Rockwell Medical, Inc. Expands Medical Capabilities
– Company adds experienced medical executive to management team and leading nephrologists to
– Objective to become a leading medical organization in the field of dialysis –
Through the ongoing development and commercialization of Dialysate Triferic, and in preparation for the potential approval of I.V. Triferic in 2020, the Company has identified the following key medical priorities to establish and position Triferic as the standard of care in anemia over the next three to five years:
- Development of relationships with Centers of Excellence to assist the Company with real- world data collection, education of the dialysis community, and guidance for various aspects of anemia management and the use of Triferic;
- Collection and analysis of additional retrospective and prospective data to support the real-world impact of Triferic on clinical and health-economic outcomes;
- Enhancement of, and investment in, the Company’s medical affairs capabilities, including engagement with Key Opinion Leaders (KOLs), increased interaction with patient and physician advocacy groups, data publications and abstracts to drive expanded awareness of Triferic;
- Expansion of the Company’s medical education capabilities to challenge an entrenched standard of care and educate clinicians about the unique scientific attributes and benefits of Triferic; and
- Addition of global clinical development expertise to: (1) guide the development of Triferic in key geographies in collaboration with current and future partners; and (2) further explore the clinical and pharmacoeconomic attributes of Triferic to address anemia in ESRD and other medical indications.
With the establishment of these priorities,
Steven Fishbane, MD, Chief of Nephrology of Northwell Healthand Professor of Medicine at the Zucker School of Medicine. Dr. Fishbane is a nephrologist with over 25 years of clinical experience and over 24 years as a medical researcher with more than 210 peer-reviewed publications. He has received multiple honors and holds several appointments, including to the National Quality Forum’s Standing Committee of Admissionsand Readmissions. Through his clinical research, Dr. Fishbane has become renowned for advancement and innovation in the treatment of chronic kidney disease patients. Jay Wish, MD, Professor of Clinical Medicine at Indiana University School of Medicinein Indianapolisand Chief Medical Officer for Dialysis at Indiana University Health. Dr. Wish has a distinguished career in the field of nephrology and dialysis, which includes serving on the Board of Directors of Renal Physicians Associationand the American Association of Kidney Patients(AAKP), where he received AAKP’s Visionary Award in 2005. Dr. Wish is Vice Chairman of the Editorial Advisory Board for Nephrology News & Issuesand serves on the editorial boards of the Journal of the American Society of Nephrology and Clinical Journalof the American Society of Nephrology. At the American Society of Nephrology Conferenceon November 8, 2019, Dr. Wish presented on Triferic in a symposium entitled “Advances in Hemodialysis-Associated Anemia Management: The Benefits of Physiologic Iron Replacement Therapy.” Anatole Besarab, MD, a nephrologist who has served as the Chair and Co-Chair of the NKF Workgroup on Vascular Access. Dr. Besarab has also served on various committees for the FORUM of ESRD networks, the ASN, NKF, ASAIO, and the NIH. He is the author of more than 215 peer reviewed papers, 28 chapters, and 17 monographs. His work has focused primarily on optimizing the management of anemia, particularly on the proper balance between erythropoiesis and iron delivery. He has also served as lead investigator on clinical trials involving HIF-PHI inhibitors.
“To achieve our goal of transforming anemia management for dialysis patients, we are making specific investments in our medical expertise, real world and clinical data, as well as medical education programs,” said
“I am delighted to join the
Triferic is the only
Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Unlike traditional IV iron products, 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.
Notice of Issuance of Inducement Grants
Pursuant to his employment agreement, Dr. Hoffman will be awarded stock-based compensation representing the right to acquire shares of common stock (the “Inducement Grants”). The Inducement Grants will consist of options to purchase up to 250,000 shares of common stock, subject to time-based vesting conditions. The Inducement Grants will be issued upon Dr. Hoffman’s commencement of employment (the “Grant Date”), and all stock options included within the Inducement Grants will have an exercise price equal to the fair value of the common stock on the Grant Date. The Inducement Grants have been approved by the Company’s Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company’s shareholder-approved equity incentive plans as an inducement grant, in accordance with Nasdaq Listing Rule 5635(c)(4).
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'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 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; the pricing and reimbursement status for I.V. Triferic under CMS’ final rule relating to TDAPA as announced by CMS on October 31, 2019; 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.