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There were definitely some good parts in what Keryx Biopharmaceuticals (NASDAQ:KERX) had to say at this week's Stifel Nicolaus Weisel Healthcare Conference in Boston. A lot was said, but here are the three highlights you'll want to know about.
1. Commercialization of Zerenex
Keryx submitted its New Drug Application, or NDA, for Zerenex in August for treating hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis. While the company is waiting to find out whether the NDA has been accepted, most expect that it will. If so, the U.S. Food and Drug Administration should announce a decision on the drug by the third quarter of 2014.
In the meantime, Keryx is taking a two-pronged approach. CEO Ron Bentsur said that the company is having "good development dialogue." By that, he undoubtedly means that Keryx is in the middle of conversations with possible commercialization partners for Zerenex. Bentsur didn't mention any names, though.
It's not really necessary that Keryx find a partner for the initial hyperphosphatemia indication. Bentsur said he didn't see any issues with Keryx marketing Zerenex on its own. He noted that the dialysis market is fairly small and that probably only 10 to 15 sales staff would be required to be effective. My take from his comments was that going solo would be the path for initial commercialization, but that they'd really like to find a partner for the broader pre-dialysis CKD market.
2. Fending off rivals
There have been some concerns about how well Keryx will be able to protect Zerenex from competition. Bentsur tackled this issue from two angles.
First, he pointed out that establishing bioequivalence would be a challenging proposition for any potential generic challenger. Bentsur referenced Eli Lilly's (NYSE:LLY) Vancomycin as an example. While the antibiotic drug is quite different from Zerenex, he noted that for both "most of the action ocurrs in the gut" and presents some hurdles for generic developers. With Vancomycin, Bentsur said, there were no generic challengers for around 10 years.
His second line of defense related to patent protection for Zerenex. Bentsur maintained that Keryx has a compelling case for obtaining New Chemical Entity, or NCE, status. And he said that if they get NCE designation, they shouldn't have any problems getting patent extensions. At issue is whether Zerenex's active ingredient, ferric citrate, is a salt of ferric ammonium citrate, the active ingredient in Japanese drugmaker Otsuka's Ferriseltz.
3. Expectations for pre-dialysis CKD study
The big prize for Keryx is in going after the pre-dialysis CKD market. Zerenex is in a phase 2 study currently, with initial results expected to be announced in November.
Bentsur said that he expects that percentage increases of ferritin (a protein that stores iron and releases it gradually) from the phase 2 study will be comparable to what was achieved in the phase 3 study for patients on dialysis, although the baselines will be very different.
Keryx fully realizes that change in phosphate levels only won't be an acceptable primary endpoint for any phase 3 study for the broader indication. Bentsur suggested that improvement in hemoglobin levels plus phosphate levels could be the path that Keryx will take for approval.
I suspect that several companies were carefully monitoring what Keryx had to say this week. Sanofi (NASDAQ:SNY) could be one of them. Zerenex will compete head-to-head against its(NASDAQ:SNY) Renvela. The French company's drug requires more intravenous iron and erythropoiesis-stimulating agents than Zerenex, so that could give a leg up to Keryx in the marketplace.
Impax Laboratories (NASDAQ:IPXL) could be watching more closely than Sanofi. The two companies reached a deal last year that allows Impax to begin marketing a generic version of Renvela in 2014. If approved, Zerenex could take away some of the profits that Impax expected to gain.
Amgen (NASDAQ:AMGN) is another company that's probably keeping track of what's going on. The more successful Keryx is with Zerenex, the fewer possible sales for Amgen's Epogen.
Investors should probably also keep a close eye on Keryx. The stock has soared over the last year. With a few good bounces, it could climb even higher. In the meantime, the Fool will keep on being your Keryx "TiVo" to keep you up to speed.