Ahmedabad-based Zydus Lifesciences Limited has secured a non-exclusive patent licensing agreement with Takeda Pharmaceutical Company to market the novel Potassium Competitive Acid Blocker (P-CAB) Vonoprazan in India. This agreement, announced on July 17th, grants Zydus the rights to market Vonoprazan for the treatment of gastroesophageal reflux disease (GERD) in India. The drug will be marketed under the brand name Vault.
Zydus Lifesciences, formerly known as Cadila Healthcare Limited, has a long history of providing innovative gastrointestinal therapies in India. The company’s Managing Director, Dr. Sharvil Patel, stated that they have been offering groundbreaking clinical options in this area for many years and are committed to providing access to new treatment options and innovative healthcare solutions. The addition of Vault to their existing portfolio of gastro therapeutic products will expand their range of treatments for acid peptic disorders.
Vonoprazan boasts a novel mechanism of action. It inhibits the binding of potassium ions to H+K + ATPase (proton pump) in parietal cells of the stomach, thereby suppressing both basal and stimulated gastric acid secretion. The drug has been approved in India by the Drugs Controller General of India (DCGI) for the treatment of adults with Reflux esophagitis and other Acid Peptic Disorders (APD).
Gastroesophageal Reflux Disease (GERD) is a prevalent condition in India. Studies, such as one published in the Indian Journal of Gastroenterology in 2021, have reported a pooled prevalence of GERD in the Indian population of 15.6%. Factors like age, body mass index (BMI), diet, tea/coffee intake, tobacco, and alcohol consumption have been identified as risk factors.
Zydus has a proven track record of introducing innovative treatment options for GERD, with previous offerings including Pantodac (Pantoprazole), Happi (Rabeprazole), and Ocid (Omeprazole). Notably, Zydus was the first company to introduce Pantoprazole in India back in 1999. The launch of Vault (Vonoprazan) will provide clinicians with a new treatment option to manage GERD and other acid peptic disorders for the Indian population.
This agreement comes amidst recent legal developments concerning Zydus Lifesciences. Last week, the Delhi High Court issued an order prohibiting the company from marketing Sigrima, a biosimilar to Roche’s Pertuzumab (brand name Perjeta), a medication for breast cancer. This ruling stemmed from a patent infringement lawsuit filed by Roche against Zydus and Dr. Reddy’s Laboratories.
