FDA Confirms Lipocine's Previously-Agreed Clinical Development Plan for LPCN 1021

Lipocine Inc.

, a specialty pharmaceutical company, today announced that it has received confirmation from the U.S. Food and Drug Administration ("FDA") that the design of its ongoing pivotal Study of Oral Androgen Replacement ("SOAR") Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021 in hypogonadal men with low testosterone ("Low T") is currently acceptable for filing a New Drug Application ("NDA") for the class testosterone replacement therapy ("TRT") labeling. The FDA reiterated the primary efficacy endpoint required for approval being 75% of subjects with a Cavg for serum testosterone in the normal range with the lower bound of the two-sided 95% confidence interval being >65%. Lipocine remains confident that our efficacy results are in line with approval requirements. The FDA did not identify any additional clinical studies that would be required for NDA filing, but did state that should any safety signal become apparent during analysis of our SOAR Phase 3 study results or during the course of their review, it is possible that additional data may be required. Based on the response received, Lipocine does not anticipate the need to conduct additional studies above those previously agreed to with the FDA for NDA filing. The FDA also acknowledged that they are still internally discussing the advice and recommendations from the FDA Advisory Committee held on September 17, 2014. "We are pleased that the FDA confirmed that our SOAR Phase 3 clinical study design is sufficient for filing our NDA with LPCN 1021 for the class TRT labeling. We continue to target the second half of 2015 for filing the NDA upon completion of the ongoing safety extension," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. Dr. Patel further stated, "We continue to believe that LPCN 1021 represents a 'best-in-class' TRT option with the potential to both improve patient compliance and overcome inadvertent testosterone transference risk."