Drug Develoment Is An Entrepreneurial Pursuit
Drug development, at its core, is an entrepreneurial pursuit. Uncertainty is inherent in the process, creativity and flexibility are requirements for success, and above all the sponsor must be willing to take a tremendous amount of risk with the belief that they can beat the odds and be successful. These are characteristics of entrepreneurs, not large organizations that are inherently inefficient due to the process and bureaucracy necessary for them to operate.
Aerial BioPharma LLC is different. We are a group of entrepreneurs who have come together to change the way investors and industry think about drug development. Aerial is a privately held biopharmaceutical company focused on developing biologics and small molecules for conditions that are affected by processes in the Central Nervous System. The company was founded in January of 2011 by the management team from Neuronex Inc. and Addrenex Pharmaceuticals, both successful start-ups based in the Research Triangle Park area of North Carolina. Neuronex is an on-going drug development company with a lead product to treat epilepsy. Addrenex Pharmaceuticals was a successful start-up specialty pharmaceutical company acquired by Shionogi Pharma in November of 2009.
Our expertise is drug development. Whether we are developing a reformulated product or a new chemical entity, the management team at Aerial is expert in both identifying regulatory strategies to expedite the path to approval and the efficient implementation of the clinical programs themselves. We coordinate with the FDA (and other regulatory bodies) early and often to gain agreement on the development programs for our products, minimizing surprises and speeding implementation. The success of our strategy is evidenced by the FDA approval of two NDAs, for 3 indications, over the last 4 years and the successful filing of several INDs that were cleared to proceed with no restrictions by FDA.
Our strategy is simple – identify products for our pipeline that we can expedite through the drug development process while minimizing the regulatory and technical risk associated with the program. The licensing strategy for Aerial is consistent with our previous businesses and the products we identify have to fulfill the following criteria:
- offer an improvement to patient care that is both clinically and commercially relevant
- have a clear regulatory and development pathway
- have a development milestone leading to a significant valuation inflection point that is near term (inside of 4 years from license)