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Sun Pharma and Rockwell Medical enter into licensing agreement for Triferic in India

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Sun Pharma and Rockwell Medical enter into licensing agreement for Triferic in India

Sun Pharma and Rockwell Medical enter into licensing agreement for Triferic in India

[caption id="attachment_9277" align="aligncenter" width="747"]Press Release Press Release[/caption] Mumbai, India, January 15, 2020 - 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 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 End Stage Renal Disease patients. Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara ? 390 012. India References 1. http://www.healthdata.org/india 2. https://cjasn.asnjournals.org/content/13/5/802 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. Please visit www.rockwellmed.com for more information. 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. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. Contacts: Investors: Media: Nimish Desai Gaurav Chugh Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 4324, Xtn 5373 Tel Direct +91 22 4324 2778 Tel Direct +91 22 4324 5373 Mobile +91-98203 30182 Mobile +91 98104 71414 E mail nimish.desai@sunpharma.com E mail gaurav.chugh@sunpharma.com

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