Sun Pharma signs non-exclusive patent licensing agreement with Takeda for introducing Novel Gastrointestinal Drug, Voltapraz (Vonoprazan) in India

Sun Pharmaceutical Industries, (“Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that it has entered into a non-exclusive patent licensing agreement with Takeda Pharmaceutical Company (Takeda) to commercialise Vonoprazan tablets 10 mg, 20 mg in India under the brand name “Voltapraz”.

Vonoprazan is a novel, orally active potassium competitive acid blocker (PCAB), used to treat reflux esophagitis and other acid peptic disorders. 

Under the terms of this agreement, Takeda has granted Sun Pharma non-exclusive patent licensing rights for the commercialisation of Vonoprazan in India.

Commenting on the development, Kirti Ganorkar, CEO – India Business, Sun Pharma said, “Sun Pharma is a leader in Gastroenterology and we are excited to introduce Vonoprazan in India under non-exclusive patent licence from Takeda. This partnership demonstrates our commitment to Gastrointestinal health by providing patients and healthcare practitioners with a novel treatment option to manage reflux esophagitis and other acid peptic disorders.”

Gastroesophageal Reflux Disease (GERD) is common in India irrespective of geographical or rural/urban location (1). Prevalence of GERD in Indian population ranges from 5 per cent to 28.5 per cent. Risk factors for GERD include age, body mass index (BMI), non-vegetarian diet, tea/coffee intake, tobacco, and alcohol consumption. (2)

Previously, in November 2023, Vonoprazan was approved by the U.S. FDA for healing and maintenance of healing of all grades of Erosive esophagitis and relief of heartburn associated with Erosive esophagitis and in combination with amoxicillin and clarithromycin or amoxicillin alone for the treatment of Helicobacter pylori (H. pylori) infection in adults.(3)

Vonoprazan was discovered and developed by Takeda. With a novel mechanism of action, Vonoprazan inhibits the binding of potassium ions to H+ K+ ATPase (proton pump) in gastric parietal cells in the stomach thereby it suppresses basal and stimulated gastric acid secretion (3). 

The drug is approved in India for treatment of adults with Reflux esophagitis and other acid peptic disorders.

References:

1. Bhatia S, Pareek KK, Kumar A, et al. API-ISG Consensus Guidelines for Management of Gastroesophageal Reflux Disease. J Assoc Physicians India. 2020 Oct;68(10):69-80

2. Rai S, Kulkarni A, Ghoshal UC. Prevalence and risk factors for gastroesophageal reflux disease in the Indian population: A meta-analysis and meta-regression study. Indian J Gastroenterol. 2021 Apr;40(2):209-219

3. Vonoprazan tablets Prescribing Information dated November 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215151s000lbl.pdf. Accessed on 07 June 2024