Lipocine has signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. 

Under the terms of the agreement, Lipocine received an upfront payment from Pharmalink and, upon Marketing Authorizations (MA) in individual GCC countries, Lipocine will provide TLANDO drug products to Pharmalink at an agreed transfer price. Pharmalink will have exclusive rights to TLANDO throughout the GCC region and will be responsible for the promotion, distribution and sale of the product in the territory.

"We are very pleased to partner with Pharmalink to bring TLANDO to the GCC region," said Dr. Mahesh Patel, President and CEO of Lipocine Inc.

"This agreement is aligned with our global strategy to expand the availability of TLANDO and make it broadly accessible.  Pharmalink's expertise and established network in GCC make them an ideal partner to support the adoption and growth of TLANDO in the region," he added.

TLANDO is approved in the United States by the US FDA as a testosterone replacement therapy (TRT) in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

TLANDO was developed using Lipocine's proprietary Lip'ral drug delivery technology platform.