inno.N said the company has licensed out its gastroesophageal reflux disease (GERD) therapy, K-CAB, to Braintree Laboratories, a subsidiary of Sebela US, a U.S.-based pharmaceutical company.

The total contract size is 640 billion won ($540 million), the largest single contract achieved by the company for K-CAB.

Under the accord, inno.N will receive a down payment of $2.5 million, technology fees for each clinical and licensing progress stage, and royalties according to sales. The contract term is 15 years after commercializing the product in the U.S., and inno.N will also supply raw materials for K-CAB to Braintree Laboratories.

Only proton pump inhibitors (PPI)-type gastroesophageal reflux disease drugs are currently in the U.S. market.

However, patient groups with severe heartburn symptoms or severe esophageal mucosal damage who show little efficacy toward PPI products account for about 40 percent of all U.S. gastroesophageal reflux disease patients, which has, in turn, led to a high unmet medical need for a new treatment.

Therefore, P-CAB treatments have recently received spotlighted as a new solution as they are a next-generation product.

As K-CAB is a P-CAB product, inno.N expects to help address the unmet medical demand in the U.S. gastroesophageal reflux disease treatment market, as it has already verified its competitiveness and marketability in Korea.

The company plans to utilize various clinical research data that the drug has steadily accumulated since its launch to gain an edge in the U.S. market.

"We are pleased to license out K-CAB, which is a locally developed drug K-CAB, to the U.S., the world's largest market," inno.N CEO Kang Seok-hee said. "As K-CAB will be launched in major countries starting with China next year, we hope that K-CAB will aggressively expand its market share based on its success in Korea."

Kim Bo-hyun, head of the K-CAB business and development marketing team, also said, "The goal is to export K-CAB to 100 countries by 2028, including Europe."

The company will further strengthen the global status of the blockbuster drug K-CAB through research on indications expansion, differentiated clinical trials, and the development of various formulations, Kim added.

inno.N has introduced K-CAB to 27 countries, including the recent U.S. technology export contract. The total export fee that K-CAB has accumulated in major countries amount to 1 trillion won. Among the exported countries, the drug is in the final stage of approval for a Class 1 new drug in China, and the company expects to launch the drug in the first half of next year.

K-Cab became Korea's 30th novel drug in 2018. It is the first potassium-competitive acid blocker (P-CAB) to obtain the indication for EE(Erosive esophagitis) and NERD(Non-erosive reflux disease) GERD in Korea.

According to the company, while conventional treatments, such as proton pump inhibitors (PPI), need three to five days to show efficacy, P-CAB drugs suppress gastric acid secretion in just one hour. P-CAB treatments also inhibit excessive secretion of gastric acid during nighttime, reducing chest pain and a sleep disorder, it said.