AriBio said Monday that it has concluded an exclusive distribution agreement with a Chinese pharmaceutical company for AR1001, an oral treatment for Alzheimer's disease, in China. The agreement is valued at about 1.02 trillion won (5.6 billion RMB or $770 million).

Under the exclusive sales contract in China, AriBio will receive an upfront payment of 120 billion won starting in mid-2024 on a schedule to be determined by both parties. AriBio will receive milestone payments for clinical development, approval, and sales royalties.

"This is a definitive agreement with no down payment return," AriBio said. “It signifies the recognition of AR1001's value and marketability overseas."

Commenting on its Chinese partner, the Korean company said, “We will disclose the details of the agreement after a certain time due to ongoing negotiations with multiple countries for distribution rights and a request from the Chinese company considering the fierce market competition and sales strategy for dementia drugs in China."

AriBio also signed a 100 billion won distribution agreement for AR1001 with Samjin Pharmaceutical earlier.

AR1001 is a potent PDE5 inhibitor being developed as a multi-modality oral treatment that can simultaneously target the complex and diverse pathology of Alzheimer's disease. According to AriBio, AR1001 inhibits neuronal death, promotes neurogenesis, activates brain signaling systems, enhances synaptic plasticity, removes toxic proteins, and exhibits good blood-brain barrier permeability.

Dr. Jeffrey Cummings, professor of neurology at Nevada State University and a world-renowned expert in brain diseases, officially recognized AR1001 as an oral Disease-Modifying Therapy (DMP) at the International Conference on Alzheimer's Disease and Parkinson's Disease (AD&PD) 2023 in Lisbon earlier this month.

The global phase 3 clinical trial (Polaris AD) of AR1001 for new drug authorization is enrolling about 1,150 patients. AR1001 has won approval for phase 3 in Korea and has been recruiting and dosing patients since February through the country's first public clinical trial support system. The company recently received phase 3 approval in the U.K. and plans to start dosing patients in seven EU countries, including France and Germany, as well as China in the first half of this year.

"The large-scale distribution agreements in Korea and China are a positive sign for future agreements in Asian countries, the Middle East, South America, Europe, and the U.S.," AriBio CEO Jung Jae-jun said. "With the global phase 3 phase peaking this year and the urgency and importance of dementia treatments with large unmet needs, we will accelerate our efforts to achieve final clinical success, drug approval, and launch."