Full Press Release Details
and Verity Pharma Enter into License Agreement
TLANDO Franchise in the U.S. and Canada
| Lipocine to receive $11 million license fee | ||
| Up to $259 million in development and commercial sales milestones | ||
| Tiered royalties on net sales of licensed products up to 18% | ||
| Commercialization of TLANDO transitions to Verity Pharma effective Feb.1 2024 | ||
| Lipocine retains all rights for territories outside the United States and Canada, and all non-TRT rights globally |
LAKE CITY, January 18, 2024 - 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.
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.
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 without interruption in patient access to TLANDO,"
said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This transaction will further enable Lipocine's
strategy to focus on developing treatments for CNS disorders and to add value to our non-core assets."
is a large and growing market with ~8M annual prescriptions in the U.S. and ~650,000 in Canada.
James acted as financial advisor to Lipocine on this transaction.
is approved by the FDA as a 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). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform. For more details,
including full prescribing information, refer to tlando.com.
XR (also known as LPCN 1111) is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (TT) which
uses Lipocine's proprietary delivery technology to enhance solubility and improve systemic absorption. Lipocine has successfully
completed a Phase 2b dose finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying
the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.
Pharma is a specialty pharmaceutical company focused on delivering meaningful solutions to healthcare professionals and their patients.
Pharma works with best-in-class global pharmaceutical manufacturing partners to ensure that product quality and availability is a constant
deliverable. The company is also committed to supporting programs, initiatives, and organizations that help improve health, expand research
opportunities and promote education within the healthcare community. Learn more at www.veritypharma.com.
is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery
to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which
we are exploring partnering. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable
benefit to risk profile which target large addressable markets with significant unmet medical needs.
clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101
for the potential treatment of epilepsy and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for
the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate
for prevention of preterm birth, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated
cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing
testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone,
also known as hypogonadism, in adult males. For more information, please visit www.lipocine.com.
release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not historical facts regarding Verity Pharma's development and
commercialization of TLANDO and TLANDO XR, the amount of the license fee, milestone payments, and royalty payments we will ultimately
receive, Verity Pharma's ability to grow the TLANDO franchise, our product development efforts, the application of our proprietary
platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of and filing
of a NDA with the FDA for LPCN 1148, and the potential uses and benefits of our product candidates. Investors are cautioned that all
such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful
in developing product candidates to treat CNS disorders, we may not have sufficient capital to complete the development processes for
our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets,
the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and
regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval
process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results
and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's
products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports
on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise
publicly any forward-looking statements contained in this release, except as required by law.
further information: