Seoul: Astrogen Inc., a South Korean clinical-stage pharmaceutical company, announced on Wednesday that it has entered into a $208.5 million agreement with Cigalah Medpharm Trading LLC, a pharmaceutical distributor based in the United Arab Emirates. The deal focuses on the supply of a therapeutic material intended to treat core symptoms of autism spectrum disorder (ASD) across the Middle East and North Africa (MENA) region.

According to Yonhap News Agency, the partnership involves the transfer of technology for Astrogen's lead candidate, AST-001, with plans to commercialize it in 16 countries within the MENA region. Under the terms of the exclusive agreement, Astrogen will supply AST-001 worth $131 million and is set to receive an additional $77.5 million following approval from South Korean authorities to sell the material.

Astrogen submitted the necessary documents to the Ministry of Food and Drug Safety (MFDS) for approval in June of the previous year and anticipates receiving the approval within the first half of this year. Beyond the initial contract payments, Astrogen is poised to earn double-digit royalties once AST-001 is launched in the 16 markets, contingent on regulatory approval from South Korea.

Astrogen's CEO, Hwang Su-kyeong, described the agreement as a significant milestone in the company's global expansion strategy. By collaborating with Cigalah Medpharm, Astrogen aims to expedite the availability of AST-001 to families in the MENA region who are in urgent need of effective ASD treatment options.

Cigalah Medpharm is a part of the Cigalah Group, which ranks among the largest healthcare and consumer product distributors in the Middle East. Yaser Naghi, chairman and CEO of Cigalah Group, emphasized the importance of addressing the unmet medical needs in ASD treatment. He highlighted that the partnership not only introduces a crucial therapeutic option but also enhances the local manufacturing landscape through Alpha Pharma, the group's pharmaceutical manufacturing affiliate.

AST-001 is currently undergoing review as a new drug application (NDA) by the MFDS for the treatment of core symptoms of ASD in pediatric patients. ASD is a complex neurodevelopmental disorder characterized by social communication challenges and restricted, repetitive behaviors.