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Lipocine Inc. (LPCN) Announces Successful Phase 1 Results With LPCN 1107, Potentially The First Oral Product For The Prevention Of Preterm Birth



5/15/2014 9:44:07 AM

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SALT LAKE CITY, May 15, 2014 (GLOBE NEWSWIRE) -- Lipocine Inc. (Nasdaq:LPCN), a specialty pharmaceutical company, today announced the successful completion of a Phase 1 study of LPCN 1107, the company's oral hydroxyprogesterone caproate (HPC) product candidate. The study was designed to determine the pharmacokinetics and bioavailability of LPCN 1107 relative to an intramuscular (IM) HPC, as well as safety and tolerability, in healthy non-pregnant female volunteers.

"We are pleased with the results of this study, as it confirms our pre-clinical data by achieving meaningful drug levels after oral administration of this highly insoluble drug," said Dr. Mahesh Patel, President, CEO and Chairman of Lipocine Inc. "To our knowledge no significant oral bioavailablity has ever been reported for this established drug. Hydroxyprogesterone caproate is the only drug approved for prevention of recurrent preterm birth, a leading cause of peri-natal mortality and morbidity worldwide, but it is currently only available in an inconvenient injectable form. We believe that an oral alternative will be a major contribution to patient care and we are encouraged that LPCN 1107 has the potential to become the first oral product for prevention of preterm birth."

Based on this steady state simulation, LPCN 1107 could match the HPC exposure from the weekly IM injection at an appropriate oral dose.

Based on these results, a study is planned to assess the pharmacokinetics and bioavailability of LPCN 1107 relative to IM in pregnant females to begin in the second half of 2014.

LPCN 1107 was well tolerated and the only significant treatment related adverse events observed was abnormal menstrual effects in both the LPCN 1107 and IM arms in some subjects which is not an unexpected progestogenic effect in non-pregnant females of child-bearing age.

About LPCN 1107

LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits. LPCN 1107 has completed PK studies in dogs showing oral exposure comparable to an intramuscular injection.

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 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 expectations, clinical trials, 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.

CONTACT: Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com

John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com

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