SALT LAKE CITY, Dec. 05, 2016 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced it plans to
initiate a dosing validation study after receiving feedback from the U.S. Food and Drug Administration (“FDA”) of its protocol for
LPCN 1021. LPCN 1021 is an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for
conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
Based on the assessment received, Lipocine plans to initiate the dosing validation (“DV”) study immediately and expects that the
first patient will be screened in December 2016. The results of the DV study are expected to validate the dosing regimen for
LPCN 1021 and provide critical data required for resubmission. The DV study is an open-label, fixed dose, single treatment
arm study of LPCN 1021 in hypogonadal males and is expected to enroll 100 subjects. Efficacy will be assessed via responder
analysis at the end of the dosing period which is 24 days. The pre-specified primary endpoint is the percentage of subjects
with an average 24-hour serum testosterone concentration (“Cavg”) within the normal range, with secondary endpoints based on
maximum serum testosterone concentrations (“Cmax”).
"We are pleased with the clarity received from the FDA on the DV study protocol, especially as we continue to advance LPCN 1021
into a position for approval,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. “We look forward to the DV study
initiation with top-line results from the DV study anticipated in the second quarter of 2017."
About LPCN 1021
LPCN 1021 is a novel twice-a-day oral Testosterone Replacement Therapy product candidate containing Testosterone Undecanoate
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. Per the
IMS Health database, an average of 540,000 prescriptions a month have been dispensed so far in 2016 for testosterone products.
About Lipocine
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 results of the Phase 2b clinical study of LPCN 1111, 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.
CONTACT: Morgan Brown Executive Vice President & Chief Financial Officer Phone: (801) 994-7383 mb@lipocine.com Investors: John Woolford Phone: (443) 213-0506 john.woolford@westwicke.com
![Primary Logo](https://resource.globenewswire.com/Resource/Download/e3bb38a9-232c-4cb9-bc0b-e6f4bb3ab858?size=1)
![](http://www.globenewswire.com/newsroom/ti?ndecode=MTg0IzY2NTAyOTM=)