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Regulatory Strategy The regulatory strategy for our lead product candidates, ANX-530 (vinorelbine injectable emulsion), or Exelbine™, and ANX-514 (docetaxel lyophilized emulsion for injection), is to demonstrate the bioequivalence of each to the currently marketed reference product. The bioequivalence of two drugs can be demonstrated in a single trial of as few as 28 patients, typically in an open-label, single-dose, cross-over comparison of the drugs. For each of Exelbine 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 new drug application, or NDA, under Section 505(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Accordingly, we view these bioequivalence trials as registrational studies in that they have the potential to support a marketing application. If approved, the drug prescribing information, or "label," for our products generally will be the same as for the reference product, but may reflect differences between our product candidate and the reference product (such as, for ANX-514, the absence of detergent in our formulation) or data generated during the bioequivalence trials, including comparative adverse event information. Ultimately, because the label for our product candidates, if approved, will be based on discussions with the FDA, we cannot predict with accuracy the final label of a product candidate, should any be approved. 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 modest financial investment relative to traditional development of new chemical entities, we are able to assess the pharmacokinetic equivalence of each of our product candidates to the reference product in as little as 12 to 18 months from the initiation of the trial, which information should provide the data necessary to support a Section 505(b)(2) NDA. By securing in advance clarity from the FDA regarding our planned regulatory pathway, as we have done for Exelbine and as we intend to reconfirm for ANX-514, we mitigate aspects of the regulatory risk associated with drug development. Furthermore, after we obtain marketing approval, we can conduct clinical studies while marketing our products to expand product labels in ways that might increase their commercial value. Furthermore, if any 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. |
