Full Press Release Details
LIPOCINE ANNOUNCES PRESENTATION OF LPCN 1021 CLINICAL DATA
SALT LAKE CITY (February 27, 2015)
- Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today announced
that data from its ongoing Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300)
evaluating efficacy and safety of LPCN 1021, an Oral Testosterone product, in hypogonadal men with low testosterone ("Low
T") will be presented at ENDO 2015 in San Diego, CA. As previously announced, overall, the study demonstrated positive results
with respect to the trial's primary efficacy endpoint with no drug related serious adverse events to date.
Presentation details are as follows:
| Session: | Testosterone Replacement Therapy: Risks and Benefits |
| Title: | Efficacy and Pharmacokinetics of LPCN 1021, a Novel Oral Testosterone Replacement Therapy (TRT) in Hypogonadal Men: Study of Androgen Replacement (SOAR) |
| Date/Time: | Saturday, March 7, 2015, 11:30 am - 1:00 pm PT |
| Oral Session Number: | OR34-5 |
| Presenter: | Christina Wang, MD |
| Associate Director | |
| UCLA Clinical and Translational Science Institute | |
| Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute | |
| Professor of Medicine | |
| David Geffen School of Medicine at UCLA |
The current testosterone market is dominated by topical products
that are associated with poor patient compliance and FDA "black box" warnings related to inadvertent transfer of testosterone.
LPCN 1021 is a twice-a-day, oral product candidate with three simple oral dosing options that we expect will overcome the major
shortcomings of existing products.
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 lead product candidate, LPCN 1021, demonstrated positive top-line efficacy results in Phase 3 testing and is targeted
for testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy
product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first
oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth, and is currently in Phase 1
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 relating to expectations regarding clinical trials, the potential uses and benefits of Lipocine's
product candidates, and product development and commercialization efforts. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product
benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, the receipt of regulatory approvals,
the results 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 U.S. Securities and Exchange Commission (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 Company's
website at www.lipocine.com or 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 Officer
Phone: (801) 994-7383
Email: mb@lipocine.com
Phone: (443) 213-0500