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, dosage…)
Regulatory bodies treat drug cocrystals exactly as the pure drug:
- Drug substance has new physical properties only – 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
Nuformix’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.