Mumbai - Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, 'Sun Pharma' and includes its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries has entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialize Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India.
Triferic is approved in USA.
As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialization partner for Triferic during the term of the agreement, subject to its approval in India. In consideration for the license, Rockwell will be eligible for upfront and milestone payments as well as royalty on net sales. The financial terms of the agreement are confidential.
Kirti Ganorkar, CEO of India business, Sun Pharma, said, 'We are excited to build a partnership with Rockwell who has developed an innovative product, Triferic for haemodialysis patients. Triferic is an innovative anaemia therapy for the patients who are undergoing haemodialysis and offers a unique treatment option. Triferic will help Sun Pharma expand its portfolio in its core therapy areas.'
According to the 2017 Global Burden of Disease Study, chronic kidney disease was the 10th leading cause of mortality in India, having risen from 14th rank in 20071. In India, there are approximately 130,000 patients receiving hemodialysis, and the number is increasing by about 232 per million population2.
About Triferic
Triferic is the only USFDA-approved therapy in the U.S. indicated to replace iron and maintain haemoglobin in hemodialysis patients via dialysate during each dialysis treatment. Triferic has a unique and differentiated mechanism of action which has the potential to benefit patients and health care economics. Triferic represents a potential innovative medical advancement in hemodialysis patient iron management- with the potential to become the future standard of care.
Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains haemoglobin 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 haemoglobin, 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 End Stage Renal Disease patients.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company dedicated to transforming 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 renal disease (ESRD). Rockwell Medical's exclusive renal drug therapy, Triferic (ferric pyrophosphate citrate), is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. The Company has developed multiple formulations of Triferic (1) FDA-approved Dialysate Triferic, and (2) I.V. Triferic, for which the Company filed a New Drug Application in May 2019. 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 Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver highquality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D.
Contact:
Nimish Desai
Tel: +91 22 4324 4324
Email: nimish.desai@sunpharma.com
SUN PHARMACEUTICAL INDUSTRIES LTD. 
