Aribio said on the 14th that it signed an exclusive licensing agreement with China's Fosun Pharma for the global development, approval, production and commercialization of AR1001, an oral Alzheimer's disease treatment.
The deal is worth up to about $4.7 billion (about 7 trillion won). Aribio will first receive $60 million (about 90 billion won) as an option expense, and will receive an additional $80 million (about 120 billion won) upon the topline announcement of Phase 3. Including these, the total upfront payment comes to $140 million (about 210 billion won). It will then secure milestone revenue and royalties (usage fees) of up to 20% depending on the approval and commercialization stages.
The agreement was signed the day before in Shanghai, China. It is seen as a major technology export transaction surrounding the global business rights to AR1001.
AR1001 is a new drug candidate in the PDE-5 inhibitor class that Aribio is developing as a disease-modifying, oral Alzheimer's treatment. A global Phase 3 trial (POLARIS-AD) with more than 1,500 patients is underway in the United States, Europe, the United Kingdom, China and Korea, and topline results are expected to be announced within the year.
It simultaneously targets amyloid plaques, tau proteins, neuroinflammation, cerebral blood flow and neuroprotection. The company said that clinical data to date have confirmed safety, blood-brain barrier (BBB) permeability and the potential for cognitive improvement in early patient groups.
With this agreement, Aribio said it has secured a global commercialization base ahead of completing Phase 3. Fosun Pharma secured exclusive sales rights for AR1001 in all global markets except Korea, the Middle East and Latin America.
It previously secured rights in China and the Association of Southeast Asian Nations through a license agreement, and on top of that, it bought rights in the United States, Europe and Japan to expand its business scope to the global market. Fosun Pharma said it is also considering a direct investment in Aribio in connection with this deal.
As a result, Aribio's cumulative technology export (exclusive sales rights) agreements amount to about 10 trillion won. Previously, Aribio signed a domestic sales and manufacturing rights agreement (100 billion won) for an Alzheimer's treatment with Samjin Pharmaceutical, and a supply agreement (1.24 trillion won) with Arcera for the Middle East, Latin America, Africa and the CIS.
It separately signed an exclusive sales and manufacturing rights agreement (1.02 trillion won) for the Greater China region (China, Hong Kong and Macao) with Newcopha and Fosun Pharma, and an exclusive sales and manufacturing rights agreement (630 billion won) for 10 ASEAN countries, and this additional agreement with Fosun Pharma has been concluded. In addition, Aribio exported technology for kidney and liver disease treatment candidates under development to Restari in the United States in a deal worth 330 billion won.
Aribio said the agreement reflects both commercial value and development potential.
Jeong Jae-jun, Aribio's co-CEO, said, "This agreement shows that Korea's bio industry can leap to the center of the global new drug market," and added, "We will work together so that AR1001's development can offer patients new treatment opportunities."
Guo Guangchang, chair of Fosun Group, said, "AR1001 is a very special asset in the field of Alzheimer's drug development," and Fosun Pharma Chair Chen Qiqing said, "It has ample potential to be a game changer in the global market." Fosun Pharma will pursue business expansion based on securing global exclusivity.
Meanwhile, Fosun Pharma is a research and development (R&D)-based pharmaceutical and biotech corporations that serves as a core affiliate of the healthcare institutional sector of China's large private investment group Fosun International, founded in 1992 in Shanghai. It is known as a major shareholder of Sinopharm, which holds key drug distribution networks in China. Fosun Group operates a wide range of businesses, including pharmaceuticals and healthcare, tourism, finance, consumer goods and manufacturing, and last year's total sales came to about 32.4 trillion won.