Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), 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 entered into an exclusive license agreement with Jeil
Pharmaceutical Co., Ltd. (“Jeil”), for the rights to commercialize
Triferic (ferric pyrophosphate citrate) in South Korea.
Under the terms of the license agreement, Jeil
will be the exclusive development and commercialization partner for
Triferic in South Korea and Rockwell Medical will supply the
product to Jeil. In consideration for the license, Rockwell Medical
will receive an upfront fee and will be eligible for milestone
payments and royalties on net sales.
Jeil has developed and supplied pharmaceutical
products and contributed to the growth and development of the
pharmaceutical industry in Korea since its founding in 1959. Jeil,
listed on the Korea Composite Stock Price (KOSPI) index since 1988,
has approximately 1,000 employees and more than $576 million in
sales for the year ended 2019. Jeil will leverage its strong
development and commercialization capabilities and local market
expertise to promote Triferic to nephrologists in South Korea. A
Joint Alliance Committee, comprised of members from Rockwell
Medical and Jeil, will guide the development and execution for
Triferic in South Korea. Jeil will be responsible for all
regulatory and commercialization activities. Product sales are
anticipated to begin in early 2022, subject to regulatory
approval.
“We are pleased to announce the license
agreement with Jeil and the establishment of a relationship between
our two companies,” said Russell Ellison, M.D., President and Chief
Executive Officer of Rockwell Medical. “With its substantial
development and commercialization capabilities and local market
expertise, Jeil is well positioned to ensure that hemodialysis
patients have access to our innovative therapeutic across South
Korea. Today’s news marks another meaningful advancement for
Triferic, as we expand our global footprint and drive the long-term
value of Triferic.”
“We welcome this opportunity to collaborate with
Rockwell Medical to provide Triferic to patients on hemodialysis in
South Korea,” said Suk-Je Sung, President and Chief Execute Officer
of Jeil. “There remains a significant unmet need for innovative
medicine to address iron deficiency in these patients, with more
than 78,000 patients receiving hemodialysis every year and we
expect the number of CKD dialysis patients to continue to increase
and double by 2030.”
Torreya Partners acted as a financial advisor to
Rockwell Medical for this transaction.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company
dedicated to transforming iron deficiency and anemia management in
a wide variety of therapeutic areas and across the globe, improving
the lives of very sick patients. The Company’s initial focus is the
treatment of anemia in end-stage kidney disease (ESKD). Rockwell
Medical's exclusive renal drug therapies, Triferic (ferric
pyrophosphate citrate) Dialysate and Triferic AVNU, are the only
FDA-approved therapeutics indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. Rockwell
Medical is also an established manufacturer, supplier and leader in
delivering high-quality hemodialysis concentrates/dialysates to
dialysis providers and distributors in the U.S. and abroad.
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate and Triferic AVNU are the
only FDA-approved therapies in the U.S. indicated to replace iron
and maintain hemoglobin in hemodialysis patients during each
dialysis treatment. Triferic Dialysate and Triferic AVNU have a
unique and differentiated mechanism of action, which has the
potential to benefit patients and health care economics. Triferic
Dialysate and Triferic AVNU represent a potential innovative
medical advancement in hemodialysis patient iron management – with
the potential to become the future standard of care.
Triferic Dialysate and Triferic AVNU both
deliver approximately 5-7 mg iron with every hemodialysis treatment
to the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which is then transported directly to the bone
marrow to be incorporated into hemoglobin, with no increase in
ferritin (stored iron and inflammation) and no reports of
anaphylaxis in over 1,000,000 patient administrations, addressing a
significant medical need in overcoming Functional Iron Deficiency
(FID) in ESKD patients.
Important Safety Information
Serious hypersensitivity reactions, including
anaphylactic-type reactions, some of which have been
life-threatening and fatal, have been reported in patients
receiving parenteral iron products. Patients may present with
shock, clinically significant hypotension, loss of consciousness,
and/or collapse. Monitor patients for signs and symptoms of
hypersensitivity during and after hemodialysis until clinically
stable. Personnel and therapies should be immediately available for
the treatment of serious hypersensitivity reactions.
Hypersensitivity reactions have been reported in 1 (0.3%) of 292
patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis
blood samples. Post dialysis serum iron parameters may overestimate
serum iron and transferrin saturation.
The most common adverse reactions (≥3% and at
least 1% greater than placebo) in controlled clinical studies
include: procedural hypotension (21.6%), muscle spasms (9.6%),
headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%),
dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract
infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous
(AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage
(3.4%).
Forward-Looking Statements
Certain statements in this press release may
constitute “forward-looking statements” within the meaning of the
federal securities laws, including, but not limited to, the receipt
of an upfront fee and milestone payments and royalties by Rockwell
Medical, the timing of product sales in South Korea, the receipt of
regulatory approvals in South Korea and the potential market
opportunity for Triferic in South Korea. 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 (including,
applicable federal, state or local orders) on business and
operating results; receipt of regulatory approval for Triferic in
South Korea; our ability to achieve milestones and receive royalty
payments; anticipated market opportunity in South Korea; 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, 2020
and of our Annual Report on Form 10-K for the year ended December
31, 2019, 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.
Triferic® is a registered trademark of Rockwell
Medical, Inc. Triferic AVNU is pending with the U.S. Patent
and Trademark Office. All other product names, logos,
and brands are property of their respective owners in the
United States and/or other countries. All company,
product and service names used on this website are for
identification purposes only. Use of these names, logos, and brands
does not imply endorsement.
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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