Development and Commercialization Strategy
Citius Pharmaceuticals seeks to build a successful pharmaceutical company through the development and commercialization of innovative and cost-effective products that address unmet medical needs. Citius seeks to leverage the FDA’s 505(b)(2) pathway for new drug approvals and bring products to market faster and with lower cost than other FDA new drug approval pathways.
Development and Commercialization Objectives
Identify later-stage drug candidates that can be developed within a 3-4 year time horizon using a 505(b)(2) pathway.
FDA’s 505(b)(2) Approval Pathway
The 505(b)(2) New Drug Application (NDA) is one of three US Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many applicants. 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; this 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 data 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. There are compelling commercial benefits to employing the 505(b)(2) regulatory strategy, including the availability of three years of market exclusivity. Depending on the extent of the changes to the previously-approved drug and the type of clinical data included in the NDA, the FDA may also grant other forms of exclusivity and orphan drug status.
FDA’s Device Approval Pathways
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating devices sold in the United States. Medical devices are classified as Class I, II, and III. Regulatory control increases from Class I to Class III, with devices classified based on the risk to the patient. The device classification regulation defines the regulatory requirements for a general device type.
Some Class I and most Class II devices require a 510(k), in which the sponsor must demonstrate the new device to be “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.
A Premarket Approval (PMA) application is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use.
Products requiring PMAs are Class III, high-risk devices that pose a significant risk of illness or injury, or devices found to be not substantially equivalent to Class I and II predicate devices through the 510(k) process. The PMA process is more involved, and requires the submission of clinical data to support claims made for the device.
De Novo provides a means for a new device, without a valid predicate, to be classified Class I or II if it meets certain criteria.
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA application or a Premarket Notification 510(k) submission to FDA. Clinical studies of devices with significant risk must be approved by the FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of nonsignificant risk must be approved only by the IRB before the study can begin.