- Sebela Pharmaceuticals® acquires exclusive license rights to develop and market tegoprazan in the United States and Canada

Phase 3 trials with tegoprazan for the treatment of erosive esophagitis and non-erosive reflux disease have been initiated

BRAINTREE, Mass., Oct. 28, 2022 /PRNewswire/ -- Sebela Pharmaceuticals® has entered into 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 a subsidiary of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing and sales in the United States and Canada. Tegoprazan, a new 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 portfolio," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "For more than 35 years, we have been committed to the gastroenterology space and to people affected by gastrointestinal diseases. Tegoprazan expands our gastroenterology portfolio into an exciting new therapeutic class. Tegoprazan already has an established record of safety and efficacy in several clinical studies and represents a potential new treatment option for people living with GERD.

"We are delighted to partner with Sebela Pharmaceuticals," said Dal-Won Kwak, CEO of HK inno.N in a statement. "Sebela has extensive development, regulatory and commercial experience and expertise in the United States, having obtained FDA approval and successfully launched multiple gastroenterology products for more than three decades. We believe that Sebela Pharmaceuticals is the ideal partner to develop and market 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, double-blind, multicenter study evaluating the safety and efficacy of tegoprazan versus a PPI control for the indications for cure of all grades of erosive esophagitis (EE) and maintenance of EE healing and heartburn relief. 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 nonerosive reflux disease (NERD).

About tegoprazan

Tegoprazan is a new agent in development for the treatment of acid-related gastrointestinal diseases. It is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have a rapid onset of action and the ability to control gastric pH for longer periods of time than CAB inhibitors. proton pump (PPI). Tegoprazan has already received marketing authorization in several territories, including South Korea and China.

About GERD

GERD is a highly prevalent and chronic disorder caused by repeated backflow (or reflux) of gastric contents into the esophagus. GERD is characterized by a wide variety of symptoms, including heartburn and acid regurgitation. The main phenotypic presentations of GERD include nonerosive reflux disease (NERD) and erosive esophagitis (EE). EE is usually differentiated clinically from NERD by the presence of mucosal inflammation and lesions in the distal esophagus. Poorly treated EE can lead to Barrett's esophagus, which increases the risk of esophageal cancer. GERD is estimated to affect approximately 65 million people in the United States and 60-70% have NERD. Although proton pump inhibitors are the mainstay of therapy for both EE and NERD, between 35% and 54% of patients do not achieve complete relief of symptoms. This represents a great unmet and underestimated patient need.

About Sebela Pharmaceuticals®

Sebela Pharmaceuticals is an American pharmaceutical company with a leading position in the gastroenterology market and a focus on innovation in women's health. Braintree, part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and marketed a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to more than 320 employees through strategic acquisitions and organic growth.

Visit sebelapharma.com for more information or call tel. 800-874-6756.

About HK inno.N Corporation

HK inno.N is a South Korean public pharmaceutical company that develops, manufactures and markets pharmaceutical products for the domestic and international market. HK inno.N's key businesses are in the areas of prescription drugs, health supplements and beauty products. Since its establishment in 1984, through exports and global alliances, the company is becoming an international pharmaceutical firm. Based on the company's experience and expertise in novel drug development, HK inno.N succeeded in launching the new GERD treatment 'K-CAB®' (Tegoprazan), the 30th novel drug developed and registered in Korea, with great success. For more information, please visit https://www.innon.com/eng.

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