Full Press Release Details
FDA Advisory Committee Scheduled to Review
TLANDO on January 10, 2018
SALT LAKE CITY, UT, October 18, 2017
- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration
("FDA") has scheduled the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") meeting on
January 10, 2018 to discuss the New Drug Application ("NDA") for TLANDO , the Company's 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 FDA has previously set February 8, 2018 as the Prescription
Drug User Fee Act ("PDUFA") goal date.
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. Although the FDA will consider
the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations
by the panel are non-binding.
Lipocine announced on August 14, 2017 that the FDA had acknowledged
receipt of the NDA resubmission for TLANDO. The NDA included the results of a Dosing Validation ("DV") study which
confirmed the efficacy of TLANDO with a fixed dose regimen without need for dose adjustment, together with an integrated safety
set ("ISS") from all conducted clinical trials of TLANDO.
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
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 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
Phone: (801) 994-7383
Phone: (646) 597-6979