Home Infusion Program

Home Infusion Development Program

Our home infusion development program

Rockwell Medical has initiated a clinical development program with FPC for the treatment of iron deficiency anemia (IDA) in the home infusion setting. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. Home infusion represents a large and rapidly growing segment of healthcare where we believe FPC may have distinct advantages and improve the treatment standard, helping to meet this very addressable yet unmet clinical need.

Our Phase II study will be the first ever randomized controlled trial of parenteral iron in the home infusion setting.

Rockwell medical poised to meet substantial unmet need in growing home infusion market.

The COVID-19 pandemic has had a major effect on our lives and has altered the world immeasurably. In particular, it has changed the way we access our healthcare. While millions of Americans were contracting the virus in the US, millions of others began...

Russel Ellison

Russell Ellison, M.D., M.Sc.
President CEO
Rockwell Medical, Inc

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Home and specialty infusion has grown by 400% from 2010-2019 representing 3.2M patients treated annually (1). IDA is estimated to occur in 40-55% of long-term parenteral nutrition home infusion patients (2), and other subgroups of home infusion patients are also at risk of IDA. Limitations of current IDA home infusion therapies and lack of a standard approach result in a significant unmet need. Home infusion-IDA total US market opportunity valued at up to $600M. Ferric pyrophosphate citrate is in clinical development to be studied in the first ever RCT of IV iron in the home infusion setting. References: 1. NHIA Infusion Industry Trends Report 2020. 2. Hwa YL, Rashtak S, Kelly DG, and Murray JA. Iron Deficiency in Long-Term Parenteral Nutrition Therapy. JPEN J Parenter Enteral Nutr. 2016;40(6):869-76.

Home and specialty infusion has grown by 400% from 2010-2019 representing 3.2M patients treated annually (1). IDA is estimated to occur in 40-55% of long-term parenteral nutrition home infusion patients (2), and other subgroups of home infusion patients are also at risk of IDA. Limitations of current IDA home infusion therapies and lack of a standard approach result in a significant unmet need. Home infusion-IDA total US market opportunity valued at up to $600M. Ferric pyrophosphate citrate is in clinical development to be studied in the first ever RCT of IV iron in the home infusion setting. References: 1. NHIA Infusion Industry Trends Report 2020. 2. Hwa YL, Rashtak S, Kelly DG, and Murray JA. Iron Deficiency in Long-Term Parenteral Nutrition Therapy. JPEN J Parenter Enteral Nutr. 2016;40(6):869-76.

Home infusion therapy is rapidly growing

The home and specialty infusion marketplace is experiencing rapid growth and provides a favorable reimbursement opportunity for suitable drugs. The number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019.REF

The home infusion setting is expected to continue this rapid expansion, which has been further supported in the COVID-19 environment.

IDA is Common Comorbidity

Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns are inadequate for patients on home infusion therapy with IDA. Iron deficiency anemia is also a condition that, if left untreated, is associated with extreme fatigue and can result in serious health risks such as poor immune function and heart failure.

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Treatments are limited

IV iron supplementation is more effective than oral formulations for treatment of moderate to severe IDA, however, concern for adverse events is a deterrent. Home infusion of traditional macromolecular IV iron is limited due to the risk of hypersensitivity and need for medical supervision of the injection and concerns about incompatibility with other infused drugs.

An office visit for infusion of IV iron is costly, inconvenient, and often does not fit the physician practice care model. Limitations with the current approach can lead to a vicious cycle of late diagnosis and treatment, inconsistent follow-up, and increased risk of office visits or hospitalizations.

Ferric Pyrophosphate Citrate May Be Uniquely Suited for Home Infusion

Based on our data on use of FPC as an anemia treatment for hemodialysis patients, FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.

Our clinical development program is underway

We have initiated a development program which includes plans to conduct a Phase 2 clinical study of FPC for the treatment of iron deficiency anemia in home infusion patients.

Phase II Complete - Clinical Feasibility. Phase II Planned - Dose Scheduling Study. Phase III Planned - Program.

Phase II Complete - Clinical Feasibility. Phase II Planned - Dose Scheduling Study. Phase III Planned - Program.