SEOUL, South Korea and MEXICO CITY, Mexico, June 5, 2024 – Autotelic Bio, a leading innovator in novel drug development, today announced an exclusive license and supply agreement with Chinoin Productos Farmaceuticos, a prominent Mexican pharmaceutical company, for the distribution of ATB-101, a groundbreaking combination therapy for the simultaneous treatment of hypertension and diabetes. The announcement was made at the 2024 Bio International Convention held in San Diego, USA.

ATB-101 is the world's first combination drug formulated with olmesartan, a hypertension treatment, and dapagliflozin, an oral diabetes medication. This novel therapy is designed to enhance the convenience of patients suffering from both chronic conditions by combining treatment into a single medication. ATB-101 has received IND approval for Phase 3 clinical trials from the Korean Ministry of Food and Drug Safety and is currently being tested in approximately 35 major hospitals across South Korea.

Autotelic Bio plans to prove the safety and efficacy of ATB-101 through ongoing Phase 3 trials and aims for a global launch. The company has secured composition patents in the Republic of Korea, United States, Mexico, Brazil, Russia, and Japan, and plans to expand to additional countries, including China.

This agreement with Chinoin involves the supply of over 30 million tablets of ATB-101 over five years, marking a significant step towards penetrating the Latin American market and laying the groundwork for global expansion. Autotelic Bio will receive milestone payments throughout the development and approval stages of ATB-101, in addition to the upfront payment.

Market Potential in Mexico

Mexico's hypertension and diabetes market is the second-largest in Latin America, following Brazil, demonstrating significant growth potential. Autotelic Bio intends to reinvest revenue generated from the Mexican market into ongoing innovative drug research and development. 

established in 1924, is a leading pharmaceutical company in Mexico, known for its robust R&D, production, regulatory, and marketing capabilities. Over the past decade, Chinoin has achieved top 10 sales records in Mexico's prescription market. Their strong sales and marketing proficiency is complemented by their significant market presence across Central America, South America, and other Latin American regions.

U.S. Market Prospects

Autotelic Bio recently completed a Pre-IND meeting with the U.S. FDA, receiving positive feedback on their ongoing Phase 3 clinical trials. The FDA has indicated that local Phase 1 trials will suffice to leverage South Korea's Phase 3 results for U.S. approval. As a result, Autotelic Bio engaged in over ten meetings with pharmaceutical companies at Bio USA to discuss global licensing for ATB-101, including potential U.S. rights. 

The company is also part of the K-Blockbuster Global Initiative by the Korea Health Industry Development Institute (KHIDI), establishing a presence in Boston's C&D Incubation Office to strengthen its network and accelerate clinical development and licensing efforts in the U.S.