Business
Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada
Lipocine to receive $11 million license feeUp to $259 million in development and commercial sales milestonesTiered royalties on net sales of licensed products
About this update from Lipocine Inc.
[{"type":"text","content":"Lipocine to receive $11 million license feeUp to $259 million in development and commercial sales milestonesTiered royalties on net sales of licensed products up to 18%Commercialization of TLANDO transitions to Verity Pharma effective Feb.1 2024Lipocine retains all rights for territories outside the United States and Canada, and all non-TRT rights globallySALT LAKE CITY, Jan. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), 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.\n\n \n \n \n \n \n \n\n \nUnder 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. \n\"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 ...