In addition to physical property improvement and performance differentiation, cocrystal technology provides important strategic benefits when developing new therapies based on known drugs.
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
Benefits of reduced development risk/cost and speed to clinic/market are retained with new IP and significant differentiation in place.