Our ferric citrate API or drug substance is unlike any other, it has considerably higher intrinsic dissolution and surface area, which are critical for the drug product activity as compared to the OTC versions, as well as much higher purity levels. We believe that only with those characteristics can one potentially develop a tablet that will have a commercially viable amount of ferric iron in it.
All of this talk about proprietary API for a molecule that has been known for a hundred years is a smoke screen distracting from the fact that Keryx is not going to get NCE or patent term extension, leaving Keryx with a dubious manufacturing barrier to entry. Ferric citrate is not a biologic. The idea of erecting a manufacturing barrier to entry is silly. Keryx's argument in essence is "if we fail to get NCE or patent term extension, we will be able to administer six tablets per dose while our competitor requires seven."
As many of you know, New Chemical Entity, or NCE for short, is based on active moiety and is determined by the FDA. Patent Term Extension, or PTE for short, is based on active ingredient and is determined by the PTO or the Patent Office. Both determinations will be made post-approval... I cannot go into all the details on this call and we do not plan on disclosing everything for competitive and strategic reasons, but there are several things that are very important in thinking about NCE and PTE.
Keryx has a method of use patent on Zerenex that will expire in 2017. That does not leave much room for market exclusivity. Keryx has stated that they anticipate PTE may allow extension of this patent by five years. Among the six criteria for determining eligibility for PTE is a stipulation that the "applicant must show that the product either represents the first permitted commercial marketing or use of the product...". Ferric citrate is available for sale at various health food stores. In other words, Zerenex is not the first commercial sale of ferric citrate, and therefore fails to satisfy PTE requirements.
Neudexta is a recent example of a rejection of PTE by the patent office. Neudexta is a combination product of dextromethorphan and quinidine. U.S. patent officials found PTE to be unwarranted because both ingredients had previously been sold commercially. Importantly, dextromethorphan, like ferric citrate, was sold over the counter
to Neudexta's approval. Avanair subsequently appealed this case without success.