New iron drugs could be big winners after bundle is finalized

New iron drugs could be big winners after bundle is finalized
1/12/2010
By Thomas Keating

This article is from NN&I's January 2010 issue

Since U.S. regulators approved AMAG Pharmaceutical Inc.'s Feraheme in June, few nephrologistshave used the new drug, but they are "on the verge" of doing so, a survey re-leased Nov. 23 by BioTrends Research Group showed.

Feraheme was approved by the U.S Food and Drug Administration for intravenous use as an iron-replacement therapy for the treatment of iron deficiency in adult patients.

With the inclusion of the very ex-pensive medication Epogen (EPO) in the proposed ESRD bundled payment, dialysis providers could recommend to doctors that they prescribe lower doses of EPO to patients, and more iron drugs like Feraheme.

Only 8% of nephrologists reported using Feraheme in chronic kidney disease patients not on dialysis, the survey showed. However, two of the nephrologists in the study reported that their dialysis units now have a contract with AMAG and are getting ready to start using Feraheme; others report their dialysis units are considering using the product.

And, in addition to impacting other IV iron products, nephrologists expect Feraheme will increase their overall use of IV iron and reduce their use of ESAs, the survey showed. The desire to reduce use of ESAs is particularly high with the recent release of TREAT and the advent of bundling.

Rockwell Medical Inc.'s would-be Feraheme competitor, Soluble Ferric Pyrophosphate (SFP), completed FDA Phase 2b trials Oct. 29 and has entered into Phase 3. The company announced new data Nov. 2 at the American Society of Nephrology meeting in San Diego, and feels that SFP will fare very well with the final structure of the ESRD bundle.

"We do expect to see efforts made by providers to reduce EPO use, due to the bundled payment structure," Rob Chioini, president & CEO of Rockwell Medical, told NN&I. "We cannot predict if total iron use will increase as a result and we are not concerned about it as it relates to SFP. SFP is designed to be used in every treatment, like EPO, and we expect SFP dose frequency will reduce EPO use."

But, unlike the recently-launched Feraheme, SFP's introduction is a few years away. Based on the clinical work still scheduled to be completed, Chioini said he estimates SFP will be available commercially in 2013, provided it receives FDA market approval.

Rockwell Medical has licensed exclusive worldwide rights to manufacture and sell SFP 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. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually, while global market potential is approximately $850 million.

And with the bundle's favorable structure toward iron drugs, U.S. market potential seems likely. The bundle will have been in effect for two years by 2013. Chioini said the bundle-as it relates to SFP and Rockwell Medical-will be "a very favorable event."

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