World News: 02:30 GMT Wednesday 15th January 2020. [Rockwell Medical, Inc. via Globe Newswire via SPi World News]
WIXOM, Mich., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the “Company”), 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.
Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Triferic donates iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood and is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no reports of anaphylaxis in over 1,000,000 patient administrations, addressing a significant medical need in overcoming Functional Iron Deficiency (FID) in ESRD patients. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.
Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
For more information, including full prescribing information, visit: .
Triferic is a registered trademark of Rockwell Medical, Inc.
Globe Newswire: 02:30 GMT Wednesday 15th January 2020
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