Full Press Release Details
Lipocine Announces Trial Date in Lipocine's
Infringement Lawsuit against Clarus
Therapeutics and Will Seek a Permanent Injunction
SALT LAKE CITY, UT, August 27, 2019
- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine
disorders, announced today that the U.S. District Court of Delaware has set a trial date for Lipocine's patent infringement
lawsuit against Clarus's JATENZO drug product relating
to six of Lipocine's U.S. patents. Trial is set to begin August 24, 2020 at which time Lipocine plans to seek a permanent
injunction for Clarus's infringement.
"Lipocine has full confidence
in its intellectual property and will continue to vigorously assert its infringement claims against Clarus," said Dr. Mahesh
Patel, Chairman, President, and Chief Executive Officer of Lipocine.
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 four development programs TLANDO, LPCN 1144, TLANDO XR (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.
LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the
potential utility the in treatment of NASH. TLANDO XR (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
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, the timing, completion and activities around current litigation,
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, 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
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (646) 597-6979