This file photo provided by Astrogen Inc. shows the manufacturing company’s headquarters in Daegu, 310 kilometers south of Seoul. (Yonhap)
SEOUL, Jan. 7 (Korea Bizwire) – Astrogen Inc., a South Korean clinical-stage pharmaceutical company, said Wednesday it has signed a US$208.5 million deal with a Middle Eastern company to supply a therapeutic material for treating the core symptoms of autism spectrum disorder (ASD).
The partnership with United Arab Emirates-based pharmaceutical distributor Cigalah Medpharm Trading LLC aims to transfer technology for Astrogen’s lead candidate, AST-001, and commercialize it in 16 countries across the Middle East and North Africa (MENA) region, the company said in a press release.
Under the exclusive agreement, Astrogen will supply AST-001 worth $131 million and receive an additional $77.5 million upon receiving approval from South Korean authorities to sell the material, it said.
Astrogen submitted documents to the Ministry of Food and Drug Safety (MFDS) for approval in June last year and expects to obtain the approval in the first half of this year.
In addition to the contract payments, Astrogen is expected to receive double-digit royalties once sales of AST-001 begin in the 16 markets following regulatory approval in South Korea.
“This agreement is a transformative milestone in Astrogen’s global expansion strategy. By leveraging Cigalah’s regional capabilities and expertise in local manufacturing, we aim to accelerate the availability of AST-001 to families in the MENA region who urgently need effective treatment options for ASD,” Astrogen Chief Executive Officer (CEO) Hwang Su-kyeong said.
Cigalah Medpharm is part of Cigalah Group, one of the largest health care and consumer product distributors in the Middle East.
“ASD remains an area with significant unmet medical need, and Astrogen’s AST-001 represents a promising advancement in this field,” Yaser Naghi, chairman and CEO of Cigalah Group, said. “This partnership not only enables us to deliver an important new therapeutic option but also strengthens our local manufacturing ecosystem through Alpha Pharma,” the group’s pharmaceutical manufacturing affiliate.
AST-001 is an investigational drug candidate currently under new drug application (NDA) review by the MFDS for the treatment of core symptoms of ASD in pediatric patients.
ASD is a complex neurodevelopmental disorder involving social communication deficits and restricted, repetitive behaviors.
(Yonhap)
