National Treasure Signs Official Domestic License Agreement with RedHill Biopharma for COVID-19 Oral Treatment

[Asia Economy Reporter Jang Hyowon] Kookbo, a KOSPI-listed company, announced on the 15th that it has signed an official license agreement with the US/Israeli biotechnology company RedHill Biopharma for the exclusive commercialization rights of the oral moderate-to-severe COVID-19 treatment Opaganib in South Korea.

Through this agreement, Kookbo will be responsible for the domestic distribution of the oral COVID-19 treatment Opaganib. Along with the product approval-related service contract signed last December with the clinical research organization (CRO) LSK Global Pharma Services, the full-scale progress of the bio business is expected to accelerate.

The payment terms of this license agreement mainly include an upfront payment of $1.5 million to RedHill, milestone payments of up to $5.6 million, and royalties on net sales. Both companies also agreed to extend the first negotiation rights for distribution rights in major Asian regions.

On November 8 last year, Kookbo acquired shares of RedHill Biopharma and was granted the first negotiation rights for distribution contracts covering the domestic and major Asian regional distribution of RedHill’s oral COVID-19 treatment Opaganib, RHB-107 (Upamostat), and Talicia?, a treatment for Helicobacter pylori (H. pylori).

Opaganib, which RedHill is focusing on developing, is the first oral sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and antiviral activity. It targets the host rather than the virus and is expected to be effective against variants including Delta and Omicron, according to the company.

Opaganib has demonstrated improved viral RNA clearance in pre-specified analyses of Phase 2/3 clinical data, significant reductions in mortality and shortened recovery time beyond remdesivir and corticosteroids, and promising Phase 2 data in moderate to severe COVID-19 patients in the US. These data have been submitted for peer review and were recently published on medRxiv.

Additionally, Opaganib has shown strong antiviral activity against SARS-CoV-2, the virus causing COVID-19, inhibiting viral replication of SARS-CoV-2 and its variants tested so far in an in vitro human lung bronchial tissue model. Preclinical in vivo studies demonstrated that Opaganib reduces renal fibrosis, decreases mortality caused by influenza virus infection, and lowers IL-6 and TNF-alpha levels in bronchoalveolar lavage fluid, suggesting potential to improve bacteria-induced pneumonia and lung injury.

Furthermore, Opaganib has received orphan drug designation from the US FDA for cholangiocarcinoma treatment, with ongoing Phase 2a studies for cholangiocarcinoma and Phase 2 studies for prostate cancer. Patient recruitment, treatment, and analysis are currently underway in these studies.

Regarding this license agreement, Dror Ben-Asher, CEO of RedHill, stated, “South Korea is currently experiencing a rapid increase in COVID-19 cases, with approximately 4 million new confirmed cases already added in the first half of March. We are making our best efforts with our partner Kookbo to provide Opaganib to Korean patients who need new COVID-19 treatment options.”

Hyun Ha, CEO of Kookbo, said, “Seeing about 2,000 people hospitalized daily due to COVID-19, I feel the urgent need for effective drugs to treat these patients. Through the data on Opaganib for COVID-19 treatment and the expanded partnership with RedHill, Kookbo will do its best to provide Opaganib to domestic patients as soon as possible.”

This content was produced with the assistance of AI translation services.