Lipocine and Antares Pharma enter agreement to commercialise TLANDO®

pharmafile | October 19, 2021 | News story | Manufacturing and Production  

Clinical-stage biopharmaceutical company, Lipocine Inc, has announced that it has entered an exclusive licensing agreement with Antares Pharma Inc to commercialise TLANDO in the US.

TLANDO is an oral testosterone product for testosterone replacement therapy (TRT) in adult males, indicated for conditions associated with a deficiency or absense of endogenous testosterone: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).

Lipocine is focused on using its proprietary drug delivery technologies to treat metabolic and endocrine disorders, and their clinical development pipeline contains a portfolio of oral testosterone products.

Antares Pharma is primarily centred on the development of self-administered injectable products, using advanced drug delivery auto injector technology. The company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development.

Under the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11 million, and an additional $5 million licensing payment in January 2025, as well as another $5 million in January 2026. These are subject to certain regulatory approvals.

“We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space,” said Dr Mahesh Patel, Chairman, President and CEO of Lipocine. “Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma’s capabilities, given its established marketing experience and demonstrated success in the TRT space.

“Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs.”

The FDA previously granted tentative approval to TLANDO, and the drug will be eligible for final approval in March 2022.

Lina Adams


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