Rockwell Medical's Partner Drogsan Pharmaceuticals Submits Marketing Authorization Application in Turkey for Triferic AVNU
April 27 2023 - 6:00AM
Business Wire
Turkish Medicines and Medical Devices Agency
assigns priority review status for Drogsan's Marketing
Authorization application and high priority status for Drogsan's
GMP application for Triferic AVNU
Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a
healthcare company that develops, manufactures, commercializes, and
distributes a portfolio of hemodialysis products to dialysis
providers worldwide, today announced that its international
partner, Drogsan Pharmaceuticals, submitted a Marketing
Authorization application and GMP application for Triferic® AVNU to
the Turkish Medicines and Medical Devices Agency ("TMMDA"), for
which Drogsan received priority status and high priority status,
respectively.
Triferic AVNU (ferric pyrophosphate citrate injection) is an
iron replacement product indicated to maintain hemoglobin in adult
patients undergoing hemodialysis. In June 2021, Rockwell entered
into license and supply agreements with Drogsan, one of the leading
pharmaceutical companies in Turkey, for the rights to commercialize
Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms
of the agreements, Drogsan will be the exclusive commercialization
partner for Triferic (dialysate) and Triferic AVNU in Turkey. In
consideration for the license, Rockwell received an upfront payment
and will be eligible for milestone payment and royalties on net
sales. Drogsan will be responsible for all regulatory approval and
commercialization activities, and the Company will supply the
product to Drogsan for Turkey.
"Rockwell’s international partnerships have the potential to
generate near- and long-term revenue for Rockwell. We continue to
work diligently with our international partners to bring Triferic
to market in their respective territories. We are excited that
Drogsan is making great strides in its plan to register and
commercialize Triferic AVNU in Turkey," said Mark Strobeck, Ph.D.,
Rockwell Medical’s President and CEO. "Taking into consideration
that Drogsan was granted an accelerated review for Triferic AVNU
with the Turkish regulatory authority, we anticipate approval for
Triferic AVNU in 2024."
About Rockwell Medical
Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company
that develops, manufactures, commercializes, and distributes a
portfolio of hemodialysis products for dialysis providers
worldwide. Rockwell Medical's mission is to provide dialysis
clinics and the patients they serve with the highest quality
products supported by the best customer service in the industry.
Rockwell is focused on innovative, long-term growth strategies that
enhance its products, its processes, and its people, enabling the
Company to deliver exceptional value to the healthcare system and
provide a positive impact on the lives of hemodialysis patients.
Hemodialysis is the most common form of end-stage kidney disease
treatment and is usually performed at freestanding outpatient
dialysis centers, at hospital-based outpatient centers, at skilled
nursing facilities, or in a patient’s home. Rockwell Medical's
products are vital to vulnerable patients with end-stage kidney
disease, and the Company is relentless in providing unmatched
reliability and customer service. Rockwell Medical is the second
largest supplier of acid and bicarbonate concentrates for dialysis
patients in the United States and has the vision of becoming the
leading global supplier of hemodialysis concentrates. Certified as
a Great Place to Work® in 2023, Rockwell Medical is Driven to
Deliver Life-Sustaining Dialysis SolutionsTM. For more information,
visit www.RockwellMed.com.
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," "look forward to," "remain
confident," “are determined,” “are on track,” “are resolute in our
vision,” "work to," "drive towards," or the negative of these
terms, and similar expressions, or statements regarding intent,
belief, or current expectations, are forward looking statements.
There can be no assurance that Rockwell’s international
partnerships will generate near- and long-term revenue for
Rockwell; that Triferic will be brought to market in territories
where Rockwell has partnerships; or that Triferic AVNU will be
approved in Turkey in 2024 or at all. 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 those risks more fully discussed in the "Risk Factors"
section of our Annual Report on Form 10-K for the year ended
December 31, 2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230427005345/en/
Heather R. Hunter SVP, Chief Corporate Affairs Officer (248)
432-1362 IR@RockwellMed.com
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