– CFDA’s Acceptance of Triferic Submission Initiates Process
for Drug Approval in Chinese Dialysis Market –
WIXOM, Mich., March 21, 2016 (GLOBE NEWSWIRE) — 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 that its Triferic drug product submission to the China Food and Drug Administration (CFDA) has been accepted. Drug registration must be submitted to and accepted by the CFDA for a product to achieve regulatory approval for commercialization in China.
Robert L. Chioini, Founder, Chairman and CEO of Rockwell stated, “We are pleased that the CFDA has accepted our drug filing and has begun the review process for regulatory approval of Triferic as an iron maintenance therapy in patients with chronic kidney disease on hemodialysis. The drug approval process in China requires we file a Clinical Trial Application, which is based on the same information that was included in our U.S. FDA approved NDA. We plan to work with our Chinese partner, Wanbang Biopharma, to provide any additional clinical information required to complete the registration process for Triferic commercialization in China. We expect that the Chinese dialysis market will become the largest in the world over the next few years and that Triferic, once CFDA approved, should generate substantial revenue for Rockwell.”
On February 16, 2016, Rockwell signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co., Ltd. (Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA:600196 and HKG:02196), for the rights to commercialize Triferic and Calcitriol for End-Stage-Renal-Disease (ESRD) patients. Triferic is Rockwell’s proprietary iron replacement and hemoglobin maintenance drug for treating anemia. Calcitriol is Rockwell’s generic (active vitamin D) injection for treatment of secondary hyperparathyroidism in dialysis patients.
Under the terms of the agreement, Wanbang will become the exclusive distributor for Triferic and Calcitriol in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. In consideration for the exclusive rights, Rockwell will receive from Wanbang regulatory and revenue milestone payments totaling USD$39 million in aggregate, of which $4 million has been received. The agreement is structured for Rockwell to receive its primary revenue from ongoing earnings from product sales of Triferic and Calcitriol in China, and other additional Triferic therapeutic indications. Rockwell retains manufacturing responsibility of all products. Wanbang is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In addition to the hemodialysis indication, Wanbang has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang is responsible for all clinical, regulatory and marketing expenses for Triferic and Calcitriol in China as well as development and regulatory costs for new Triferic indications.
Wanbang Biopharmaceuticals is a leading pharmaceutical company in China that specializes in research, production and marketing of medicines for endocrinology, cardiovascular disease and renal diseases. Wanbang is a subsidiary of Fosun Pharma which is listed on the Shanghai Stock Exchange (SHA:600196) and the Stock Exchange of Hong Kong Limited (HKG:02196). Fosun Pharma, one of the major shareholders of Sino Pharma (HKG:1099) who is the largest drug distributor in China, is part of the Fosun Group, the leading non-state owned enterprise group in China which is listed on the Hong Kong stock exchange (HKG:0656). In addition to its comprehensive therapeutic product portfolio, Wanbang and Fosun Pharma have sound relationships with public healthcare institutions and providers and directly own and operate a network of private hospitals in China.
Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. Triferic delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Please visit www.triferic.com.
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 Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin).
Rockwell’s FDA approved generic drug Calcitriol is for treating 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 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 U.S. manufacturing/distribution facilities.
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.
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.
Michael Rice, Investor Relations; 646-597-6979
Triferic® is a registered trademark of Rockwell Medical, Inc.