The European Medicines Agency (EMA) approved Fexeric with broadest possible label, for broad use, in pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with CKD. The EU Commission considered ferric citrate a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe. Furthermore, given no iron warning, some analysts project that nephrologists in EU will prescribe Fexeric considering full benefits i.e. IDA.
This was some 21/2 years ago, 21/2 YEARS AGO - incredible. This goes back to hypo scenario Keryx/AMAG/Rockwell Medical - “sequence of events...during past some 4 years and as we speak, are interrelated. In other words, Keryx’s development/true advancement as a company during past years has not been truly independent, but rather in function to some degree of AMAG and Rockwell Medical and, at the core, timeframe involved while and until generics FDA approved and launched.”
In quarterly conference calls following EU approval, 2+ years ago, Madison led shareholders to believe that the company in duscussions and actively seeking a EU partnership. The following Madison comments from 3Q2015, 4Q2015, and 1Q2016 conference calls..
_______________________________
In 3Q2015 cc, Madison’s comments were clear and straightforward..
“While it’s not provided specific timeline to our partner, and potential launch, our commercial plan is to partner in the EU, either through pan-European partnership regional partnerships.We continue to engage with potential partners to evaluate the best opportunity to make Fexeric available to the thousands of adults in Europe with chronic kidney disease or also taking new account to pricing dynamics that exist in Europe today.”
As we laid out today, the commercial strategy is to partner in the EU, either through Pan-European partnership. At this point we don’t comment on which companies nor the timing of the potential transaction, but to some extent those discussions were
ongoing”
__________________________________
In 4Q2015 cc, Madison continued clear and straightforward..
“Second, we expanded our geographic opportunity with the approval of ferric citrate in EU and are currently seeking partners to commercialize Fexeric in this region.”
Although, in Q&A session, Madison kinda changed his tune a bit..
“Regarding Europe at this point in time, I would say from a – we have looked at pan-European opportunities as well as regional based opportunities. I think we are leaning more towards our regional based approach overall, regards as you think about Europe. The European marketplace it is complex, and there is a lot of pricing pressure over there. In addition, you do have some generics development that is appeared in countries in a very limited fashion, but when you think about the European pricing model, sometimes that triggers a mandatory price discount. So, there are some countries that can [indiscernible] or less valuable than others. So, as you think about our regional base partnership approach, that’s kind of the focus we are looking at right now and our goal is to identify a potential partner and we will keep you update along the way.”
________________________________
In 1Q2016, the tune kept changing with following Holmes comments..
“In terms of Europe we continue to work with financial partners in Europe. It’s kind of taking longer than we’d like to see. At the core issue there, there’s just a lot of uncertainty today around pricing with some of the introduction of generic Renvela in certain market places.
Now we believe we have a product profile which supports pricing similar to other branded phosphate binders and so we do plan to continue our reimbursement work with our dossier, so we start at the beginning of the year and plan to continue to submit those to the pricing authorities overall in 2016.”
__________________________________
continued...
