#Brazil #São Paulo #Lipocine #TLANDO #Aché

Lipocine Expands Its Reach with TLANDO® in Brazil

Lipocine Inc., a biopharmaceutical company known for its innovative oral drug delivery systems, has made a significant move by entering into a licensing and supply agreement with Aché Laboratórios Farmacêuitcos S.A. This partnership grants Aché the exclusive rights to market TLANDO® in Brazil, a country where the demand for effective testosterone replacement therapies is surging. With a compound annual growth rate of 34% projected in the Brazilian prescription testosterone market from 2019 to 2023, the timing of this agreement could not be more strategic.

The Significance of TLANDO®

TLANDO® is a testosterone replacement therapy (TRT) that has gained FDA approval in the United States for adult males with conditions indicating a deficiency or absence of endogenous testosterone. This includes primary hypogonadism and hypogonadotropic hypogonadism. Unlike other testosterone therapies available, TLANDO® is designed for oral administration, leveraging Lipocine's proprietary Lip'ral technology to facilitate effective delivery of medications.

“We are thrilled to partner with Aché, a leader within the Brazilian pharmaceutical landscape, to enhance the accessibility of TLANDO® to patients in Brazil,” stated Mahesh Patel, CEO of Lipocine. This partnership opens new avenues for growth, capitalizing on Aché's extensive experience in the local market to navigate the regulatory landscape.

A Promising Partnership

As per the terms of the agreement, Lipocine will receive an upfront payment from Aché and is eligible for further payments contingent on achieving specific regulatory milestones, along with royalties from net sales. Aché will be responsible for managing the regulatory submission and approval process, allowing Lipocine to focus more on innovating within its pipeline of drug candidates.

Aché’s Market Leadership

Aché is a respected name in Brazil's pharmaceutical industry, established nearly 60 years ago, with a mission centered on improving health and enhancing patient quality of life. Their comprehensive portfolio spans generic medicines and over-the-counter products, demonstrating a commitment to advancing healthcare solutions. With over 350 brands that address various therapeutic categories, Aché maintains a strong presence not only in Brazil but also in more than 20 countries across Latin America, Africa, Asia, and Europe.

Moving Forward

This collaboration signifies not only Lipocine's continued commitment to expanding its footprint in international markets but also aligns with its strategy aimed at addressing unmet medical needs through innovative therapies. As TLANDO® becomes available in Brazil, it addresses a largely untapped segment of the TRT market, representing an important opportunity for both Lipocine and Aché.

Lipocine is also exploring various pipelines in development, including treatments for postpartum depression and epilepsy, highlighting the company’s ongoing evolution as a leader in the biopharmaceutical landscape. The company's dedication to effective oral delivery options positions it well within significant markets, particularly for therapies that address pressing health issues.

For more details about TLANDO® and its potential benefits, visit www.TLANDO.com and explore Lipocine's journey in revolutionizing therapeutic solutions.

In conclusion, this agreement not only marks a pivotal step for Lipocine but also signifies a growing recognition of the necessity for accessible therapeutic options in the rapidly evolving healthcare sector of Brazil.