Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, and Samil Pharm. Co., Ltd. (Samil) announced the execution of a license agreement  for an exclusive, royalty-bearing license for the commercialization of Aramchol (with an option to manufacture) for the treatment of fatty liver indications including nonalcoholic steatohepatitis, or NASH, in the Republic of Korea, along (the License).

Upon the signing of the agreement, Samil will pay Galmed an up-front fee of approximately $2.0 million. Samil has also agreed to pay additional clinical- and regulatory-based milestone payments, which may aggregate to $6.0 million, as well as tiered, double-digit royalties payable on sales (under certain limitations). The funds provided by this agreement will provide additional financing for Galmed's development programs. Additionally, following the ARREST Study, Samil has an option to extend the license to Vietnam, which, if exercised, would increase the clinical- and regulatory-based milestone payments.

"Samil has a focused, gastrointestinal- and liver-related therapeutic strategy, which represents about one-third of their 2015 annual sales, as well as proven commercialization capabilities in these areas," stated Allen Baharaff, Galmed's president and chief executive officer. Baharaff continued, "Since 2007, we have developed a deep relationship with Samil's executive management and are enthusiastic to ink our first commercial partnership with Samil, and in Asia."

According to Samil and Korean-based key opinion leaders, the prevalence of fatty liver disease in Korea is significant, growing, and of serious medical concern. The prevelence of NAFLD in subjects with diabetes, obesity and dyslipidemia is estimated to range between 25-35 per cent of the high-risk population1. Accordingly, Samil estimates that the addressable market of possible NASH patients in South Korea is between 500,000 to 1,000,0002.

Seung Bum Huh, Samil's president and chief executive officer, added "Our focus on gastrointestinal and liver-related therapeutics is already evident in Korea, and we have every intention to fortify and build our capabilities, and range of drugs in this category even larger going forward." Huh continued, "We have evaluated a host of new therapeutics within the NASH category, and believe that Aramchol fits well into our strategy. "Furthermore, in the NASH space, we also believe Aramchol is uniquely positioned, as it targets the underlying cause of the disease, addresses both the hepatic and metabolic-related issues, and has demonstrated a clean safety profile in its clinical development to date," Huh concluded.

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and it affects almost 30 per cent of adults in Western countries. With climbing obesity rates and more sedentary patient populations, the prevalence of NAFLD is increasing worldwide and is becoming the predominant cause of chronic liver disease in parts of the world. NAFLD represents a spectrum of diseases ranging from simple excess liver fat, or steatosis, to nonalcoholic steatohepatitis (NASH). NASH is the progressive form of fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality in persons who drink little or no alcohol. NASH represents the more severe end of this spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation with or without fibrosis. Long-term risks of NASH include cardiovascular disease, cirrhosis, hepatocellular carcinoma and end stage liver disease requiring liver transplantation.