Earlier clinical trials demonstrated that SFP, delivered during each dialysis treatment via dialysate, maintained optimal iron balance and had an excellent safety profile. Maintenance of iron improves the therapeutic response to ESA and decreases ESA doses needed to maintain hemoglobin in a target range in the body.
The first of Rockwell’s two Phase 3 CRUISE studies will be completed in May of 2013, and the second in August. Mr. Chioini says the plan is to report data in October, file a new drug application before the end of 2013 and hopefully, be on the market during the second half of 2014.
Many dialysis providers are participating in the two pivotal trials. “If we get approval, we believe dialysis providers will use SFP because they will have had two years of experience with it and will have seen its benefit in their patients,” Mr. Chioini says.
The company also expects to report data in the first quarter of 2013 from its PRIME marketing study, which is designed to demonstrate the reduction of ESA in SFP-treated patients versus IV iron. “If we can reduce ESA by 1% to 2%, that would be significant,” Mr. Chioini says.
In a recent report, Annabel Samimy, an analyst with Stifel Nicolaus, said positive PRIME data would represent a “transformational milestone for Rockwell because it [would] enable Rockwell to price SFP at a significant premium. If SFP shows 10% ESA-sparing, SFP can theoretically save about $700 per patient per year in costs of ESA, assuming an annual EPO cost of $7,000. Of that $700, Rockwell [could] share the savings with dialysis centers, resulting in improved SFP margins well above 90%.”