Samil Pharmaceutical Signs Exclusive Domestic License Agreement for 'APP13007' with Taiwan's Formosa

Samil Pharmaceutical (CEO Heo Seungbeom) announced on January 13 that it has officially signed an exclusive domestic license agreement with Formosa, a publicly listed Taiwanese pharmaceutical company, for the improved local steroid drug 'APP13007 (clobetasol propionate 0.05%)'.

'APP13007' is the first ophthalmic nano-suspension formulation containing clobetasol propionate, developed using Formosa's APNT® nanoparticle formulation platform. It received FDA approval in the United States in March 2024 for the indication of relieving pain and inflammation following ophthalmic surgeries such as cataract procedures.

In particular, while existing treatments require administration four times a day, 'APP13007' reduces the dosing frequency to twice daily, improving convenience. Additionally, it can be administered for up to 14 days without adjusting the dosage, further enhancing patient compliance.

In two phase 3 clinical trials conducted in the United States (CPN-301, CPN-302), administering 'APP13007' twice daily for 14 days demonstrated rapid and sustained resolution of inflammation (anterior chamber cell count of 0, ACC Count=0) and pain relief (ocular pain grade of 0, Ocular Pain Grade=0) compared to placebo, meeting all primary endpoints. The safety profile was similar to that of placebo, with overall tolerability considered good. Increases in intraocular pressure (IOP) were infrequent and mild, and could be managed without discontinuing the investigational drug.

Through this license agreement, Samil Pharmaceutical has secured exclusive rights to manufacture, promote, distribute, and sell 'APP13007' in South Korea. The license agreement includes an upfront payment upon contract execution, as well as milestone and royalty payments based on product sales after launch.

According to the "2023 Major Surgery Statistics Yearbook" published by the National Health Insurance Service, cataract surgery ranked first in the number of surgeries performed in South Korea in 2023, with a total of 638,000 procedures recorded in that year alone. Given the high frequency of cataract surgeries and the variety of other ophthalmic surgeries performed, the company expects the domestic sales potential for 'APP13007' to be substantial.

Meanwhile, in October 2024, Samil Pharmaceutical's Vietnam subsidiary (a wholly owned subsidiary) and Formosa signed a CMO (Contract Manufacturing Organization) agreement for the global supply of 'APP13007'.

Heo Seungbeom, Chairman of Samil Pharmaceutical, stated, "Through this agreement, we expect to expand treatment options for domestic patients undergoing ophthalmic surgery and further strengthen our competitiveness in the ophthalmology sector. We will systematically proceed with the approval and launch preparations."

Erick Co, President & CEO of Formosa, commented, "We are pleased to expand our partnership with Samil to achieve our shared goal of providing better treatment services to ophthalmic surgery patients in Korea. We will actively support the full realization of 'APP13007's potential through Samil Pharmaceutical's long-standing history and leadership in the ophthalmology field."