TnPharma – LAI’s (Long Acting Injectables)
TNP’s business model seeks to create value by progressing the development of SDN™ engineered actives to appoint where their clinical development can be progressed by a pharma partner through the final stages prior to launch and marketing.
Value creation comes from licencing and royalties enhanced with TNP’s development activities. The focus will be on actives that can be delivered through the FDA’s 5052(b) pathway (see Regulatory)
This pipeline will be focused on Long Acting Injectable (LAI) technologies which seek to significantly expand the therapeuutic availability of drugs that currently require frequent dosing to achieve their effect.
TNP will seek to develop candidates that take advantage of the fast track approval process in the US known as 505(b)(2)
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many companies. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved (“reference” or “listed”) drug; the section gives the FDA express permission to rely on data not developed by the NDA applicant.
A 505(b)(2) NDA contains full safety and effectiveness reports but allows at least some of the information required for NDA approval, such as safety and efficacy information on the active ingredient, to come from studies not conducted by or for the applicant. This can result in a much less expensive and much faster route to approval, compared with a traditional development path [such as 505(b)(1)], while creating new, differentiated products with tremendous commercial value.