SALT
LAKE CITY, Oct. 8, 2024 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a biopharmaceutical company leveraging its
proprietary technology platform to augment therapeutics through
effective oral delivery, today announced an exclusive supply and
distribution agreement with Pharmalink https://pharmalink.ae/ to
commercialize TLANDO®, its oral testosterone replacement therapy,
in the Gulf Cooperation Council (GCC) countries consisting of
Saudi Arabia, Kuwait, the United
Arab Emirates (UAE), Qatar,
Bahrain, and Oman.
Under the terms of the agreement, Lipocine received an upfront
payment from Pharmalink and, upon Marketing Authorizations (MA) in
individual GCC countries, Lipocine will provide TLANDO drug product
to Pharmalink at an agreed transfer price. Pharmalink will have the
exclusive rights to TLANDO throughout the GCC region and will be
responsible for promotion, distribution and sale of the product in
the territory.
"We are very pleased to partner with Pharmalink to bring TLANDO
to the GCC region," said Dr. Mahesh
Patel, President and CEO of Lipocine Inc. "This agreement is
aligned with our global strategy to expand the availability of
TLANDO and make it broadly accessible. Pharmalink's expertise
and established network in GCC make them an ideal partner to
support the adoption and growth of TLANDO in the region."
About TLANDO
TLANDO is approved in the United
States by the U.S. 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). TLANDO 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, comprised of an oral proprietary
anabolic androgen receptor agonist, 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.