RMTI stock moved higher on January 15, 2020, after the company announced an exclusive supply agreement.

Rockwell Medical, a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, today announced that it has entered into license and supply agreements with a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. (together, “Sun Pharma”), for the rights to commercialize Triferic (ferric pyrophosphate citrate) in India.

Under the terms of the agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic in India and Rockwell Medical will supply the product to Sun Pharma. In consideration for the license, Rockwell Medical will receive an upfront fee, and will be eligible for milestone payments and royalties on net sales.

Sun Pharma is the largest pharmaceutical company in India, with more than $4 billion in annual sales globally. Sun Pharma will leverage its market leading nephrology franchise to promote Triferic to nephrologists in India. A Joint Alliance Committee, comprised of members from Rockwell Medical and Sun Pharma, will guide the development and execution for Triferic in India. Sun Pharma will be responsible for all clinical, regulatory and commercialization activities.

“We are pleased to establish this important relationship with Sun Pharma, which has a strong presence in the nephrology segment in India. With a dedicated business unit, market leading sales force and medical support personnel, together with its experience with license and distribution partnerships with large global pharmaceutical companies, Sun Pharma is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic. This is a meaningful advancement for Triferic as we expand our global footprint and drive the long-term value of Triferic,” said Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

On November 25, 2019, TheFly reported that in an untitled letter posted to the FDA webpage sent to Rockwell Medical, the FDA stated: “The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration has reviewed the Rockwell Medical, Inc’s webpage titled, “Triferic” (webpage) under the “Therapeutic Focus” tab for TRIFERIC solution and powder packet for addition to bicarbonate concentration. The webpage is false or misleading in that it presents information about the benefits of Triferic but fails to include any risk information about the drug, makes false or misleading claims and/or representations about the risks and efficacy associated with Triferic, and omits other material facts. Thus, the webpage misbrands Triferic within the meaning of the Federal Food, Drug, and Cosmetic Act and makes its distribution violative.” Source: https://www.fda.gov/media/133021/download

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