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Lipocine Announces FDA Advisory Committee Meeting for

Key Takeaway: Lipocine Announces FDA Advisory Committee SALT LAKE CITY, UT, September 20, 2017 - Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administr

Full Press Release Details

Lipocine Announces FDA Advisory Committee
SALT LAKE CITY, UT, September 20, 2017
- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic
Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") plans to discuss the
New Drug Application ("NDA") submitted by the Company for TLANDO, its oral testosterone product candidate for the proposed
indication of testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of
endogenous testosterone, also known as hypogonadism. The advisory committee meeting date has not been finalized but will occur
prior to the Prescription Drug User Fee Act ("PDUFA") goal date of February 8, 2018.
"We believe TLANDO addresses a significant
unmet medical need for men with hypogonadism," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.
"With TLANDO's robust primary endpoint results, comparable safety profile to the active control, flexibility in dietary
fat consumption, and no requirement for dose titration, we remain confident in our ability to potentially bring the first oral
TRT option to patients and look forward to discussing our NDA with BRUDAC."
BRUDAC reviews and evaluates data on the safety
and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology and related specialties,
and makes appropriate recommendations to the Commissioner of the FDA.
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 three development programs TLANDO, 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 was well tolerated and met the primary efficacy end-points in Phase 3 testing with twice daily dosing and is currently
under FDA review. 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
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 product candidates and related clinical trials
and the FDA review process relating to its product candidates, the expected timing of the FDA review process related to our resubmitted
NDA, 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, the risks that the FDA will not approve any of our products, the risk that BRUDAC
may make a negative recommendation to the Commissioner of the FDA with respect to TLANDO, 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 that the FDA will determine there are deficiencies in our
resubmitted NDA, 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.
Executive Vice President & Chief Financial
Phone: (801) 994-7383
Phone: (646) 597-6979
Last updated: Sep 20, 2017