WIXOM, MI - October 24, 2013 - Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the presentation schedule for five individual Triferic™ clinical abstracts selected by ASN's Program Committee for poster and oral presentation at the ASN Kidney Week 2013 Annual Meeting, November 7-10 in Atlanta, GA. Triferic™ is the Company's late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.
The following Triferic™ clinical posters will be presented November 7-10, 2013 at ASN in the main exhibit hall and the authors will be available between 10:00am and 12:00pm EDT, unless otherwise noted:
November 7, 2013 Thursday Posters:
- Triferic™ (SFP) Administered via Dialysate Shows no Acute Safety Signals
- Triferic™ (SFP) Administered via Dialysate Reduces ESA and IV Iron Requirements while Maintaining Hgb in CKD-HD Patients
November 9, 2013 Saturday Posters:
- Structural, Physical and Functional Characterization of Triferic™ (SFP), a Novel Iron Compound for Pharmaceutical Applications
- Continuous, Maintenance Iron Therapy Using Triferic™ (SFP) Infusion via Hemodialysate in CKD-HD; Phase III CRUISE Studies
- Triferic™ (SFP) Administered via Dialysate Reduces ESA Requirements in CKD-HD Patients with ESA Hypo-response; PRIME Study -- Oral Presentation at 5:18pm EDT during the Dialysis Anemia Free Communications
Rockwell will also showcase Triferic™ to the scientific community by participating in the ASN "Innovators Place 2013" during the ASN Kidney Week 2013 Annual Meeting. "Innovators Place" offers the opportunity for scientific discourse between scientific and medical representatives of product innovators and the nephrology community, regarding investigational medical products pending FDA market approval, specific to technologies of interest to the nephrology medical community. "Innovators Place" will be part of the Annual Meeting Scientific Exposition held November 7-9, from 9:30am - 2:30pm each day in Hall B3 of the convention center. Innovators Place will have its own private area and is limited to twenty (20) participants.
Triferic™ is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron that is lost during every dialysis treatment. Triferic™ is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic, which is subsequently mixed into dialysate. Once in the dialysate, Triferic™ crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose.
About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell's lead drug candidate Triferic™ is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic™ delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic™ has completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic™ is expected to address an estimated $600M U.S. market.
Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to launch Calcitriol once it receives FDA manufacturing approval, addressing an estimated $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell has three manufacturing/distribution facilities located in the U.S. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and Triferic™ upon FDA market approval.
Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic™ for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of the Triferic™ unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and Triferic™ following FDA approval. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan", "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. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
SOURCE: Rockwell Medical Technologies, Inc.