Developing patented new drugs for serious diseases using the 505(b)(2) regulatory pathway
GeneBiology combines deep expertise in medicine, drug development and formulation chemistry to identify, develop, and market patented new formulations/new routes of administration/new indications for approved medicines under the 505(b)(2) regulatory pathway. The 505(b)(2) pathway is the fastest, least expensive, and lowest risk regulatory pathway for development of important new drugs, because both data on file for prior approval(s) and published data can be used to fulfill regulatory requirements for both clinical development and commercial approval, thereby substantially reducing the costs (in time and money) and the risks of developing new drugs.
GeneBiology has two new patented formulations in development, one for vertigo and motion sickness and also for nausea and vomiting of any cause, and the other for breast cancer in patients who have failed tamoxifen. GeneBiology also has identified a substantial portfolio of clinically and therefore commercially important additional targets for new formulations.
GeneBiology is a privately funded corporation that began operations in 2006, and intends to remain private. Pertinent models of successful private pharmaceutical companies include the former Burroughs Wellcome Co. (where several founders/principals were privileged to learn drug development and to work with three of Wellcome’s five Nobel Prize winners in medicine) and Boerhinger Ingelheim. GeneBiology has created a 501(c)(3) foundation to benefit the University of North Carolina at Chapel Hill (where several founders/principals were fortunate enough to receive their educations) that will be funded through royalties.