Thursday, October 20, 2022
Sebela Pharmaceuticals® has entered an exclusive partnership with HK inno.N Corporation to license tegoprazan in the United States and Canada. Under the agreement, Braintree Laboratories, a leader in gastroenterology and an affiliate of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing, and sales in the United States and Canada. Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), is currently approved and marketed in several territories, including South Korea and China.
"We are delighted to add tegoprazan to our product pipeline," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "For over 35 years we have been committed to the gastroenterology space and to those affected by GI diseases. Tegoprazan expands our gastroenterology portfolio into an exciting new therapeutic class. Tegoprazan already has an established track record of safety and efficacy in multiple clinical studies and represents a potential new treatment option for people living with GERD."
"We are delighted to partner with Sebela Pharmaceuticals," Dal-Won Kwak, CEO, HK inno.N said in a statement. "Sebela has vast development, regulatory and commercial experience and expertise in the US, having obtained FDA approval and successfully launched multiple gastroenterology products over more than three decades. We believe Sebela Pharmaceuticals is the ideal partner to develop and commercialize tegoprazan in the United States and Canada."
Following successful discussions with the US Food and Drug Administration, Sebela Pharmaceuticals has initiated Phase 3 studies of tegoprazan in patients with gastroesophageal reflux disease (GERD). The Phase 3 GERD program, known as the TRIUMpH program, includes a large, multi-center, double-blind study evaluating the safety and efficacy of tegoprazan versus a PPI control for the indications of healing of all grades of erosive esophagitis (EE) and the maintenance of EE healing and relief of heartburn. The TRIUMpH program also includes a large, multicenter, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of tegoprazan in patients with non-erosive reflux disease (NERD).