×

Rockwell Medical Enters Into Exclusive License Agreement With Wanbang Biopharmaceutical Co., Ltd. to Commercialize Triferic® in China

WIXOM, Mich., Feb. 16, 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 it has 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 Rockwell’s Triferic and Calcitriol for End-Stage-Renal-Disease (ESRD) patients, that also includes new therapeutic indications for Triferic, in the People’s Republic of China. 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 an upfront fee plus regulatory and revenue milestone payments totaling USD$39 million in aggregate. Notably, Rockwell will receive ongoing earnings from product sales of Triferic and Calcitriol, 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.

“We are thrilled to establish this strategic partnership with Wanbang,” stated Robert L. Chioini, Founder, Chairman and CEO of Rockwell. “China has been a top priority in our global Triferic licensing strategy, and this agreement further validates Triferic’s potential for becoming the world-wide standard of care in iron maintenance therapy for the treatment of anemia. This commercialization arrangement enables Rockwell to enter into and capitalize on what is projected to become the largest dialysis market in the world. There are about 300,000 dialysis patients currently receiving hemodialysis in China and that market is expected to double over the next few years as the Chinese government, in conjunction with the private sector, establishes the infrastructure to serve the nearly 2 million patients who are presently in need of hemodialysis but lack access. We are very pleased with this commercialization arrangement in which our primary economic value will be derived from product sales in this fast-growing Chinese market.” Mr. Chioini further stated, “We are excited to work with Wanbang, a leading company in the Chinese healthcare market and one of the key suppliers of biosimilar ESA product and other drugs in the renal space. Wanbang, and their experienced team, is highly skilled and intensely focused on leveraging their business into the forefront of the rapidly growing domestic dialysis market in China, and we expect them to have great success selling Triferic and Calcitriol.”

Mr. Yifang Wu, Chief Operating Officer of Fosum Pharma, Chairman and CEO of Wanbang, added, “We are very excited to have partnered with Rockwell Medical and to be able to have the opportunity to offer such great drugs to the Chinese hemodialysis market. We believe Triferic is a revolutionary iron replacement product that will greatly improve the lives of Chinese dialysis patients and we intend to work in partnership with Rockwell management to offer it to patients as fast as possible. The opportunity to market Triferic in other therapeutic indications is exciting as well. Wanbang is committed to addressing the needs of patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital settings. This partnership enhances Wanbang’s product portfolio with the addition of Rockwell’s high-quality drug products.”

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.

About Triferic
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.

Triferic® is a registered trademark of Rockwell Medical, Inc.

Michael Rice, Investor Relations; 646-597-6979

Source:Rockwell Medical, Inc.