Rockwell Medical Announces Dosing of First Patient in Pivotal Triferic Phase 3 Trial by Partner, Wanbang Biopharmaceuticals, in China - Seite 2

Rockwell Medical signed exclusive licensing and manufacturing supply agreements in 2016 with Wanbang Biopharmaceuticals for the rights to commercialize Triferic in China. Under the terms of the agreement, Wanbang Biopharmaceuticals became the exclusive distributor for Triferic 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. Wanbang Biopharmaceuticals is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In consideration for the exclusive rights, Rockwell received an upfront fee and is entitled to a regulatory approval milestone, revenue milestone payments, and Rockwell is entitled to receive ongoing earnings from product sales of Triferic and other additional Triferic therapeutic indications that Wanbang Biopharmaceuticals may develop. In addition to the hemodialysis indication, Wanbang Biopharmaceuticals has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang Biopharmaceuticals is responsible for all clinical, regulatory and marketing expenses for Triferic in China as well as development and regulatory costs for new Triferic indications. Rockwell retains manufacturing responsibility of all products.

About Rockwell Medical

Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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 kidney disease. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for maintenance of hemoglobin in hemodialysis patients. 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.

About Triferic Dialysate and Triferic AVNU

Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.