SALT
LAKE CITY, Oct. 31, 2024 /PRNewswire/ -- Lipocine
Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery, today announced a license, development and
supply agreement with to SPC Korea http://spcpharm.co.kr granting
exclusive rights to market TLANDO® in South Korea.
Under the terms of the distribution and license agreement,
Lipocine will receive an upfront payment and is also eligible to
receive certain regulatory and sales milestone payments, including
a payment upon regulatory approval of TLANDO in South Korea. Lipocine is entitled to royalties
on net commercial sales. Lipocine will supply TLANDO to SPC Korea
and will receive a supply price. SPC Korea will assume
responsibility for obtaining regulatory approval within the
territory.
"We are very pleased to partner TLANDO with SPC Korea," said
Dr. Mahesh Patel, President and Chief Executive Officer of
Lipocine. "This license agreement represents a strategic
opportunity to expand the global reach of TLANDO and to
address the significant unmet medical need in South Korea. It underscores Lipocine's
commitment to strategic partnerships that have the potential to
drive growth and create value for our shareholders while advancing
our goals to deliver innovative therapies to patients."
About TLANDO
TLANDO is approved by the US 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 full prescribing information, please
visit www.TLANDO.com.
About Lipocine
Lipocine is a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery to develop differentiated
products. Lipocine has drug candidates in development as well
as drug candidates for which we are exploring partnerships. 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.
Lipocine's clinical development candidates include: LPCN 1154,
oral brexanolone, for the potential treatment of postpartum
depression, LPCN 2101 for the potential treatment of epilepsy, LPCN
2203 an oral candidate targeted for the management of essential
tremor, LPCN 2401 an oral proprietary combination of anabolic
androgen receptor agonist and α-tocopherol, an antioxidant, as an
adjunct therapy to incretin mimetics, as an aid for improved body
composition in chronic weight management 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, LPCN
1154, for rapid relief of postpartum depression, LPCN 2401 for
chronic weight management, 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.
Forward-Looking Statements
This 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 our product development efforts, our
strategic plans for developing products, our ability to monetize
product candidates, including through entering into partnering
arrangements, our product candidates and related clinical trials,
the achievement of milestones within and completion of clinical
trials, the timing and completion of regulatory reviews, outcomes
of clinical trials of our product candidates, 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, 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.
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SOURCE Lipocine Inc.
