Regulatory Pathway Assistance
RyMat Inc. provides a variety of services helping with the facilitation of a 505(b)(2) New Drug Application (NDA).
From initial concept inception, through feasibility, Pre-Ind, Formulation Development (novel drug delivery systems), through the rigors of clinical development, up through NDA submission and beyond. With access to a vast array of resources, RyMat Inc. can provide guidance and make possible the collaborations needed to realize success in this space.
Currently, the Generic Pharmaceutical Industry is experiencing “the best of times.” With many blockbuster drugs coming off patent over a relatively short period of time. Some have called this a “patent cliff.” Beginning in 2016, the Generic Pharmaceutical Industry will experience their own “patent cliff.” Relatively few big drugs losing their patent exclusivity.
So how is the Branded Pharmaceutical Industry to respond to their patent cliff and how will the Generic Pharmaceutical Industry respond to their rapidly approaching patent cliff? One of the trends in pharma (especially when considering a lack of new drugs being successfully launched) is via the “repurposing” of drugs. This is with respect to the filing known as the 505(b)(2) NDA. Among other things, filing a 505(b)(2) NDA gives the sponsor three years (or even more) of exclusivity as opposed to the 90 day exclusivity provided by a straight ANDA. As a matter of fact, 70% of all NDAs file L d in 2013 were 505(b)(2)s.
In case you are not familiar with 505(b)(2) NDAs, here is some information:
The 505(b)(2) NDA drug approval pathway represents an appealing regulatory strategy for many companies (Branded, Biotech, Generic). 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.
A company may wish to create a new dosage form that is faster acting, combines two active ingredients in a novel way, or provides a route of administration or mechanism of drug delivery that patients or doctors prefer over previous versions. Also, a company may wish to seek approval for a new indication for an already-approved drug or carry out an Rx-to-OTC switch. Such new products often contain well-understood active ingredients that are present in existing, approved drug products (reference drugs); so, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication. The 505(b)(2) NDA pathway makes this possible.
505(b)(2) is particularly valuable for pharmaceutical and generics companies looking to alleviate competitive forces in their environments while still wanting to benefit from a development process that eliminates most nonclinical studies as well as extensive safety and efficacy tests.
Our collaborations range from strategic alliances in basic research and the development of new technologies to concrete R&D projects in our core therapeutic areas or co-development and co-commercialization agreements. In the years to come, we plan to further extend our partnering activities and invest even more in collaboration and external innovation.