On a conference call last week, Keryx executives said Zerenex's patent estate is strong but issue of the drug's NCE status was not brought up. Like Amarin, Keryx is expected to seek either a partner to help sell Zerenex once approved or seek a buyer for the company outright.
JMP Securities analyst Jason Butler came to Keryx's defense Monday. "While we acknowledge that this issue [NCE status] may remain a topic of debate this week, our initial view is that it is chemically distinct from ferric ammonium citrate, and we maintain our view that currently issued patents will provide marketing exclusivity at least through 2022... Our view is that Zerenex qualifies as a NCE and will receive five years of marketing exclusivity in the U.S. and the issued method-of-use patent (U.S. 5,753,706) will be eligible to receive up to five years of patent term extension. As such, we are confident that Zerenex will have patient protection up to February 2022. Furthermore, we view the demonstration in the long-term Phase III trial of ESA and IV iron reductions with Zerenex as a novel and unexpected finding and anticipate that there may be an opportunity to build further patent protection around these data."
On Friday, an institutional investor long Keryx shares called the IPD report "bogus" and said his due diligence checks left him confident that Zerenex was eligible for NCE status.
Interestingly, another investor, more bearish on Keryx and skeptical about Zerenex's commercial potential, agreed, saying the NCE concern was overblown.
-- Reported by Adam Feuerstein in Boston.