Rockwell Medical Submits Calcitriol Manufacturing Data to FDA for Approval

Rockwell Medical Submits Calcitriol Manufacturing Data to FDA for Approval 
Company Intends to Sell Calcitriol Vitamin D Injection Into Dialysis
Market 
WIXOM, MI -- (Marketwire) -- 04/01/13 --  Rockwell Medical, Inc.
(NASDAQ: RMTI), a fully-integrated biopharmaceutical company
targeting end-stage renal disease (ESRD) and chronic kidney disease
(CKD) with innovative products and services for the treatment of iron
deficiency, secondary hyperparathyroidism and hemodialysis, announced
today they have submitted data to the FDA for approval to manufacture
Calcitriol, the Company's injectable active vitamin D drug.  
Mr. Robert L. Chioini, Founder, Chairman and CEO, stated, "Achieving
this significant milestone is very important to our strategic
initiative to begin selling drugs in the renal market. Coupled with
the considerable clinical progress we continue to make with our
iron-delivery drug SFP, we believe Rockwell is uniquely positioned
for dynamic sales growth in the hemodialysis market. We expect
Calcitriol alone to generate significant additional sales and profit
once launched commercially." 
About Calcitriol
 Calcitriol injection is indicated in the management
of hypocalcemia in patients undergoing chronic renal dialysis. It has
been shown to significantly reduce elevated parathyroid hormone
levels. Reduction of PTH has been shown to result in an improvement
in renal osteodystrophy. Calcitriol is the most active known form of
vitamin D3 in stimulating intestinal calcium transport. Calcitriol
when administered by bolus injection is rapidly available in the
blood stream.  
About Rockwell Medical
 Rockwell Medical is a fully-integrated
biopharmaceutical company targeting end-stage renal disease (ESRD)
and chronic kidney disease (CKD) with innovative products and
services for the treatment of iron deficiency, secondary
hyperparathyroidism and hemodialysis.  
Rockwell's lead drug candidate in late-stage clinical development is
for the treatment of iron deficiency and is called Soluble Ferric
Pyrophosphate (SFP). SFP delivers iron to the bone marrow of dialysis
patients in a non-invasive, physiologic manner via dialysate during
their regular dialysis treatment. In order to prevent or treat
anemia, sufficient availability of iron and erythropoietin mu
st be
present in the bone marrow to generate healthy red blood cells. In
completed clinical trials to date, SFP has demonstrated that it can
safely deliver sufficient iron to the bone marrow. SFP is currently
in ongoing Phase 3 clinical studies (CRUISE-1 and CRUISE-2) and
expected to address an estimated $600M U.S. and $1B global market.  
Rockwell is preparing to launch its FDA approved generic drug called
Calcitriol. Calcitriol active vitamin D injection is indicated in the
management of hypocalcemia in patients undergoing chronic renal
dialysis. It has been shown to significantly reduce elevated
parathyroid hormone levels. Reduction of PTH has been shown to result
in an improvement in renal osteodystrophy. Rockwell intends to launch
Calcitriol as soon as it receives FDA manufacturing approval,
expected in 2013, addressing an estimated $350M U.S. market.  
Rockwell is also an established manufacturer and leader in delivering
high-quality hemodialysis concentrates/dialysates to dialysis
providers and distributors in the U.S. and abroad. These products are
used to maintain human life, by removing toxins and replacing
critical nutrients in the dialysis patient's bloodstream. Rockwell's
has three manufacturing and distribution facilities in the United
States and its operating infrastructure is a ready-made sales and
distribution channel that is able to provide seamless integration
into the commercial market for its drug products, Calcitriol and SFP
upon FDA market approval.  
Rockwell's exclusive renal drug therapies support disease management
initiatives to improve the quality of life and care of dialysis
patients and are intended to deliver safe and effective therapy,
while decreasing drug administration costs and improving patient
convenience. Rockwell Medical is developing a pipeline of drug
therapies, including extensions of SFP for indications outside of
hemodialysis. Please visit www.rockwellmed.com for more information.
For a demonstration of SFP's unique mechanism of action in delivering
iron via dialysate, please view the animation video at
http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html. 
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the federal securities laws,
including, but not limited to, Rockwell's intention to launch
Calcitriol and SFP following FDA approval. Words such as "may,"
"might," "will," "should," "believe," "expect," "anticipate,"
"estimate," "continue," "predict," "forecast," "project," "plan,"
"intend" or 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. Thus, actual results
could be materially different. Rockwell Medical expressly disclaims
any obligation to update or alter statements whether as a result of
new information, future events or otherwise, except as required by
law. 
Contact: 
Michael Rice
Investor Relations
(646) 597-6979 
David Connolly
Media Contact
(617) 374-8800 
 
 
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