• Department of Health (DoH) of Hong Kong approved AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older
• Follows recent approval from China’s National Medical Products Administration (NMPA)

Santhera Pharmaceuticals (SIX: SANN) announcesthat the Department of Health of Hong Kong, China, has approved AGAMREE® (vamorolone) for use in patients aged 4 years and older.

The approval by the DoH of Hong Kong constitutes the fifth independent approval by local health authorities after the US FDA, EMEA, MHRA and the NMPA and will allow patients with DMD in Hong Kong access to AGAMREE in the near future.

According to the license agreement between the companies first announced in January 2022, Sperogenix holds exclusive rights for the development and commercialization of AGAMREE for DMD and other rare disease indications in Greater China. This agreement was amended in March 2023 to include the option for several additional Southeast Asian countries, namely Brunei, Cambodia, Timor-Leste (East Timor), Indonesia, Laos, Malaysia, Myanmar (Burma), the Philippines, Singapore, Thailand, and Vietnam in exchange for a USD 4 million payment by Sperogenix. Sperogenix exercised this option in July 2024 to include these territories in their license agreement. Santhera is supplying AGAMREE to Sperogenix for both the ongoing Early Access Program (EAP) and for commercialization. Sperogenix will pay Santhera royalties at a double-digit percentage on net product sales, along with additional revenue-dependent milestones based on commercial sales.