Japanese pharma firm permits commercialisation of GI drug in India

Japan-based Takeda Pharmaceuticals has entered into non-exclusive patent licensing agreements to commercialise Vonoprazan 10 mg and 20 mg tablets with Indian counterparts Sun Pharma and Cipla. The Japanese company had earlier this month entered into a similar agreement with another Indian company based out of Ahmedabad, Torrent Pharmaceuticals.

Vonoprazan is a novel oral active PCAB tablet consumed for the treatment of Gastroesophageal Reflux Disease (GERD) and other multiple gastrointestinal conditions such as erosive oesophagitis, duodenal, and peptic ulcers.

“GERD is common in India irrespective of geographical or rural/urban location. The prevalence of GERD in the Indian population ranges from 5% to 28.5%. Risk factors for GERD include age, body mass index (BMI), non-vegetarian diet, tea/coffee intake, tobacco, and alcohol consumption,” informed the Sun Pharma press release. A 2019 study by the Indian Journal of Gastroenterology revealed the prevalence of the disease of around 11.1% in urban populations to be higher than the national average.

“According to AWACS MAT April 2024 data, the Indian market for treatments used in GERD is valued at Rs 8,064 crore, growing at 8% CAGR over the last four years,” revealed the press release issued on June 5 by Torrent Pharma. “As of now, proton pump inhibitors such as pantoprazole are the treatments used for GERD,” the release added.

Vonoprazan is majorly for treating acid-related illnesses among patients in the Indian market. Cipla will commercialise the drug in India under its trademark brands. Torrent Pharma, like Cipla, plans to market Vonoprazan under its trademark, Kabvie. Sun Pharma will be commercialising the drug under the brand name “Voltapraz”.

Mr. Achin Gupta, CEO of One India Business, Cipla Limited, said, “Bringing new and advanced therapies to the Indian market has always been a key area of focus for us. We believe this partnership will not only address a significant medical need but also strive to provide a better quality of life for patients.”

As of today, shares of Sun Pharma, Cipla, and Torrent have been trading positively on the NSE with all three growing at below 1%.

These pharmaceutical companies have entered into various licensing agreements in recent years. Sun Pharma for instance has signed agreements for marketing and commercialization with a variety of international pharmaceutical manufacturers including Bayer for its patented medicine for a chronic kidney disease associated with type 2 diabetes mellitus, Zydus for comarketing its oral treatment for anaemia associated with Chronic Kidney Disease (CKD) and Pharmazz Inc. for treating cerebral ischemic stroke.

“Sun Pharma is a leader in Gastroenterology and we are excited to introduce Vonoprazan in India under a non-exclusive patent licence from Takeda,” Kirti Ganorkar, CEO of India Business, commented on the development.

Vonoprazan was discovered and developed by Takeda. The GI drug received approval from the US FDA in November 2023 for the healing and maintenance of all grades of Erosive esophagitis and of heartburn associated with Erosive esophagitis and for the treatment of H. pylori infection in adults.

The drug has been approved in India for the treatment of adults as well.