Rockwell Medical Announces Regulatory Approval of Triferic® AVNU in South Korea

Rhea-AI Summary

Rockwell Medical has received regulatory approval from the Ministry of Food and Drug Safety in South Korea for its iron therapy product, Triferic, targeting the 82,000+ hemodialysis patients annually. An exclusive commercialization agreement with Jeil Pharmaceutical allows for the launch of Triferic and Triferic AVNU in mid-2022. This marks a significant step in expanding Rockwell's global reach, with potential milestone payments and royalties boosting its financial prospects. Both Triferic formulations are designed to maintain hemoglobin levels without increasing iron stores, addressing a critical need in end-stage kidney disease treatment.

Positive

• Regulatory approval obtained for Triferic in South Korea.
• Exclusive commercialization agreement with Jeil Pharmaceutical enhances market access.
• Potential for milestone payments and royalties from Triferic sales.

Negative

• None.

-Commercial launch expected in June/July 2022-

-Rockwell Medical has an exclusive license agreement with Jeil Pharmaceutical Co., Ltd., for the rights to Triferic^® and Triferic^® AVNU in South Korea-

-More than 82,000 patients receiving hemodialysis annually in So. Korea-

WIXOM, Mich., Jan. 13, 2022 (GLOBE NEWSWIRE) -- 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 its partner in South Korea, Jeil Pharmaceutical Co., Ltd. (“Jeil”), has received regulatory approval by the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic Injection (ferric pyrophosphate citrate sodium sulfate co-precipitate hydrate injection) marketed in the United States as Triferic AVNU (ferric pyrophosphate citrate injection) for iron supplementation therapy and maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

Rockwell Medical has an exclusive license agreement with Jeil for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil is the exclusive development and commercialization partner for Triferic in South Korea. Rockwell Medical will supply the product to Jeil. In consideration for the license, Rockwell Medical has received an upfront fee and will be eligible for milestone payments and royalties on net sales. Product sales are anticipated to begin in June/July of 2022.

“The approval by MFDS is an important milestone for Rockwell Medical, but more importantly, for the more than 82,000 patients in South Korea undergoing hemodialysis,” said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. “With its considerable development and commercialization capabilities and local market expertise, we believe Jeil is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic across South Korea. Today’s announcement marks another meaningful advancement for Triferic, as we build our global footprint and increase the long-term value of Triferic.”

About Triferic Dialysate and Triferic AVNU

Triferic Dialysate (ferric pyrophosphate citrate) and Triferic AVNU (ferric pyrophosphate citrate injection) 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 replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating functional iron deficiency in end-stage kidney disease patients.

The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.

IMPORTANT SAFETY INFORMATION FOR TRIFERIC AND TRIFERIC AVNU

INDICATION

TRIFERIC and TRIFERIC AVNU are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Limitations of Use

TRIFERIC AVNU is not intended for use in patients receiving peritoneal dialysis. TRIFERIC AVNU has not been studied in patients receiving home hemodialysis.

Warnings and Precautions

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.

Adverse Reactions
Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

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 those risks more fully discussed in the “Risk Factors” section of our Quarterly Report on Form 10-Q for the period ended September 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 Partners
212.600.1902
Rockwell@argotpartners.com 

Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com 

FAQ

What is the significance of Rockwell Medical's regulatory approval in South Korea for RMTI?

The regulatory approval of Triferic in South Korea allows Rockwell Medical to address the needs of over 82,000 hemodialysis patients, significantly enhancing the company's market reach and potential revenue.

When is the commercial launch of Triferic expected in South Korea?

The commercial launch of Triferic in South Korea is expected in June/July 2022.

What partnership does Rockwell Medical have in South Korea for Triferic?

Rockwell Medical has an exclusive license agreement with Jeil Pharmaceutical Co., Ltd. for the development and commercialization of Triferic in South Korea.

How does Triferic benefit hemodialysis patients?

Triferic is indicated for iron replacement and maintaining hemoglobin levels in hemodialysis patients, providing a critical treatment to manage iron deficiency without increasing iron stores.