WIXOM, Mich., March 31, 2020 (GLOBE NEWSWIRE) — Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, announced today the appointment of pharmaceutical industry leader Robert (“Bob”) S. Radie to its Board of Directors, effective March 31, 2020.
“We are pleased to welcome Bob to the Rockwell Medical Board of Directors. Having led numerous companies from their development stage through commercialization, Bob brings deep expertise from the pharmaceutical and biotech industries, with significant executive, commercial, business development and clinical development experience. Bob will be a great asset to Rockwell Medical as we ensure that our novel therapeutic, Triferic® (ferric pyrophosphate citrate), is widely available to hemodialysis patients around the world who can benefit, and further develop our platform for anemia patients with other diseases,”
stated John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical.
“I am delighted to join Rockwell Medical’s Board at this exciting time and to help the Company realize the full potential of its iron maintenance therapy, Triferic. I look forward to working with management and current Board members to achieve Rockwell Medical’s goal of transforming the way anemia is managed in a variety of disease states,”
said Mr. Radie.
Mr. Radie brings more than three decades of industry experience, working in both public and private pharmaceutical and biotech companies across a range of therapeutic areas. He has held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Topaz Pharmaceuticals, Inc., which was sold to Sanofi Pasteur, and Transmolecular, Inc. Mr. Radie also served as Chief Business Officer at Prestwick Pharmaceuticals, Inc., which was sold to Biovail Pharmaceutics; Morphotek, Inc., which was sold to Eisai Co., Ltd.; and Senior Vice President of Strategy and Planning at Vicuron Pharmaceuticals, Inc., which was sold to Pfizer for $1.9 billion in 2005. Mr. Radie began his career at Eli Lilly and Company where he worked for 18 years in sales and marketing positions with increasing levels of responsibility.
Mr. Radie currently holds several Board positions, including Paratek Pharmaceuticals, a public biopharmaceutical company; LPSA, the Pennsylvania industry advocacy group; and Horse Power for Life, a non-profit organization dedicated to improving the quality of life for individuals diagnosed with cancer. He previously served on the Boards of Veloxis Pharmaceuticals, which was recently acquired by Asahi Kasei Corp. for $1.3 billion, and Affinium Pharmaceuticals, a private specialty pharmaceutical company.
Mr. Radie received his B.S. in Chemistry from Boston College.
About Rockwell Medical
Rockwell Medical, Inc. (NASDAQ:RMTI) is a biopharmaceutical company dedicated to transforming 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 renal disease (ESRD). Rockwell Medical’s exclusive renal drug therapy, Triferic (ferric pyrophosphate citrate), is the only FDA-approved therapeutic 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
Triferic is the only FDA-approved therapy in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment. Triferic has a unique and differentiated mechanism of action which has the potential to benefit patients and health care economics. Triferic represents a potential innovative medical advancement in hemodialysis patient iron management– with the potential to become the future standard of care. The Company has two FDA-approved formulations of Triferic (1) Triferic Dialysate and (2) Triferic AVNU.
Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Triferic donates iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood and 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 ESRD 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, Rockwell Medical’s expectations regarding the consummation of the offering, the terms of the offering, and the satisfaction of customary closing conditions with respect to the offering and the anticipated use of the net proceeds of the offering. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “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), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: statements about the issuance of a unique J code for our Triferic powder packet; timing and regulatory approval process for Triferic Dialysate in China; the potential market and commercialization opportunity of Triferic Dialysate in China upon regulatory approval; the timing, as well as commercialization opportunity and process for Triferic AVNU; the potential domestic and international market opportunity for Triferic AVNU, as well as other Rockwell Medical products; CMS’ announced final rule relating to the eligibility criteria for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical’s existing working capital; the success of our commercialization of Triferic Dialysate, which commenced in May 2019; and the timing and success of our efforts to maintain, grow and improve the profit margin of the Company’s concentrate business; and the impact of general economic, industrial or political conditions, as well as recent health conditions in the United States or internationally, as well as those risks more fully discussed in Rockwell Medical’s SEC filings. Accordingly, you should not place undue reliance on these forward-looking statements. Rockwell Medical expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Triferic® is a registered trademark of Rockwell Medical, Inc.
