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N4 Pharma develops new versions of existing drugs that are already on the market (generics) and new delivery systems for drugs currently in development (therapeutics and vaccines). These newly reformulated drugs from N4 Pharma’s portfolio are then taken to the stage where it can license them to pharmaceutical companies for commercialisation. N4 Pharma’s revenues will be derived from advance milestone and royalty payments associated with the licences.

The company has two divisions:

Generics – Reformulation of existing generic drugs

This division initiates research and development to generate the required clinical proof-of-concept data that will lead to licensing deals with pharmaceutical companies. Such deals would typically involve upfront milestone payments and royalty payments to follow in later years. N4 Pharma outsources its research and development to minimise overheads.

The stages in this process are typically:

  1. In vitro reformulation
  2. Small scale human studies
  3. Pre-IND meeting with FDA
  4. Licensing agreement

The entire process is estimated to take three years to regulatory approval with an estimated cost between £3-5 million for pharmacokinetically bio-equivalent drugs.

Vaccines – Delivery of novel and existing vaccines and therapeutics

N4 Pharma has developed two novel delivery technologies for vaccines and biological therapeutics; Nuvec®, designed for improved delivery of DNA and RNA and a novel system to reduce the number of injections required to achieve immunity. It is undertaking the required pre-clinical work to demonstrate the capability of these delivery systems so that it can license the technology to major players developing treatments in this area. Again, this license would be in return for advance milestone and royalty payments.

The stages in this process are typically:

  1. In vitro proof of concept data
  2. In-vivo pre-clinical efficacy and toxicology
  3. Partnership collaborations to test the delivery system
  4. Licensing agreement