Full Press Release Details
Lipocine Announces Issuance of U.S. Patent for
LAKE CITY (July 15, 2014) - Lipocine Inc. (NASDAQ Capital Markets: LPCN), a specialty pharmaceutical company, today
announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent number
8,778,922, entitled "Steroidal Compositions." This patent relates to pharmaceutical compositions having testosterone
undecanoate. The patent is expected to provide protection through January 2029 for LPCN 1021.
"This addition to our intellectual
property portfolio, which we believe will be listed in the Food and Drug Administration Orange Book, has the potential to significantly
lengthen our exclusivity period for LPCN 1021," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look forward
to presenting top-line data from our pivotal phase 3 study, or SOAR trial, for LPCN 1021 in the third quarter of this year."
LPCN 1021 is a twice-a-day, oral product
with low gastro-intestinal drug exposure that we expect will overcome the major shortcomings of existing products with a more patient/
physician friendly label that includes three simple dosing options and faster time to maintenance dose in most patients, which
we expect will improve patient compliance. Unlike a selective estrogen receptor modulator ("SERM"), LPCN 1021 is not
designed to interact with estrogen receptors and is targeted to address an unmet oral option needed in the established testosterone
replacement market for chronic use.
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, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of
testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy
product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the
prevention of recurrent preterm birth.
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 includes statements that are not historical facts relating to the potential uses and benefits of Lipocine's product candidates
and product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties,
including, without limitation, the risks related to 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 Form 8-K, 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