At the investigation stage of drug development, several tens of thousands of compounds are screened and after the most promising exploratory product is identified, safety and basic pharmacology are evaluated in non-clinical trials. Thereafter, the product is evaluated in Phase I on healthy subjects, and in Phase II and Phase III trials on patients. In the event that all studies show positive results, and the safety and efficacy is confirmed, the drug is approved. However, the probability that a compound will reach the market has in recent years been in the order of 1 in a 1,000 000, while the time necessary for the development is estimated to be 15 years with development costs more than $1 billion. At the same time, the number of drugs approved each year is decreasing.
In response to this challenging environment, Sosei established DRP® (Drug Reprofiling Platform®). This model, directed towards a lower risk approach to development, is based upon identifying new uses for existing drugs (either halted or marketed) or drug templates for which clinical development has been undertaken and the safety profile in humans confirmed. Successful examples of this approach are NVA237 (COPD), which was reprofiled from an injection drug to an inhaled therapy, and the new indication of neuropathic pain for the Sosei pipeline product SD118.
However, a bioventure company should not settle for having achieved a certain measure of success through its reprofiling method in the past. Relying indefinitely upon the same technology and business model limits corporate expansion. Sosei, therefore, decided to replenish its reprofiling platform and pursue a new growth strategy based upon the nano-technology (APNT: Activus Pure Nano-particle Technology) obtained through the August 2010 acquisition of Activus Pharma .
APNT, unlike other nano-particle processing technologies, keeps compounds virtually free from contamination. At the same time, it can yield pharmaceutical ingredients with particle size　ranging from 50 to 300nm levels. Thus, APNT enables the development of injections, ophthalmic solutions and inhalations with poorly soluble　compounds where high purity is required.
The needs for nano-particle technology within the pharmaceutical industry are still largely unmet. Therefore, the technology can be expected to generate new development candidates for Sosei, and partnership with other pharmaceutical companies will allow Sosei to realize revenue from this technology in a relatively short period of time.
