이 기사는 2021년 12월 27일 08:13 thebell 에 표출된 기사입니다.

South Korea’s HK inno.N singed an out-licensing deal worth $540 million with Braintree Laboratories to commercialize its gastroesophageal reflux disease (GERD) treatment K-CAB (tegoprazan) in North America, the company announced on Thursday.

Braintree Laboratories is a subsidiary of Sebela Pharmaceuticals, a US specialty pharmaceutical company specializing in gastrointestinal health. The agreement marks the largest-ever out-licensing deal by the South Korean healthcare company to date.

HK inno.N will receive an upfront cash payment of $2.5 million – or only 0.5% of the total deal value – seemingly a small amount given 100 billion won ($84 million) of out-of-hospital prescription revenue expected to be generated by the drug this year in the domestic market.

The terms of the deal appear to reflect the US GERD drug market which is worth 20 trillion won a year, industry watchers said. The market is currently dominated by proton pump inhibitor (PPI) therapy. But many expect potassium-competitive acid blocker (P-CAB) drugs, like K-CAB, to become an alternative to PPIs as they offer higher efficacy and easier dosing.

There is no P-CAB drug launched in the US. Other pharmaceutical companies developing P-CABs include Japan’s Takeda Pharmaceutical, which out-licensed its P-CAB drug vonoprazan to Phathom Pharmaceuticals to commercialize it in the US.

In October this year, Phathom announced the topline results for the phase 3 clinical trial of vonoprazan, widening a gap with K-CAB which received approval for the phase 1 clinical trial from the US Food and Drug Administration in 2020.

Phathom plans to submit an application with the FDA in 2022 seeking approval for marketing in the US, raising expectations that its vonoprazan product could be first in class.

“P-CAB drugs are generally more expensive than PPIs, and this disadvantage should be overcome by showing that they can provide much higher efficacy,” an industry insider said.

Apart from the $2.5 million upfront payment, HK inno.N will receive $537.5 million in future milestone payments plus tiered royalties for commercialization. Development costs for the clinical trial in the US will be borne by Braintree Laboratories.

“With this licensing deal with Braintree Laboratories, we will continue efforts such as changing dosage forms to expand the market share of our P-CAB drug,” an official at HK inno.N said. (Reporting by Eun-su Choi)