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Clinical and Regulatory Strategy Our strategy initially is to demonstrate the bioequivalence of each of our emulsion formulation product candidates to the currently marketed reference product. The bioequivalence of two drugs can be demonstrated in a single clinical trial of as few as 28 patients, typically in an open-label, single-dose, cross-over comparison of the drugs. For each of ANX-530 and ANX-514, the FDA has indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of our product candidates to the reference product may be sufficient clinical data to support a Section 505(b)(2) NDA. Accordingly, we view these bioequivalence trials as registrational clinical studies in that they have the potential to support a marketing application. If approved, the drug prescribing information, or "label," for our products may reflect clinical data generated during the bioequivalence trials, including comparative adverse event information. The relatively low number of required patients and the single-dose treatment cycles associated with these bioequivalence trials can decrease study timelines and costs relative to typical pivotal studies. Accordingly, with relatively modest financial investment, we are able to assess in the clinic the pharmacokinetic equivalence of each of our product candidates to the reference product in as little as 12 to 18 months, which information should provide the clinical data necessary to support a Section 505(b)(2) NDA. By securing in advance FDA agreement regarding our planned regulatory pathway, as we have done for ANX-530 and ANX-514, we mitigate aspects of the clinical and regulatory risk associated with drug development. Furthermore, if and after we obtain marketing approval, we can conduct additional clinical studies while marketing our products for use of these products in new indications or to expand product labels in ways that might increase their commercial value. Furthermore, if any new clinical studies we conduct, in addition to our bioequivalence studies, are essential to the FDA's approval of an application to use our products or product candidates to treat a new indication, or to support a label change in product use, the product may be eligible for three years of marketing exclusivity for that indication or use. Marketing exclusivity means that the FDA will not approve an abbreviated NDA, or ANDA (an ANDA is for a generic drug product) or Section 505(b)(2) NDA during the exclusivity period based on the conditions of approval of our product. |
