N4 Pharma’s business model is to take reformulated drugs from its portfolio through to the stage where it will license its newly reformulated drugs to pharmaceutical companies to commercialise them. N4 Pharma’s revenues will be derived from up front milestone and royalty payments associated with the licence.
The stages in this process are typically:
- In-vitro reformulation
- Small scale human studies
- Pre-IND clearance from FDA
- Licensing agreement
The whole process is estimated to take three years to regulatory approval with an estimated cost between £3-5 million for pharmacokinetically bio-equivalent drugs.