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Rockwell Medical's Partner Drogsan Pharmaceuticals Submits Marketing Authorization Application in Turkey for Triferic AVNU
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Rhea-AI Sentiment
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Rhea-AI Summary
Rockwell Medical has announced that its international partner, Drogsan Pharmaceuticals, received priority review status for the Marketing Authorization application and high priority status for the GMP application of Triferic AVNU from the Turkish Medicines and Medical Devices Agency. Triferic AVNU is an iron replacement therapy aimed at maintaining hemoglobin levels in adult hemodialysis patients. Rockwell entered license and supply agreements with Drogsan in June 2021, allowing Drogsan to exclusively commercialize Triferic products in Turkey. With steady progress towards regulatory approval anticipated in 2024, Rockwell Medical is optimistic about generating revenue through these international partnerships, enhancing its growth strategy in the hemodialysis market.
Positive
Drogsan received priority review for Triferic AVNU, potentially accelerating market entry.
Partnership with Drogsan expected to generate near- and long-term revenue for Rockwell Medical.
Regulatory approval for Triferic AVNU in Turkey anticipated in 2024.
Negative
None.
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
WIXOM, Mich.--(BUSINESS WIRE)--
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'sSEC 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.
Triferic AVNU is an iron replacement product indicated to maintain hemoglobin in adult patients undergoing hemodialysis.
Who is responsible for the regulatory approval of Triferic AVNU in Turkey?
Drogsan Pharmaceuticals is responsible for all regulatory approval and commercialization activities for Triferic AVNU in Turkey.
When was the Marketing Authorization application for Triferic AVNU submitted?
The Marketing Authorization application for Triferic AVNU was submitted recently but the specific date is not provided in the PR.
What does priority review status mean for Triferic AVNU?
Priority review status indicates that the Turkish Medicines and Medical Devices Agency will expedite the review process for Triferic AVNU's marketing application.
