Lipocine (NASDAQ:LPCN) Enters Distribution and License Agreement with SPC Korea for TLANDO Therapy

On October 28, 2024, Lipocine Inc. (NASDAQ: LPCN) announced the signing of a Distribution and License Agreement with SPC Korea (‘SPC’) to commercialize the company’s TLANDO® product. The agreement aims to focus on testosterone replacement therapy for males dealing with conditions related to a deficiency or absence of endogenous testosterone. This includes treatment for Klinefelter syndrome, as well as pediatric indications concerning testosterone replacement therapy.

The Distribution and License Agreement, also known as the “SPC License Agreement,” involves the commercialization of TLANDO under a New Drug Application (NDA) No. 208088 in a specific therapeutic area. As part of this announcement, Lipocine issued a press release confirming the agreement, which is detailed in Exhibit 99.1 of the company’s recent SEC filing.

Under the terms of the agreement, Lipocine stands to receive an upfront payment, along with potential regulatory and sales milestone payments, which includes a payment upon the regulatory approval of TLANDO in South Korea. Furthermore, Lipocine will benefit from royalties on the net commercial sales of TLANDO within the agreed territory.

Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine, expressed enthusiasm regarding the collaboration with SPC Korea, stating that it represents a strategic move to expand TLANDO’s global reach and address unmet medical needs in South Korea. He underlined the significance of the license agreement in advancing Lipocine’s goals to provide innovative therapies to patients and create value for shareholders.

TLANDO, an FDA-approved testosterone replacement therapy for adult males, is designed to address conditions associated with a deficiency or absence of endogenous testosterone. Developed using Lipocine’s proprietary Lip’ral drug delivery technology platform, TLANDO has shown promise in treating primary hypogonadism and hypogonadotropic hypogonadism.

For additional information on Lipocine and its product portfolio, interested parties can visit www.lipocine.com. The company continues to explore a range of drug candidates and strategic partnerships to advance its mission of delivering differentiated therapies through effective oral delivery methods.

Disclaimer: This article contains forward-looking statements made in accordance with the Private Securities Litigation Reform Act of 1995. Investors are advised that these statements involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

Source: Lipocine Inc.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Lipocine’s 8K filing here.

About Lipocine

Lipocine Inc, a clinical-stage biopharmaceutical company, engages in the research and development for the delivery of drugs for the treatment of central nervous system (CNS) disorders. Its lead product candidate is TLANDO, an oral testosterone replacement therapy (TRT) comprising testosterone undecanoate.