Rockwell Medical, Inc. Files Pre-IND Meeting Request with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron ...
June 28 2021 - 7:00AM
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 a pre-IND
(Investigational New Drug) meeting request 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. For example, it is
estimated that 40%-55% of all home parenteral nutrition patients
are iron deficient. 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, such as, poor immune function and heart failure.
“This is an important step for Rockwell Medical and home
infusion patients as we believe that FPC is uniquely suited to
address this important unmet clinical need,” said Russell Ellison,
M.D., President and Chief Executive Officer of Rockwell Medical.
“We expect to finalize our Phase 2 clinical study design and
protocol with the advice and guidance of the FDA.”
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. The Company is
developing FPC for the treatment of iron deficiency in patients
outside of dialysis, who are receiving intravenous medications in
the home infusion setting, a large and rapidly growing segment of
healthcare, and where these patients suffer from chronic diseases
associated with high incidence of iron deficiency and anemia. 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, expectations and
beliefs and are subject to various risks and uncertainties
(including, without limitation, those set forth in Rockwell
Medical’s SEC filings), that could cause actual results to differ
materially from those described in the forward-looking statements.
Actual results could be materially different. Risks and
uncertainties include, but are not limited to statements regarding
the therapeutic benefits, plans and objectives for regulatory
approval of the Company’s product(s); ability to obtain FDA
approval and advance our product to market; risks associated with
our development work, including delays, or changes to the timing,
cost and success of our product development activities and clinical
trials; risks of delay in the FDA approval of FPC; risks inherent
in the marketing, sales and commercializing a new product; risks
relating to the size and growth of the home infusion market and
acceptance of FPC; risks of sufficient capital and cash resources,
including access either debt or equity financing to fund such
product development; and the risk of compliance with all FDA and
other government requirements relating to the development and
manufacturing of our product; the impact of the COVID-19 pandemic
(including, applicable international or domestic orders) on our
ability to operate Rockwell’s manufacturing facilities in a manner
that avoids any disruptions, expected financial performance,
including cash flows, revenues, growth, margins, funding, liquidity
and capital resources, and those risks more fully discussed in the
“Risk Factors” section of our Quarterly Report on Form 10-Q for the
period ended March 31, 2021 and of our Annual Report on Form 10-K
for the year ended December 31, 2020, as such descriptions 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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