Full Press Release Details
Denies Clarus's Oral Testosterone Ester Citizen Petition
SALT LAKE CITY, UT, April
17, 2020 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical
company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA")
denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019. Specifically, the FDA
declined to issue product-specific guidance on oral T-ester drug products and denied without comment Clarus' request regarding
how the FDA should review and make approval decisions on any pending or future oral T-ester products.
originally filed the Citizens Petition with the FDA requesting the FDA issue "clear, written guidance regarding the safety
and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy" and requested
the FDA not to approve "any pending [new drug application ("NDA")] for an oral T-ester to treat male hypogonadism
that fails to meet the standards for approval set forth in [the] petition."
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, is designed to help restore normal testosterone levels
in hypogonadal men. Lipocine has resubmitted its NDA to the FDA for TLANDO and has a PDUFA date of August 28, 2020. LPCN 1144,
an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential
utility in the treatment of pre-cirrhotic NASH. 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 NASH cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone
caproate product candidate, with end of phase 2 meeting completed, indicated for the prevention of recurrent preterm birth and
has been granted orphan drug designation by the FDA. 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 potential future actions and decisions
by the FDA. 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, risk related to on-going
litigation 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.
Executive Vice President &
Chief Financial Officer
Phone: (801) 994-7383
Phone: (617) 535-7743