RE:RE:RE:RE:PwC sees continuation of US$ 5 to 15 Billion Bio M&A DealsApril 24, 2024 - Roche cull - Roche R&D rethink cut 20% of new molecules as cancer candidates ..."The drugmaker needs to terminate some programs to free up cash to invest in accelerating “a number of projects that have a high likelihood to succeed and have a huge patient impact,” Schinecker said. "
It would seem that Roche is looking to raise cash by cutting a significant portion of their small molecule R&D portfoilo, and in turn seeking to advance its large molecule product portfolio through putative M&A initiatives in the biologics space. Roche's move to cut small molecule R&D appears to have been initiated by the recent changes in international regulatory policies that give novel biologics that treat "orphan" diseases and those with "unmet treatment needs" favorable treatment, with 12 years of marketing exclusivity in the EU & UK and 13 years of similar exclusivity in the United States. In contrast small molecules would be provided with 9 years of exclusivity in the United States, while the EU & UK would offer small molecules 8 years of exclusivity.
In addition the changes in international regulatory policies preclude the "greening" Big Pharma's small molecule portfolio, as had been the conventional practice of small molecule life cycle management, which led to portfolio extention through "me-too-drugs" at the expense of innovation and the development of novel drug therapies, like immuno-oncology and the biomarker-driven combination of synergistic I/O combination thrapies, like ONCY's pelareorep in combination with immune checkpoint inhibitors, CAR-T therapy, TiLs, bispecifics, ADCs, small molecules like PARP & CDK4/6 inhibitors, and predictive diagnostics.
https://www.fiercebiotech.com/biotech/roches-pipeline-rethink-hits-20-new-molecules-cancer-candidates-join-discard-pile