Pharmaking, "Be reborn as a company specializing in liver disease" Developing non-alcoholic steatohepatitis (NASH)
May 25, 2020, 05:20
Pharmaking, a Korean pharmaceutical company is actively moving to become a company specializing in liver diseases through the development of new drugs. Since 1991, Pharmaking has been introducing treatments for chronic hepatitis patients such as Nissel tablet, UDB capsule and Pennel capsule. On top of that, the company is conducting a new study to develop non-alcoholic fatty liver treatments and plans to introduce them to the market in 2022.
According to research published in Cells and others, fatty liver disease not only causes chronic damage to liver cells but also causes hepatic cell carcinoma itself. A total of 80 Korean companies and global pharmaceutical companies have declared the development of non-alcoholic steatohepatitis (NASH) treatments. The global market for NASH drugs is attracting attention as a "blue ocean" of 40 trillion won a year, but this also proves that it is difficult to develop treatments.
Novartis, Gilead and Big Pharma taste bitter in NASH treatment clinical trials, questions are also raised about the success of Korean pharmaceutical companies, which are inferior in funding. But, Pharmaking is showing confidence to overcome difficulties by using a "different mechanism" from existing treatments.
In August 2019, Phamaking was approved by the Ministry of Food and Drug Safety for phase 3 clinical trials for non-alcoholic steatohepatitis PMK-N01GI1. Oltipraz is an LXR-α regulator that activates an enzyme called AMPK in a morbid state, thereby boosting the metabolic activity of liver cells in the mitochondria to revive cells. Unlike the existing candidate material, which was specifically targeted for steatohepatitis, Oltipraz aims to reduce steatohepatitis levels in patients.
Phamaking plans to invest about 35 billion won in the development of Oltipraz. They have already invested 15 billion won into Phase 2 clinical trials and plans to invest 10 billion won in Phase 3 clinical research. The chances of success are very high because successful commercialization would be the first-in-class product.
Pharmaking plans not to limit Oltipraz's indications to steatohepatitis, but to expand it to hepatocirrhosis by conducting additional clinical trials to expand the symptoms.
"The recent discovery of cases in which liver cancer develops from severe steatohepatitis to liver cancer shows a change in the paradigm of steatohepatitis treatment. Oltipraz is a new concept of treatment that is being developed in line with the new paradigm," said Yang Min-koo, director of the development division of Phamaking. "Pharmaking has been focusing on regular education and new drug development with the company-wide CP Declaration since 2015."
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