Nuformix uses cocrystal technology to re-engineer the crystalline form of drugs.

The vast majority of drug substances possess physical properties that are far from ideal for development as a medicine. Consequently, drug products frequently perform sub-optimally and are not always best suited to the needs of the patient or the disease.

New Intellectual Property
Drug cocrystals are eligible for new composition of matter patent protection:

  • Cocrystal patents can be granted globally, providing 20 years protection for each new form created
  • Opportunity to retrospectively secure robust and enabling IP for molecules that have lost their protection
  • Circumvent IP barriers commonly used to prevent market entry (e.g. polymorph, formulation, dosageโ€ฆ)

Regulatory Advantages
Regulatory bodies treat drug cocrystals exactly as the pure drug:

  • Drug substance has new physical properties only โ€“ its pharmacological activity is unchanged
  • Therefore, drug cocrystals are applicable globally for both generic and abbreviated approval pathways
  • US FDA Guidelines, April 2016: Cocrystals are classified as analogous to a new drug polymorph
  • EMA Guidlines, May 2015: Cocrystals are treated as the same active substance as the original drug

Reduced Risk
Nuformixโ€™s approach uses existing drug molecules, with a history of safe use:

  • No new safety data is required if staying within existing exposure limits, allowing rapid entry to both clinic and market
  • Existing clinical data better informs decision making in future development
  • Reduced time and cost of achieving clinical proof-of-concept and increasing success rates versus traditional biotech models.

2 posts were merged into an existing topic: Nuformix - NFX

A post was merged into an existing topic: Nuformix - NFX