Full Press Release Details
Lipocine Announces Update on Jury Trial
in Patent Infringement Lawsuit Against Clarus Therapeutics
LAKE CITY, December 29, 2020 -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced that Judge William C. Bryson of the United States District Court of Delaware
has postponed the February 8, 2021 jury trial scheduled to hear arguments in the patent litigation case of Lipocine Inc. vs.
Clarus Therapeutics Inc. due to the ongoing effects of the COVID-19 pandemic. The jury
trial will be rescheduled once it becomes clear when jury trials will resume in the District of Delaware.
In the pending suit against Clarus Therapeutics, Inc. ("Clarus")
Lipocine is alleging that Clarus's JATENZO product infringes Lipocine's U.S. patents: 9,034,858; 9,205,057; 9,480,690;
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's
clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a novel oral prodrug of
testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with
a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1144, an oral product of bioidentical
testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility in the treatment of non-cirrhotic
NASH. LPCN 1144 is currently being studied in a Phase 2 clinical study. TLANDO XR, a novel oral prodrug of testosterone,
originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing.
In a phase 2 clinical evaluation when administered as once daily or twice daily TLANDO XR met the typical primary and secondary
end points. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. LPCN 1107 is potentially
the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has
been granted orphan drug designation by the FDA. For more information. For more information, please visit www.lipocine.com.
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 Lipocine's product candidates and related clinical trials, the timing of completion of
clinical trials, including the LIFT clinical study, the potential uses and benefits of our product candidates, our product
development efforts, and timing of ongoing litigation. Investors are cautioned that all such forward-looking statements involve
risks and uncertainties, including, without limitation, the risks that 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,
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
For further information:
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743