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  • Suganon, a new domestic drug that is evolving
  • by An, Kyung-Jin | translator Choi HeeYoung | Sep 23, 2020 08:06pm
This year's cumulative sales of ₩16 billion, a new record in annual sales forecast
Completed release of India and Russia, speed of entry into overseas markets such as Brazil
Promoting the development of new indications such as aortic heart valve calcification
 ▲ Suganon
Suganon (Evogliptin), a diabetes treatment developed by Dong-A ST's proprietary technology, has stepped up its competitiveness. Despite the return of rights, efforts are being made to improve the value of new drugs while seeking new indications. The growth of domestic sales has gained momentum, and it is advancing into overseas markets by completing sales in India and Russia.

According to Dong-A ST on the 23rd, the cumulative sales of two types of Suganon and Sugamet this year were ₩16 billion, which doubled from the same period last year. This is the figure calculated based on the company's own shipments from January to August this year. In eight months, the company announced a new record in annual sales, surpassing ₩14.2 billion in sales last year.

Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. It has a mechanism of action that inhibits insulin-secreting hormone-degrading enzyme (DPP-4). Dong-A ST entered the domestic DPP-4 inhibitor market with the release of Suganon in March 2016. In May of the same year, it launched Sugamet, a combination drug that combines Metformin with Suganon, and is in fierce competition with competitors.

Suganon and Sugamet had difficulty in securing market share at the beginning of their release as they entered the market as the latest among the nine DPP-4 inhibitors sold in Korea, but their market influence is steadily increasing. From mid-2018, the third year of its release, its quarterly sales exceeded ₩3 billion, and since the second quarter of last year, it has become the company's flagship item by breaking the record for quarterly sales. It is analyzed that the fact that the high selectivity to DPP-4 enzyme is high and that it has little effect on the metabolism of other drugs was actively appealed, and that the reliability of medical staff increased as the prescription experience in the treatment field was accumulated.

 ▲ Quarterly sales of Suganon and Sugamet (Unit: ₩100 million, Source: Dong-A ST)

Suganon will also enter the overseas market. Dong-A ST has signed technology transfer contracts with many global pharmaceutical companies, including India and Nepal in December 2012, Brazil in 2014, 17 countries in South America and 3 countries in the CIS (Commonwealth of Independent States) including Russia in 2015. After signing a contract with Alkem, an Indian pharmaceutical company in 2012, it completed the sale of Suganon in India in March of last year, after obtaining approval for sale from the Drug Controller General of India (DCGI) in December 2018 and March 2019. It also started sales in Russia through Geropharm, a Russian pharmaceutical company that it had a relationship with in 2015. Entering this year, it applied for a new drug license (NDA) for Suganon to a Brazilian regulatory agency, and 17 countries in South America are also undergoing national development and approval procedures.

Dong-A ST is also focusing on developing a new market for Suganon. It was exported to the US pharmaceutical company Tobira Therapeutics in 2016 for a technology export of 61.5 million dollars, and returned it after 1 year and 6 months, and the goal of developing a treatment for non-alcoholic steatohepatitis (NASH) was failed. This is because Tobira's R&D strategy changed as it was acquired by a large global pharmaceutical company Allergan.

 ▲ Suganon

In January of last year, Dong-A ST signed a technology transfer contract with Rednvia for the development and sale of aortic heart valve calcification treatment for Suganon and began development. Rednvia is a joint venture established by transferring technology to a substance patent for Suganon, a diabetes treatment drug developed by Dong-A ST, and a patent for aortic heart valve calcification treatment at Asan Medical Center.

Rednvia began its global clinical development step in earnest by receiving approval from the US Food and Drug Administration (FDA) for a local Phase IIb/IIIa clinical trial plan (IND) that evaluates the efficacy and safety of Suganone in treating aortic heart valve calcification. Researchers from renowned medical institutions in the United States such as the Mayo Clinic and Massachusetts General Hospital have confirmed their participation, reflecting the high interest of the treatment field.

Rednvia has been conducting phase II clinical trial in 225 patients with aortic valve calcification in Korea since last year. The goal is to accelerate the commercialization of products as much as possible by receiving clinical research funding from the National Institutes of Health (NIH) while simultaneously operating both Korean and US clinical trials. Since there is no officially licensed treatment for aortic heart valve calcification, and it has to rely entirely on surgery, it is expected that if Suganon succeeds in commercialization, it will have high marketability.

Rednvia is also re-challenging for NASH indications, which were once frustrated. In order to develop a combination drug that targets fibrosis in NASH patients, it is examining the discovery of candidate substances that can create synergy with Suganon.
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