● Ongentys Capsule, SK chemicals’ Parkinson＇s Disease Treatment Obtains Marketing Approval in South Korea

- A new drug called “Ongentys Capsule” is introduced in Korea to treat Parkinson＇s disease with motor fluctuation symptoms
- Received marketing approval in Europe in 2016, and approval expected in the US and Japan by 2020


SK chemicals has received marketing approval to start supplying a new drug for Parkinson＇s disease patients with motor fluctuation in South Korea.

SK chemicals (CEO Jeon Kwang-hyun) announced on the 28th that it has obtained a marketing license for the domestic supply of Ongentys (ingredient name: opicapone), a drug for Parkinson＇s disease developed by BIAL, the largest pharmaceutical company in Portugal.

SK chemicals and BIAL had signed a license agreement in February 2018 for the exclusive supply of Ongentys in South Korea. Ongentys capsule, a new drug for treating Parkinson＇s disease, will be officially supplied in the second half of next year for the first time in South Korea.

Ongentys capsule, for which SK chemicals has obtained a license, is administered to patients with Parkinson＇s syndrome who have motor fluctuation that does not improve with the administration of levodopa/dopa-decarboxylase inhibitors. It inhibits the breakdown of levodopa in the bloodstream and prolongs the effect to improve symptoms.

Generally, patients with Parkinson＇s disease who lack dopamine, a neurological substance in the brain, are given levodopa to supplement dopamine levels. However, long-term use of levodopa may cause symptoms of motor fluctuation such as shorter drug effects and slow body movements before taking the next dose.

Ongentys significantly improved off-time (the time when it is impossible or difficult for the patient to move) compared to placebo through a mechanism that increases the rate of being transferred to the brain by suppressing levodopa decomposition in peripheral nerves, in two Phase III clinical trials conducted by the original developer, BIAL, in more than 1,000 subjects in 30 countries, including Europe and Korea.

Approved by the European Medicines Agency (EMA) in June 2016, Ongentys was launched in five European countries, starting its first commercialization in Germany and the UK, and then in Spain (2017), Portugal and Italy (2018).

According to IQVIA’s MIDAS, a pharmaceutical sales database, it is rapidly expanding its market, accounting for 38% and 51% of market shares in Portugal and Italy, and continues to grow, accounting for 43% and 26% of market shares in Spain and Germany, respectively.

In addition, the drug is actively entering the global market by applying for a marketing license through local partners in the US and Japan this year and marketing approval is anticipated in the first half of next year.

Kim Jung-hoon, head of the SK chemicals R&D Center, said, "We＇ve expanded the options for patients by supplying a new drug that will improve motor fluctuation, a typical symptom in Parkinson＇s patients,” and he added, “We want to contribute to the national health by strengthening our portfolio of central nervous system drugs.”

According to data from the Korea Health Insurance Review and Assessment Service, about 110,000 people in Korea were suffering from Parkinson＇s disease as of last year, and the anti-Parkinson drug market amounted to 76.7 billion won according to IQVIA.


* Photo : SK chemicals has obtained a marketing license for the domestic supply of “Ongentys Capsule,” a drug for Parkinson＇s disease developed by BIAL, the largest pharmaceutical company in Portugal. (Ongentys 50mg product design for sale in Europe)