Pharma Focus Asia

AriBio Secures Exclusive Marketing Rights for AR1001 to Address Alzheimer's Disease in China Through $770 Million Agreement

Monday, March 25, 2024

AriBio Co., Ltd. (AriBio) recently finalized a substantial contract for AR1001, an investigational drug targeting early-stage Alzheimer’s disease in China, amounting to up to $770 million for exclusive marketing rights.

The agreement entails a non-refundable upfront payment of 120 billion won (approximately US$90 million), with a total potential value reaching 5.59 billion yuan (around US$770 million), including milestone payments and additional royalties. Initial payments are set to commence in mid-2024.

Given the rising number of Alzheimer's cases in China, numerous leading pharmaceutical companies are striving to develop safe and effective oral therapies for the disease. AriBio, having previously partnered with Samjin Pharmaceutical, granting exclusive sales rights worth 100 billion won in South Korea, has extended this collaboration to China, totaling 1.12 trillion won (approximately US$840 million). Considering market competition and strategic considerations for Alzheimer's drugs in China, the licensee has requested confidentiality until an agreed-upon time.

The global Phase 3 clinical trial (Polaris-AD) of AR1001 for patients with early-stage Alzheimer's disease is presently underway in the United States, United Kingdom, and South Korea. Moreover, the trial is awaiting regulatory approval in China and the European Union, with participation planned across 180 locations worldwide. Recruitment of initial patients in the United States is scheduled to commence in December 2022, with other regions actively engaged in recruitment efforts.

Matthew (Jai Jun) Choung, CEO and Chairman of AriBio, expressed confidence in this transaction, highlighting their unwavering dedication to developing effective Alzheimer's treatments. He emphasized the pivotal role of their partners in facilitating the market entry of AR1001 across key Asian regions, with ongoing discussions for potential collaborations in other Asian countries, the Middle East, South America, Europe, and the United States, thus strengthening the AR1001 project.

AR1001, a phosphodiesterase type 5 (PDE5) inhibitor, is being developed as an oral investigational drug for Alzheimer's disease treatment. Preclinical studies have demonstrated its ability to inhibit neuronal apoptosis, restore synaptic plasticity, and exhibit neuroprotective effects. Furthermore, AR1001 has shown significant reduction in hyperphosphorylated tau protein levels in preclinical models and phase 2 clinical trials.

AR1001-ADP3-US01 (NCT05531526) represents a Phase 3 double-blind, randomized, placebo-controlled, multicenter trial, spanning 52 weeks, to assess the efficacy and safety of AR1001 in patients with early-stage Alzheimer's disease. The study aims to evaluate AR1001's potential in slowing disease progression through various cognitive and functional assessments. Detailed information on clinical trials is available at ClinicalTrials.gov.

 

Source: businesswire.com

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