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Lipocine And Antares Pharma Enter Into U.S. Licensing Agreement To Commercialize TLANDO®
SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ -- Under the terms of Agreement Lipocine to receive: Up to $21.0 million in licensing fees, including $11.0 million
About this update from Lipocine Inc.
[{"type":"text","content":"SALT LAKE CITY, Oct. 18, 2021 /PRNewswire/ --\n\n \n \n \n \n \n \n\n \nUnder the terms of Agreement Lipocine to receive:\nUp to $21.0 million in licensing fees, including $11.0 million payable immediately and $10.0 million to be paid in the future subject to certain conditions Commercial sales milestone payments of up to $160.0 million Tiered royalties on net sales of TLANDO from mid-teens up to 20% Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of TLANDO in the U.S. Lipocine grants Antares Pharma an option to license TLANDO XR for development and commercialization in the U.S. Upon exercise of the option, Lipocine to receive: An additional $4.0 million in license fees, clinical and regulatory milestone payments of up to $35.0 million, and tiered royalties on net sales from mid-teens up to 20% Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XRLipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States. TLANDO is an oral testosterone product for 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).\nAs previously announced, the U.S. Food and Drug Administration (\"FDA\") granted tentative approval to TLANDO. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO®, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period.\nUnder the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11.0 million and, subject to certain conditions, an additional $5.0 million licensing payment in January 2025 and another $5.0 million lice...