Medicox Signs Distribution Contract for Convenient Oral Insulin... Targeting 1.5 Trillion Insulin Market

[Asia Economy Reporter Jang Hyowon] Medicox announced on the 14th that it has signed an exclusive domestic distribution contract through licensing for the oral insulin for type 2 diabetes 'ORMD-0801,' which is in Phase 3 clinical trials with the U.S. Food and Drug Administration (FDA), with Israeli pharmaceutical company Oramed Pharmaceuticals (hereinafter Oramed).

According to the Health Insurance Review and Assessment Service, the number of type 2 diabetes patients in South Korea has steadily increased from 2,517,443 in 2017 to 3,206,932 in 2021. Among them, the insulin treatment rate is about 6.4%, with a market size of approximately 1.5 trillion KRW.

Looking at the prevalence of diabetes in people over 30 by country according to the World Health Organization, Chile is 11.4%, Japan 10.1%, South Korea 9.4%, the United States 9.1%, Germany 7.4%, and Australia 7.3%, while the global average is 4.7%. Considering this, South Korea shows nearly double the global average diabetes prevalence.

According to a 2018 survey by the Korea Disease Control and Prevention Agency, the prevalence of diabetes among those over 30 in South Korea was 14.4%, about 5% higher than the WHO survey results. The prevalence rate is slightly higher in men than in women.

The contract terms between Medicox and Oramed include an upfront payment of 2 million USD (approximately 2.8 billion KRW) and milestone technology fees up to 18 million USD (approximately 25.6 billion KRW), with a contract period of 10 years from the date of approval for sale by the Ministry of Food and Drug Safety of Korea.

Oramed is also focusing on the large Korean insulin market. Nadav Kidron, CEO of Oramed, stated, “It is known that one in seven Koreans over 30 has diabetes. This contract provides Oramed with a great opportunity to enter the Korean diabetes market. Medicox, our partner in Korea, will achieve good results, and Oramed will be able to focus its capabilities on other major markets including the United States outside Korea.”

Medicox CEO Oh Daehwan said, "Once clinical trials are completed and full-scale sales begin, Medicox will exclusively distribute oral insulin for diabetes domestically," adding, "We are confident that the oral insulin 'ORMD-0801' will be a game changer in the domestic diabetes treatment market worth 1.5 trillion KRW, which includes not only existing insulin but also type 2 diabetes treatments."

Oramed has been developing oral insulin since 2006 and completed patient enrollment for the world's first Phase 3 clinical trial in May. Currently, patients at 96 clinical research sites across the United States are taking oral insulin, with efficacy in blood glucose control compared against placebo. The clinical results are expected to be announced in the first half of 2023.

In September, Oramed announced positive topline results from the FDA Phase 2 trial of oral insulin (ORMD-0801) for non-alcoholic steatohepatitis (NASH). Future research and development with Medicox is also expected to lead to entry into the fatty liver disease treatment market.

Meanwhile, as part of this contract, Nadav Kidron, CEO of Oramed, is reportedly coordinating a visit to South Korea with Medicox. During this visit, an investor briefing session will be held, inviting domestic medical professionals and investment experts to introduce the business related to oral insulin.