Lipocine Announces Results From Pre-NDA Meeting for LPCN 1021, an Oral Testosterone Product Candidate

Lipocine Inc.

, a specialty pharmaceutical company, today announced that it has completed its pre-New Drug Application ("NDA") meeting with the U.S. Food and Drug Administration ("FDA") related to LPCN 1021, its Oral Testosterone product for hypogonadal men with low testosterone. The purpose of the meeting was to discuss and obtain concurrence regarding adequacy for submission of the proposed NDA package for LPCN 1021 and to receive guidance on the 505(b) (2) filing and approval. Based on the FDA's preliminary response, Lipocine does not expect to conduct any additional clinical studies other than the on-going labeling "food effect" study which has always been required for the expected submission of the NDA. Lipocine is conducting the labeling "food effect" study per the FDA requirement and plans to submit preliminary results from this study to the FDA in the second quarter of 2015 for review and comment prior to submitting the NDA. The labeling "food effect" study is an open-label, randomized, four period, four treatment, crossover, single dose study evaluating bioavailability and pharmacokinetics of LPCN 1021 as a function of food fat content in hypogonadal males. The study is being conducted at a single site and will enroll 16 hypogonadal males with ages ranging between 18 and 80. Based on our meeting with the FDA, we do not expect to be required to conduct a heart attack and stroke risk study or any additional safety studies prior to filing the NDA for LPCN 1021. As a result of our meeting, there is no change in our previous guidance with respect to our projected NDA filing for LPCN 1021 in the second half of 2015. "We are pleased with a very productive pre-NDA meeting with the FDA that enabled us to get detailed guidance regarding our planned NDA filing. This meeting represents the completion of another important milestone for Lipocine. LPCN 1021 has the potential to be the 'best-in-class' testosterone replacement option, with respect to both improved patient compliance and elimination of the inadvertent testosterone transference risk," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. Dr. Patel further stated, "We look forward to the announcement of the one-year safety data from the pivotal Phase 3 study by mid-year as well as the NDA filing in the second half of this year." LPCN has previously announced positive efficacy and safety results 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. The study demonstrated positive results with respect to the trial's primary efficacy endpoint with no serious adverse events to date classified as drug related or cardiovascular in nature.