Biotech Values

[apljack]

AMAG: I've another question, about the utility of IV iron vs. infusion via dialysate (being developed by Rockwell Medical Technologies, RMTI; see PR below). Does anyone know which would be preferred by the nephrologist treating the anemic ESRD patient? The side effect profile of SFP appears to be lower than what one would expect using an IV, xrymd.

http://finance.yahoo.com/news/Rockwell-Medical-Technologies-pz-15066407.html?x=1

WIXOM, Mich., April 29, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (NasdaqGM:RMTI - News), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that patient enrollment has been completed for it's ongoing Phase 2b dose-ranging study for its iron deficiency anemia drug soluble ferric pyrophosphate (SFP). "We are pleased to have achieved this important milestone following two positive safety reviews from the data safety monitoring board (DSMB). We anticipate having study data available in the fourth quarter of 2009 and shortly thereafter commencing our Phase 3 program," stated Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell Medical.

The Phase 2b dose-ranging study is a six-month, controlled multi-center, double-blind study consisting of approximately 130 hemodialysis patients at multiple dialysis centers in the United States and Canada. Subjects are randomized to receive one of several concentrations of SFP or placebo in dialysate during their normal three times/week dialysis regimen. The primary objectives of the study are to evaluate both safety and efficacy of SFP at varying dose levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range.

About SFP:

SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.