pIPELINE
RARE DISORDERS AND INFECTIOnS DISEAsESPharmaceutical Product Pipeline
Revive is building a pharmaceutical product portfolio targeting rare disorders and infectious diseases.
PHARMACEUTICAL STRATEGY
Clinical development of Psilocybin, Cannabidiol and Bucillamine
targeting rare disorders and infectious diseases
novel Uses, formulations and delivery system
targeting FDA designations: Orphan, Fast track, breakthrough therapy and rare pediatric diseases
FORMULATION & DELIVERY TECHNOLOGY
- Delivering naturally extracted and synthetic psilocybin and cannabinoids
- PSILOCYBIN – Prescise dosed formulations i.e. capsules, sublingual spray, gel caps, effervescent tablets and oral/transmucosal strips
- Releases (rapid, controlled, sustained), improved bioavailability, no first-pass etabolism
- CANNABIDIOL – Novel combination of composites allowing for multiple delivery formats, potential synergistic and therapeutic effects
- Tannin (plant-based) – antibacterial, antifungal, antioxidant and wound healing
- Chistosan (shrimp-based) – blood-clotting and antimicrobial properties
PRODUCT PIPELINE
Focus on Infectious Diseases, including COVID-19, AND Rare disorders
Product
Bucillamine
Indication
Infectious Diseases
(Covid-19)
Stage of Development
Filling IND
Regulatory Status
Received FDA
Orphan Status
Market
TBD
Product
CBD
Indication
Liver Diseases
(Autoimmune Hepatitis)
Stage of Development
Filling IND
Regulatory Status
Received FDA
Orphan Status
Market
+ $100M
50k US Pop
Product
Psilocybin
Indication
Undisclosed
Stage of Development
Pre-Clinical
Regulatory Status
Target FDA
Orphan Status
Market
+ $500M
Product
Psilocybin
Indication
Undisclosed Mulitple Indications
Stage of Development
Pre-Clinical
Regulatory Status
Target FDA
Orphan Status
Market
TBD
Bucillamine
Infectious Diseases
(COVID-19)
Filing IND
Received FDA
Orphan Status
TBD
Bucillamine
Liver Diseases
(Autoimmune Hepatitis)
Filing IND
Received FDA
Orphan Status
+ $100M
50K US Pop
Psilocybin
Undisclosed
Pre-Clinical
Target FDA
Orphan Status
+ $500M
Psilocybin
Undisclosed Multiple Indications
Pre-Clinical
Target FDA
Orphan Status
TBD
As for its rare disease pharmaceutical product pipeline, Revive has been granted by the U.S. Food and Drug Administration (“FDA”) two orphan drug designations for cannabidiol (“CBD”) in the treatment of autoimmune hepatitis, a rare liver disease, and CBD in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation, such as liver, kidney, heart and lung.
Revive aims to build a portfolio of FDA orphan drug designations of cannabinoids that are complementary to Revive’s cannabis-based pharmaceuticals initiatives that support the long-term potential of cannabinoid prescription medicines for rare diseases and disorders, which the Company believes has been validated by the FDA approval of the GW Pharmaceuticals plc EPIDIOLEX®.