Sun Pharma and Bayer sign marketing and distribution agreement for second brand of Finerenone in India

FOR IMMEDIATE RELEASE Bayer and Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India • Already successful in the Indian market, Finerenone was first launched by Bayer in India in August 2022 under the brand name Kerendia™ • Sun Pharma to market the drug under the brand name Lyvelsa® Mumbai & Ahmedabad, India, January 17, 2024: Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) and Bayer today announced that both companies have signed an agreement to market and distribute a second brand of Finerenone in India. Finerenone, a patented medicine is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non -fatal myocardial infarction, and hospitalization for hear t failure in adult patients with chronic kidney disease associated with type 2 diabetes mellitus. Under the terms of the agreement, Bayer has granted the non -exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa®. Finerenone was first launched by Bayer under the brand name Kerendia TM in 2022. Shweta Rai, Country Division Head (CDH) for Bayer’s Pharmaceuticals Business in South Asia said, “With the introduction of a second brand of Finerenone in India, through our partnership with Sun Pharma, we are advancing Bayer’s commitment of making healthcare accessible to as many patients as possible. India has a high incidence of diabetes and associated renal and cardiac conditions. The true value of innovations like Finerenone can only be fully realized after they reach all deserving patients.” Kirti Ganorkar, CEO - India Business, Sun Pharma said, “We are happy to collaborate with Bayer to provide patients access to a new treatment which s lows down the progression of chronic kidney disease and reduces the risk of kidney failure associated with Type -2 diabetes. This partnership underscores our commitment to make innovative medicines available to patients in India.” The Indian Chronic Kidney Disease (ICKD) study identifies diabetes as the leading cause of chronic kidney disease and end -stage kidney disease in India 1. Over 40% of all patients with diabetes will develop chronic kidney disease2. Over 100 million people suffer from diabetes in India, making it an epidemic. The number of people with diabetes in India is the second highest in the world, after China. Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) progress to kidney failure and premature death. Finerenone is different from the existing treatments for CKD in T2D patients. It acts by selectively blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage. The 2023 American Diabetes Association (ADA) guideline recommends the use of Finerenone for individuals with T2D and CKD with albuminuria treated with the maximum tolerated doses of ACE inhibitors/ARB, to improve cardiovascular outcomes and reduce the risk of CKD progression (level of recommendation A). The pivotal Phase III clinical trial program of Finerenone involving more than 13000 patients globally was undertaken to investigate the safety and efficacy of kidney and cardiovascular outcomes in patients with chronic kidney disease associated with T2DM. The results show that Finerenone significantly reduced the risk of ≥57% Glomerular Filtration Rate(eGFR) kidney composite outcome by 23% on top of optimised Renin -angiotensin system ( RAS) blockade, F inerenone significantly reduced the risk of the composite CV outcome by 14%. Based on the results of the clinical trial studies, Finerenone was approved by the U.S. Food and Drug Administration (USFDA) in July 2021, further granted marketing authorization by the European Commission in February 2022, and subsequently approved in Ind ia by the health authority in April 2022. About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050): Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare product s. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun’s high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, onco-dermatology and accounts for over 16% of company sales. The company’s vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi -cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on Twitter @SunPharma_Live. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com. References: 1. https://academic.oup.com/ckj/article/15/1/60/6352495 2. Indian J Endocrinol Metab. 2015 Jul-Aug; 19(4): 520–523. doi: 10.4103/2230-8210.157857 Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Investors: Media: Dr. Abhishek Sharma Gaurav Chugh Tel +91 22 4324 4324, Xtn 2929 Tel +91 22 4324 4324, Xtn 5373 Tel Direct +91 22 4324 2929 Tel Direct +91 22 4324 5373 Mobile +91 98196 86016 Mobile +91 98104 71414 E mail [email protected] E mail [email protected] Contacts: Bayer Media: Media: Melissa Serrao Edelman India: Desiree Crasto Mobile + 91 98206 82163 Mobile + 91 98195 41498 E mail [email protected] E mail [email protected]

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