Rockwell Medical, Inc. has signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co. Ltd., a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. for the rights to commercialize Rockwell’s Triferic and Calcitriol for end-stage-renal-disease 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.

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.

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.

Details of the deal

Rockwell will receive from Wanbang an upfront fee plus regulatory and revenue milestone payments totaling U.S. $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.

“China has been a top priority in our global Triferic licensing strategy,” said Robert L. Chioini, Founder, Chairman and CEO of Rockwell. “This commercialization arrangement enables Rockwell to enter into and capitalize on what is projected to become the largest dialysis market in the world.