Samil Pharmaceutical Extends US Patent Period for Non-Alcoholic Treatment 'Aramcol'

[Asia Economy Reporter Lim Jeong-su] Samil Pharmaceutical announced on the 13th that the new patent for Aramchol, a treatment for non-alcoholic steatohepatitis (NASH), has been registered with the United States Patent and Trademark Office.

Samil Pharmaceutical explained that with this patent registration, the protection period for the low-dose composition patent of the new Aramchol has been extended until June 8, 2036. The previous patent protection period was until December 4, 2034.

Non-alcoholic steatohepatitis, the indication for Aramchol, is often accompanied by metabolic syndrome such as obesity, hyperlipidemia, and diabetes, which are systemic diseases causing abnormalities in fat metabolism. In particular, non-alcoholic steatohepatitis occurs in 20-25% of patients with non-alcoholic fatty liver disease. Unlike simple fatty liver, it is known to progress to cirrhosis and liver cancer due to inflammation and fibrosis progression in the liver.

There are currently no drugs approved by the U.S. FDA (Food and Drug Administration) for the treatment of non-alcoholic steatohepatitis, making it a promising new market. Market research firm GlobalData forecasted that the market size for steatohepatitis treatments will grow to 30 trillion KRW by 2026.

In Korea, the number of new patients is rapidly increasing every year due to the rise in adult diseases such as diabetes and hypertension and the aging trend. According to a prediction based on the 1998-2017 Korea National Health and Nutrition Examination Survey data by Professor Park Hye-soon (Family Medicine) and Professor Kang Seo-young (International Medical Center) at Seoul Asan Medical Center, the obesity rate among adult men in Korea is expected to soar to 65% by 2035. Additionally, the prevalence of non-alcoholic fatty liver, defined as fat accumulation of 5% or more in the liver among this obese population, is expected to increase to 44%.

A Samil Pharmaceutical official expressed, "Non-alcoholic steatohepatitis is a disease with no currently approved new drugs, so if Aramchol receives new drug approval following successful global Phase 3 clinical trial results, it will become a proprietary therapeutic new drug."

Meanwhile, last November, the Israeli company Galmed announced positive results from an open-label clinical trial of Aramchol at the American Association for the Study of Liver Diseases (AASLD), raising expectations for successful new drug development.

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