Lipocine, a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada.

TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration. The agreement also provides Verity Pharma with the U.S. and Canadian rights to develop and commercialize LPCN 1111 (TLANDO XR), a next generation, once daily oral product candidate for TRT.

Under the terms of the agreement, Lipocine will receive from Verity Pharma a license fee of $11 million with an initial payment of $2.5 million which was received on signing of the License Agreement, $5 million to be paid on February 1, 2024, $2.5 million to be paid no later than January 1, 2025, and $1 million to be paid no later than January 1, 2026.

Lipocine will be entitled to receive up to $259 million in development and sales-based commercial milestone payments, as well as tiered royalty payments at rates ranging from 12% up to 18% on net sales of TLANDO franchise products.  Under the agreement, Verity Pharma will be responsible for regulatory and marketing obligations in the U.S. and Canada, and all further development.  Lipocine retains all rights to the TLANDO franchise for territories outside the U.S. and Canada, and all rights to non-TRT indications globally.

“We are very pleased to enter this license agreement with Verity Pharma. Men’s health is one of Verity Pharma’s areas of focus and Verity Pharma’s sales force has existing relationships with men’s health prescribers. Verity Pharma is highly motivated and has the capabilities and expertise to successfully grow the TLANDO franchise without interruption in patient access to TLANDO,” said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. “This transaction will further enable Lipocine’s strategy to focus on developing treatments for CNS disorders and to add value to our non-core assets.”