Rockwell has the world wide rights to deliver iron in dialysate.
Phase III trial results due July
If it works, opens up major licensing opportunities world-wide for 20-25% royalties on SFP sales paid to Rockwell. 100% gross margin and all upside.
According to independent research company IMS Midas and Fresenius, the largest dialysis provider in the world, there were 2,306,000 patients on dialysis in 2012
Highly likely Rockwell keeps 100% rights for North America, which had 543,000 patients on dialysis and they all need iron. Addressable market for this region is $688 million and Rockwell keeps this all to themselves.
X North America new markets for SFP is wide open and massive, worth est'd $2.7 to 7 billion.
Europe/Middle East/Africa currently has 617,000 patients on dialysis. By 2015, this new un-tapped SFP market is worth approx $866 million. I wonder which partner will want to sell SFP in this new region?
Asia-Pacific currently has more than twice as many dialysis patients vs US with 906,000 and also growing twice as fast (9% per year every year!) due to their massive population and Governments just getting started to offer dialysis. China alone has 1.4 billion people! By 2015, this new market for SFP is worth approx $1.5 billion! If Rockwell meets its Phase III primary end point this July, which is only 2 months away, I predict that Fresenius and Baxter will fight over this region someday to sell SFP.
Japan 309,000 patients currently on dialysis. By 2015, this new un-tapped market for SFP is worth $410 million. What Japanese pharma will want the rights to sell SFP to their own captive population?
Latin America, like Asia, is just getting started offering dialysis. Now only 240,000 but growing faster than US. By 2015, this new market for SFP is est'd $356 million. Another licensing opportunity for a company with world-wide distribution is for sale if come July, SFP works
OH-, I think you are missing the new Keryx drug for hyperphosphatemia. It is an iron based phosphate binder that maintains iron stores. In long term advanced trials (PIII) it showed that a large and statistically significant portion of ESRD patients either did not require supplemental iron or required substantially fewer treatments (same was observed with ESA treatments). The results corroborated studies by a partner company in Japan who has already filed for approval and marketing. Zerenex is currently being tested in PII for CKD patients as well. As with iron, nearly all ESRD and many CKD patients require phosphate binders and in large quantities. So in one case they will get a double treatment in one (Zerenex) and in the other case (SFP) they will only be treating one component of the disease. Given that the synthesis of Zerenex is fairly simple, it will compete well on a unit cost basis with other phosphate binders on the market and even those ready for generic equivalents. So your numbers may have to be curtailed quite a bit as far as assuming that all or nearly all dialysis patients will require supplemental iron....may by 30-50%???