WIXOM, Mich., Jan. 09, 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 Russell H. Ellison, MD, MSc, to its Board of Directors, effective January 9, 2020.
Dr. Ellison has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades. His broad experience includes board of director, chief executive and medical executive roles, with expertise in medical strategy, clinical development, global medical affairs, regulatory affairs and public health policy in major markets and developing countries. Dr. Ellison has a deep understanding of the renal space based on experiences with companies developing therapeutic products that address kidney disease and renal anemia, including Hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitors.
“Russell’s broad industry experience with public biotechnology companies and especially his extensive knowledge of the renal and anemia space makes him an ideal addition to our Board. His leadership will serve us well as we commercialize and develop Triferic® (ferric pyrophosphate citrate) for hemodialysis patients around the world, implement our plans for building a leading medical organization, and further the clinical development of our therapeutic platform as we seek to transform the way anemia is managed in a variety of disease states,” stated John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical.
“It is an honor to join Rockwell Medical’s Board and to have the opportunity to contribute to the advancement of such an innovative therapeutic. There is a global opportunity for Triferic® (ferric pyrophosphate citrate), and I am eager to work alongside the current Board members and management team to guide the path forward and ensure that patients have access to this unique iron maintenance therapy,” said Russell H. Ellison, MD, MSc.
Dr. Ellison’s broad experience and leadership positions include Chief Executive Officer of the privately held biotechnology company, Promedior, Inc., which focused on, among other indications, kidney fibrosis, and successfully completed the company’s strategic sale in December 2018; President and CEO of Bond Biosciences, Inc., a biotech start up developing a drug addressing the toxic impact of iron overload in the body; Executive Director of Torreya Advisors, LLC a global investment banking boutique serving companies in the life sciences industry; Chairman and CEO of Assembly Biosciences, Inc. (formerly, Ventrus Biosciences, Inc.); Executive Vice President of Paramount Biosciences LLC, Vice President of Clinical Development at FibroGen, Inc. where he played a key role in the completion of a phase 2 trial with a HIF-PH inhibitor in anemia for Chronic Kidney Disease (CKD) patients; Vice President of Medical Affairs and Chief Medical Officer of Sanofi-Synthelabo, Inc.; and Vice President, Medical Affairs and Chief Medical Officer of Hoffman La Roche, Inc. Additionally, Dr. Ellison has previously served as an Independent Board Director for several private and public companies including, among others, Cougar Biotechnology Inc., ProSanos Corporation, Cormedix Inc., a cardio-renal clinical stage company, and Mt. Cook, a urology-focused company.
Dr. Ellison received an MSc from The London School of Tropical Medicine and Hygiene, and an MD from the University of British Columbia.
About Rockwell Medical
Rockwell Medical 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, is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. The Company has developed multiple formulations of Triferic (1) FDA-approved Dialysate Triferic, and (2) I.V. Triferic, for which the Company filed a New Drug Application in May 2019. 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. Please visit www.rockwellmed.com for more information.
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 provide significant benefits to 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.
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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.
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%).
For more information, including full prescribing information, visit: http://www.triferic.com.
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 intention to bring to market Triferic, and I.V. Triferic. 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'sSEC 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; CMS’ announced final rule relating to eligibility criteria for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical’s existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company’s concentrate business. 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.
Lisa M. Wilson, In-Site Communications, Inc.
Source: Rockwell Medical, Inc.
Source: Rockwell Medical, Inc.