SALT LAKE CITY, Jan. 14, 2019 /PRNewswire/ -- 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 judgment ordered by the PTAB which validates
the strength of Lipocine's patent portfolio," said Dr. Mahesh Patel, Chairman, President and CEO of
Lipocine.
About Lipocine
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 by
law.
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SOURCE Lipocine Inc.