Lipocine Announces License and Supply Agreement for TLANDO® in Brazil

Company Overview - Lipocine Inc. is a biopharmaceutical company focused on effective oral delivery of therapeutics, leveraging its proprietary technology platform [7] - TLANDO is a testosterone replacement therapy approved by the US FDA for adult males with testosterone deficiency, developed using Lipocine's Lip'ral drug delivery technology [4][8] Partnership and Market Opportunity - Lipocine has entered into a license and supply agreement with Aché Laboratórios Farmacêuticos S.A, granting exclusive rights to market TLANDO in Brazil [1][3] - The Brazilian market for prescription testosterone products is substantial, with a compound annual growth rate (CAGR) of 34% from 2019 to 2023, and currently no oral testosterone therapy registered in Brazil [2] Aché's Profile - Aché is a leading Brazilian pharmaceutical company with nearly 60 years of experience, focusing on improving lives through a diverse portfolio that includes prescription medications, generics, and OTC products [5][6] - Aché has over 350 brands and 900 drug presentations across more than 150 therapeutic categories, reaching over 20 countries [6] Financial Terms of the Agreement - Under the agreement, Lipocine received an upfront payment and is eligible for additional payments upon achieving regulatory milestones, as well as royalties on net sales [3] - Aché will handle the regulatory submission and approval process in Brazil, leveraging its established commercial capabilities and regulatory expertise [3]