-New indications for FPC platform provide significant growth opportunity-
-Anticipates Type C meeting with FDA for home infusion in Q1 2021 and for acute heart failure in 2H 2021-
-Well capitalized to fund dialysis business and advance clinical development for home infusion indication-
-Archived webcast available on corporate website-
WIXOM, Mich., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, earlier today concluded its Management and Key Opinion Leader (KOL) conference call and webcast to discuss potential novel indications for its ferric pyrophosphate citrate (FPC) platform. The conference call included presentations by Rockwell Medical executive management and Connie Sullivan, B.S. Pharm., President and CEO of the National Home Infusion Association, and Inder Anand, M.D., F.R.C.P., D.Phil. (Oxon), Emeritus Professor of Medicine at the University of Minnesota Medical School and Former Director of the Heart Failure Program at VA Medical Center in Minneapolis.
“Earlier today, Rockwell Medical and independent leading experts laid out the pathway for potential important value creation for the Company through the development of the FPC platform to treat medical conditions with unmet clinical needs outside of the hemodialysis setting. This exciting new development plan for FPC, along with increasing adoption of Triferic for dialysis patients, are evidence of Rockwell Medical’s continued focus on our vision – to transform the treatment of iron deficiency and anemia for the millions of people affected worldwide,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “FPC for the treatment of iron deficiency anemia (IDA) in home infusion patients is our top development priority, which we view as a tractable clinical development project with relatively low safety risk given our extensive safety database of FPC, and low efficacy risk given our expertise and experience in the use of parenteral iron for the treatment of IDA. We expect to hold a Type C meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 to discuss the program further. We are well capitalized to fund our existing dialysis business and advance clinical development for a home infusion indication, and we expect opportunities for multiple data read-outs and milestone reports from the home infusion program over the next three years as we advance the program through Phase II clinical proof-of-concept development.”
Dr. Ellison added: “In addition, we discussed potentially pursuing an indication for FPC in hospitalized patients with acute heart failure. We believe FPC could be uniquely suited for these patients, based upon a completed mechanistic proof-of-concept study and the immediately bioavailable iron that FPC can deliver to patients during a short hospital stay. We continue to evaluate this opportunity and anticipate holding a Type C meeting with the FDA in the second half of 2021 to discuss the pathway for a potential clinical development program.”
Highlights from the conference call and webcast are as follows:
Home Infusion
- Home infusion therapy is a rapidly growing area of medicine, with over 3.2 million patients served in 2019. We believe the growth trend is likely to continue driven by cost savings versus office-based or hospital care, an improving reimbursement landscape, and emerging standards resulting from the COVID-19 pandemic.
- IDA is a common co-morbidity in many sub-groups of patients receiving home infusion therapy, particularly in those receiving long-term home parenteral nutrition (HPN).
- Management of IDA in home infusion patients is currently a ‘broken’ process, according to the National Home Infusion Association, due to limitations with currently available parenteral iron products and other factors.
- FPC is uniquely suited for the treatment of IDA in the home infusion population based upon its kinetic profile and outstanding safety profile in both clinical trials and post-marketing use, and may fill an unmet clinical need as a uniquely suitable home infusion therapy for treatment of IDA.
- Home infusion therapy patients with IDA may be candidates for treatment with FPC across additional therapeutic categories besides HPN. These categories include antineoplastic chemotherapy, hydration therapy, inotropics and biologics. The U.S. market opportunity for HPN is estimated to be $200 million per year, and the U.S. market opportunity for the other categories above is estimated to be $400 million per year.
- The majority of home infusion therapy patients are covered by commercial insurance, and payers are increasingly motivated to reimburse home infusions to reduce in-office visits and hospitalizations, and save costs.
- Rockwell Medical intends to hold a Type C meeting with the FDA in Q1 2021 to discuss the pathway for clinical development. The Company anticipates conducting a Phase II observational study and a dose scheduling study to achieve proof-of-concept, with the goal of ultimately securing a broad label claim of treatment of IDA in adult patients receiving home infusion therapy regardless of etiology.
- The Company expects Phase II data around the end of 2021.
Acute Heart Failure
- Heart failure (HF) in the U.S. is a large and growing patient population. More than one million patients are hospitalized each year with acute decompensated heart failure, and iron deficiency (ID) is a common co-morbidity in all forms of HF.
- The acute heart failure (AHF) opportunity for FPC is associated with a large patient population with a high incidence of iron deficiency. FPC has theoretical acute clinical advantages (