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LPCN: Files NDA for LPCN 1021 with FDA Approval on Track for 2016…


Lipocine Inc. (LPCN) is a specialty pharmaceutical company that has an oral drug delivery technology system, Lip’ral™, for products that affect the health of men and women. The Lip’ral™ promicellar technology is a patented platform based on lipid compositions which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs. The company is currently developing three product candidates in conjunction with this system (LPCN 1021, LPCN 1111, and LPCN 1107) that are designed to enhance the pharmacokinetic parameters of the drugs, facilitate lower dosing requirements, reduce side effects, and limit gastrointestinal interactions that would otherwise decrease the effectiveness of the compounds.

Business Update

We continue to remain optimistic regarding the Lipocine story. For the purpose of this research report, we would like to offer a quick update regarding LPCN 1107 and LPCN 1111 in addition to shedding some light on the Repros Therapeutics’ enclomiphene citrate story in regards to LPCN 1021, and how this should be viewed by Lipocine investors.

Lipocine is developing LPCN 1107 as the first oral hydroxyprogesterone caproate (HPC) for the potential treatment of prevention of preterm birth (PTB) by formulating HPC with the Lip’ral™ technology. An oral formulation of HPC would offer a number of advantages over the current injectable formulation of the drug, including elimination of pain and reaction at the injection site as well as eliminating weekly trips to the doctor’s office for administration of the compound. In approximately 12% of pregnancies, babies are born prior to 37 weeks gestation, which is the definition of preterm birth. Preterm birth is associated with a wide range of problems, including breathing issues, feeding difficulties, cerebral palsy, developmental delay, vision problems, and hearing impairment. In addition, preterm birth remains the leading cause of infant mortality, accounting for as many as 75% of perinatal deaths (Ananth et al., 2006).

On September 28, 2015, Lipocine announced initiation of its Phase 2 multi-dose PK dose finding clinical study with the first subject dosed with LPCN 1107. The primary objective of the study will be study pharmacokinetics over an extended period of time in pregnant women at multiple dose strengths of oral administration of LPCN 1107. With two Phase 1 proof-of-concept studies in both pregnant and non-pregnant women completed, we believed that this dose selection Phase 2 study would commence in the fourth quarter 2015 or first quarter 2016, so we are happy to report that the first patient has been dosed earlier than we expected during the third quarter 2015. We believe that top-line results will be reported during the first quarter 2016. Once this study is completed, Lipocine plans to schedule an End-of-Phase 2 meeting with the FDA regarding the Phase 3 development plan. We think this meeting will occur at some point during the second quarter 2016. If all goes well, we believe that LPCN 1107 will be Phase 3 ready by mid-late 2016. We continue to believe that the area of preterm birth, even in countries as developed as the United States, is an area of unmet need, and at this point, we see a path forward for LPCN 1107 and look forward to watching the LPCN 1107 story unfold.

As a reminder, LPCN 1107 received orphan drug designation in June 2015 by the FDA and has the potential to become the first oral HPC product for the prevention of pre-term birth in women with a prior history of at least one pre-term birth. In order to obtain orphan drug exclusivity upon approval, we would like to mention that LPCN 1107 will need to demonstrate clinical superiority to the same drug already approved for the same orphan indication. This can be achieved, for instance, by demonstrating clinical superiority through establishing that the product offers a "major contribution to patient care."

LPCN 1111, is the next-generation oral TRT version of LPCN 1021, that has the potential for once daily dosing through the Lip’ral™ technology. With positive Phase 2a data in place, a Phase 2b trial is expected to begin in the fourth quarter of 2015, and an End-of-Phase 2 meeting with the FDA should occur at some point during the second quarter 2016. We believe that it should be Phase 3 ready by mid-2016. As per management guidance, LPCN 1111 is about 24 months behind LPCN 1021. In our view, based on Phase 2a data, this drug looks like a potential game-changer for TRT.

    On August 28, 2015, Lipocine Inc. submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Lipocine’s lead asset LPCN 1021. LPCN 1021 is a testosterone replacement therapy (TRT) designed for oral twice daily dosing in adult hypogonadal males with low testosterone. We should find out the status of the application in November 2015, and if it is indeed accepted, we expect a PDUFA date will be set for some time in June 2016, following the standard 10-month review period. Lipocine has continually executed on the timeline previously laid out for developing LPCN 1021, and we are happy to report that the company filed the NDA with the FDA as per prior guidance.

Results from the Phase 3 Study of Oral Androgen Replacement ("SOAR") trial was part of the NDA submission...