Sun Pharma and Zydus Sign Licensing Agreement for Co-marketing of Desidustat, a Critical Treatment Option for Chronic Kidney Disease Patients in India

Monday, October 30, 2023

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 Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) today announced that both companies have entered into a licensing agreement to co-market an innovative drug, Desidustat in India. Desidustat is first-of-its-kind oral treatment for anemia associated with Chronic Kidney Disease (CKD) in India.

Under the terms of this agreement, Zydus has granted Sun Pharma semi-exclusive rights to comarket the product in India. Sun Pharma will market the drug under the brand name RYTSTAT®. Zydus launched the drug under the brand name Oxemia™ in 2022 and will continue to market it. Zydus will receive upfront licensing income and is eligible to receive milestone income based on achievement of pre-defined milestones.

Commenting on the development, Kirti Ganorkar, CEO - India Business, Sun Pharma said, “The addition of RYTSTAT® further strengthens our nephrology portfolio in India. This partnership will allow greater access to a critical therapy, helping millions of patients suffering from Chronic Kidney Disease. At Sun, it has always been our endeavour to introduce innovative products that help improve the quality of life of patients.”

A spokesperson from Zydus Lifesciences Ltd. said, “Our life changing discoveries are guided by the need to help patients and empower them with therapies that enable them to live healthier and more fulfilled lives. Desidustat, which is one of the critical treatment options for CKD patients, has substantially improved the patients’ quality of life since it is more convenient to take an oral pill instead of an injection that needs to be administered. We are pleased to join hands with Sun Pharma to expand the reach of this novel medicine by enabling access to more patients.”

More than 115 million people in India suffer from CKD, predicted to become one of the most common causes of premature death by 2040 globally.** Patients with CKD often have to battle chronic fatigue caused by anemia. To address this, patients need to take injectable Erythropoiesis Stimulating Agents (ESAs) about twice weekly. There was a long felt need for an oral, safer alternative to ESAs. HIF-PH inhibitors like Desidustat bridge this need. It reduces the burden of managing the disease by providing treatment at an affordable cost along with ease of convenience.

CKD is a serious, progressive medical condition characterized by a gradual loss of kidney function, usually accompanied by other comorbidities including anemia, cardiovascular diseases (hypertension, heart failure and stroke), diabetes mellitus, eventually leading to kidney failure. CKD patients are often on multiple medications and have increased risk of drug-drug interactions. The clinical development programme of Desidustat was one of the largest trials of its kind in India for anemia in CKD patients, conducted in over 1200 subjects. Desidustat provides CKD patients with an oral, convenient therapeutic option for the treatment of anemia.

About HIF-PH inhibitor

Discoveries of how cells sense and adapt to oxygen availability had won the 2019 “Nobel Prize in Medicine”. Desidustat has been designed to inhibit Prolyl Hydroxylase (PHD) activity and stabilize Hypoxia Inducible Factor (HIF) levels in the body. Increased HIF stimulates Erythropoietin (EPO) production and release in the body. Increased HIF decreases hepcidin and improves iron mobilisation. Increased EPO and Iron improves haemoglobin and red blood cells in the body. Desidustat is a Prescription Drug approved in India and can be taken only under the advice and guidance of a Nephrologist or an internal medicine specialist.

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 products. 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 Zydus

Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs nearly 25,000 people worldwide, including 1,400 scientists engaged in R & D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars. For more details visit

www.zyduslife.com

**(http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf).

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