Full Press Release Details
USPTO GRANTS PRIORITY MOTION TO LIPOCINE
AND ENTERS JUDGMENT AGAINST CLARUS
SALT LAKE CITY (January 14, 2019) - Lipocine
Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Patent Trial and Appeal Board ("PTAB")
of the United States Patent and Trademark Office ("USPTO") granted Lipocine's Priority Motion in the interference
case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. ("Clarus") U.S. Patent No. 8,828,428 (the
"Clarus 428 Patent") and Lipocine Inc. ("Lipocine"), U.S. Patent Application No. 14/713,692 (the
"Lipocine 692 Application"), and entered adverse judgment against Clarus. The PTAB ruling cancels all claims
of the Clarus 428 patent.
"We are pleased with the judgement ordered by the PTAB
which validates the strength of Lipocine's patent portfolio," said Dr. Mahesh Patel, Chairman, President and CEO of
Lipocine Inc. is a specialty pharmaceutical
company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies.
Lipocine's clinical development pipeline includes four development programs TLANDO, LPCN 1144, LPCN 1111 and LPCN 1107. TLANDO,
a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels
in hypogonadal men. TLANDO received a Complete Response Letter from the FDA on May 8, 2018. LPCN 1144, an oral prodrug of bioidentical
testosterone, is being developed as a treatment of non-alcoholic steatohepatitis ("NASH") and is currently being studied
in a proof-of-concept MRI PDFF based liver fat imaging clinical study. LPCN 1111, 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 and is currently
in Phase 2 testing. 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. An End of Phase 2 meeting with the FDA has
been completed. 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 Lipocine's options to enforce
and defend our intellectual property, Lipocine's product candidates and related clinical trials and the FDA review process
relating to its product candidates, the timing of completion of clinical trials including the definitive phlebotomy study
and the ABPM study for TLANDO as well as ongoing LPCN 1144 clinical trials, the path to approvability by the FDA of Lipocine's
development programs, the potential uses and benefits of our product candidates, and our product development efforts. Investors
are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, risks
related to our ability to enforce and defend our intellectual property, 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
Executive Vice President & Chief Financial
Phone: (801) 994-7383
Phone: (646) 597-6979