Biocompatible Protein Encapsulation Technology
Active drug first approved by FDA in 2010 as the treatment of hormone-refractory prostate cancer, API patent expiring 2022
Revenue currently over $0.5B
Original formulation in surfactant that elicits allergic reaction and contribute to dose-limiting tox
SN-100 completed preliminary in vitro and in vivo studies demonstrating higher tolerant dose and better efficacy
Short 505b(2) pathway
Biocompatible Process Technology Platform for Protein Drug Encapsulated Nanoparticle
A novel process technology in manufacturing the albumin-drug nanoparticle
Process produces Nanoparticle with only class 3 (non-toxic) solvent
Multiple encapsulation successful with scalable process and complete analysis
Addresses the most challenging problem in NAB-paclitaxel manufacturing
Not infringing Celgene’s key patent
ZNAP
Generic version of Non-biological Complex formulation of Abraxane
Potential first in market generic version
Significantly lower cost due to the ruggedness of process and avoiding residual solvent issues
No infringement of the key patent
Short development path in 505(j)
Low risk of failure
SN-100 Improved Formulation for Prostate Cancer Treatment
Active ingredient approved by FDA as the treatment of hormone-refractory prostate cancer
API patent expiring 2022
Annual sales over $0.5B
Current formulation in surfactant that elicits allergic reaction and contribute to dose-limiting tox
SN-100 in vitro and in vivo studies demonstrated higher tolerant dose and better efficacy
Short 505b(2) pathway
Pipeline
The innovative process expended the original NAB drug encapsulating platform and made it possible for more products developed with this technology. We have tested other therapeutic molecules with delivery challenges with successful results.
We welcome inquiries for applying this technology to your drug candidates.