"Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, ""Sun Pharma"" and includes its subsidiaries and/or associate companies) today announced that it has launched Fexuprazan tablets 40 mg in India under the brand name “FEXUCLUE®”. FEXUCLUE®, a novel potassium- competitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades.
Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd, Korea, a biopharmaceutical company, to manufacture and commercialise FEXUCLUE®(Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties.
Kirti Ganorkar, CEO – India Business, Sun Pharma, said, ""Erosive Esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management. FEXUCLUE® is a best-in-class treatment option with the potential to bridge this gap. At Sun Pharma, we are committed to introducing innovative medicines that enhance patients' quality of life.""
Fexuprazan was evaluated in a double-blind, double-dummy, comparative Phase 3 study in adult Indian population. The primary efficacy measure was healing of Erosive Esophagitis which was confirmed endoscopically. The study met its primary endpoint. Over 95% of the patients achieved Erosive Esophagitis healing by 8 weeks. Fexuprazan was found to be well tolerated in Indian patients.
Erosive esophagitis is a condition characterized by inflammation and damage to the lining of the esophagus . Erosion or breaks in lining of esophagus due to chronic irritation are typically observed in erosive esophagitis. Most common cause for erosive esophagitis is the chronic irritation due to reflux of stomach content into esophagus known as gastroesophageal reflux. Erosive esophagitis is considered as a type of gastroesophageal reflux disease (GERD) which is commonly associated with symptoms such as heartburn and regurgitation.i,ii The prevalence of GERD in India varies from 7.6% to 30% and erosive esophagitis occurs in almost 9% of GERD patients.iii Despite the availability of medical, endoscopic, and surgical therapy, still many patients of erosive esophagitis fail to achieve healing of erosions and symptom relief and suffer from impaired quality of life.iv
Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma’s high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% 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 multicultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on LinkedIn & X (Formerly Twitter).
Daewoong Pharmaceutical is one of Korea's leading healthcare companies with outstanding new drug development capabilities. Since launching its first new drug, EasyF Solution in 2001, Daewoong has succeeded in developing various new drugs, including the GERD treatment Fexuprazan in 2022 and the SGLT-2 inhibitor diabetes drug Enavogliflozin in 2023