Lipocine announces license agreement for TLANDO in the U.S.

Lipocine, Gordon Silver and Verity Pharmaceuticals announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO in the U.S. and, if approved, in Canada. TLANDO is the first and only oral testosterone replacement therapy, or TRT, option approved by the 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, 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 $11M with an initial payment of $2.5M which was received on signing of the License Agreement, $5M to be paid on February 1, $2.5M to be paid no later than January 1, 2025, and $1M to be paid no later than January 1, 2026. Lipocine will be entitled to receive up to $259M 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.