Full Press Release Details
LIPOCINE COMPLETES POST ACTION MEETING
WITH FDA FOR THE LPCN 1021 NEW DRUG APPLICATION
SALT LAKE CITY (OCTOBER 17, 2016) -
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced the completion of a Post Action meeting
with the U.S. Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN
1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions
associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was
to review the Complete Response Letter ("CRL") and to determine actions needed to achieve approval of LPCN 1021.
The CRL, issued June 28, 2016, identified deficiencies related
to the dosing algorithm for the label. In response to the CRL, Lipocine proposed a dosing regimen based on analyses of existing
data. The FDA noted that while Lipocine's proposed dosing regimen might be acceptable, validation in a clinical trial
would be needed prior to resubmission. As a result, Lipocine has submitted the new dosing validation clinical study protocol to
the FDA and the FDA has agreed to review the protocol through a Special Protocol Assessment ("SPA"). An SPA
is an advanced declaration from the FDA that a planned trial's design, clinical endpoints, and statistical analyses could potentially
result in data acceptable for FDA review towards approval for the proposed indication.
"We were pleased to have had a very productive meeting
with the FDA with a path identified to bring our NDA for LPCN 1021 into a position for approval," said Dr. Mahesh Patel, Chairman,
President and CEO of Lipocine. "We remain committed to bring LPCN 1021 to the market."
LPCN 1021 is a novel twice-a-day oral testosterone replacement
therapy product candidate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN
1021 will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting
injectable products as well as topical products that carry an FDA "black box" warning related to inadvertent transfer
of testosterone to others. According to the IMS Health database, an average of half a million prescriptions a month have been dispensed
so far in 2016 for TRT.
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 LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily
oral testosterone replacement therapy product candidate, was well tolerated and met the primary efficacy end point in Phase 3 testing,
which utilized 24-hour pharmacokinetic data for dose adjustments. LPCN 1111, a novel prodrug of testosterone, originated with 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, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention
of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA was recently
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 FDA review process relating to LPCN 1021, the additional clinical trial
needed to validate our dosing regimen and the FDA process with respect to our planned SPA, the possible outcome and timing of such
clinical trial or FDA review process, the path to approvability by the FDA of LPCN 1021, our commitment to bring LPCN 1021 to market,
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 LPCN 1021 or any of our other products, risks related to our products, expected product benefits, clinical and regulatory
expectations and plans, regulatory developments and requirements, risks related to the receipt of a CRL from the FDA for LPCN 1021,
the receipt of regulatory approvals, the results and timing of clinical trials, including the additional clinical trial for LPCN
1021, 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 Officer
Phone: (801) 994-7383
Phone: (443) 213-0506