St Louis, noted that the IRA will exempt certain drugs (Orphan.Rare drugs) from pricing negotiations, and may encourage drug companies to develop more novel products and new combinations of products to benefit from this new opportunity.
Besides ONCY's pelareorep being a "platform drug therapy" for use in multiple cancers, pelareorp has been granted Orphan Drug Status in multiple cancers including pancreatic, ovarian and fallopian tube, peritoneal, gastric, and malignant gliomas, for example.
As a result of the IRA ONCY would likely choose the "Orphan Drug" Accelerated Approval pathway foo pelareorep in the pancreatic cancer indications - and the "unmet treatment need" Accelerated Approval pathway for the rest of the indictions that pelareorep would seek approval in.
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-inc-announces-receipt-of-orphan-drug-designation-from-the-u-s-fda-for-cancer-of-the-fallopian-tube/
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-inc-announces-receipt-of-orphan-drug-designation-from-the-u-s-fda-for-gastric-cancer/
https://finance.yahoo.com/news/oncolytics-reolysin-gets-one-more-192007897.html