Rockwell Medical Submits Investigational New Drug Application with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion
November 11 2021 - 8:30AM
Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical
company dedicated to transforming the treatment of iron deficiency
and anemia management and improving outcomes for patients around
the world, today announced that it has submitted an Investigational
New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) in support of its proposed Phase 2
clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for
the treatment of iron deficiency anemia and maintenance of
hemoglobin in patients receiving infusion therapy in the home
setting.
“Home infusion represents a large and rapidly
growing segment of healthcare. Many patient groups requiring home
infusion therapies suffer from chronic diseases that are associated
with a high incidence of iron deficiency and anemia,” said Marc
Hoffman, M.D., Chief Medical Officer of Rockwell Medical. “Current
treatment patterns can be inadequate for patients on home infusion
therapy with iron deficiency anemia, causing them to suffer extreme
fatigue, and can result in serious health risks.”
“We are very pleased to have achieved another
development milestone with the submission of this IND for our FPC
home infusion program as we expand our efforts to develop FPC
outside of dialysis,” said Russell Ellison, M.D., President
and Chief Executive Officer of Rockwell Medical.
Once the IND is submitted, a sponsor must wait
30 calendar days before initiating any clinical trials. During this
time, FDA has an opportunity to review the IND.
About Rockwell Medical
Rockwell Medical is a commercial-stage biopharmaceutical company
developing and commercializing its next-generation parenteral iron
technology platform, Ferric Pyrophosphate Citrate (FPC), which
has the potential to lead transformative treatments for iron
deficiency in multiple disease states, reduce healthcare costs and
improve patients’ lives. The Company has two FDA-approved therapies
indicated for patients undergoing hemodialysis, which are the first
two products developed from the FPC platform. Rockwell Medical is
also advancing its FPC platform by developing FPC for the treatment
of iron deficiency anemia in patients outside of dialysis, who are
receiving intravenous medications in the home infusion setting. In
addition, Rockwell Medical is one of two major suppliers of
life-saving hemodialysis concentrate products to kidney dialysis
clinics in the United States. For more information, visit
www.RockwellMed.com.
Rockwell Medical Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, and
similar expressions, or statements regarding intent, belief, or
current expectations, are forward looking statements. While
Rockwell Medical believes these forward-looking statements are
reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties (including, without
limitation, those set forth in Rockwell Medical’s SEC filings),
many of which are beyond our control and subject to change. Actual
results could be materially different. Risks and uncertainties
include, but are not limited to: the impact of the COVID-19
pandemic on Rockwell’s business, including any clinical trials, and
the FDA’s response time, the risks of current treatment patterns in
the home infusion setting for iron deficiency anemia and whether
the FDA will raise any issues with the IND during its review
period; and those risks more fully discussed in the “Risk Factors”
section of our Quarterly Report on Form 10-Q for the period ended
June 30, 2021 and of our Annual Report on Form 10-K for the year
ended December 31, 2020, as such description may be amended or
updated in any future reports we file with the SEC. Rockwell
Medical expressly disclaims any obligation to update our
forward-looking statements, except as may be required by law.
ROCKWELL MEDICAL CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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