Developing a unique new chemical entity typically takes between 10 and 15 years, and if successful, may cost between $1 to $2 billion from discovery through final approval.
This time-consuming and expensive process presents considerable risks to pharma companies and their investors since most molecules under development never reach final approval.
New Therapeutic Entities (NTEs) represent an alternative that is faster, and far less risky. NTEs are based on known/approved molecules with established safety and toxicology profiles. These pharmaceutical actives have already completed the extremely expensive, time consuming R&D and approval process.
NTEs represent a relatively low-risk fast-track for generating specialty pharma products that are formulated, delivered or used in a novel way to address a specific unmet patient need.
By repurposing an approved drug, the time to market is significantly shortened due to the abbreviated trial and approval protocols required for NTEs.
The risk return profile of an NTE is extremely attractive because it utilizes an existing molecule whose long development, testing and approval are already completed. This places the NTE on a shorter regulatory 505(b)(2) route in the U.S., so that it can be repurposed to meet a specific unmet medical need. The shortened development timeline and faster time-to-market reduces the cost and maximizes the potential for high returns on investment.
RDD is exclusively focused on developing products that:
Molecules currently under development at RDD are expected to reach the market in two to six years. RDD is targeting an attractive space between generics and New Chemical Entities with relatively low-risk and development costs.
Safer investment and faster to market by leveraging New Therapeutic Entities (NTEs) based on approved molecules with established safety and toxicity profiles.