SALT LAKE CITY, Nov. 12, 2015 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the quarter ended September 30, 2015, as well as recent operational highlights.
Quarterly and Recent Highlights
• Submitted a 505(b)(2) New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (“hypogonadism”). The filing is supported by results from Lipocine’s Study of Oral Androgen Replacement (“SOAR”) pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021 in hypogonadal men with low testosterone.
• Announced first subject dosed in its multi-dose PK dose finding clinical study for LPCN 1107, the company’s oral hydroxyprogesterone caproate (“HPC”) product candidate, being developed as a potential therapy for the prevention of pre-term birth (“PTB”). The primary objective of the study will be to study pharmacokinetics over an extended period of time with multiple dose strengths of oral administration of LPCN 1107 in pregnant women.
• Announced the acceptance of the NDA for LPCN 1021 by the FDA. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”) action date of June 28, 2016, for completion of the review of the NDA for LPCN 1021.
Additionally the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021.
“The highlight of the quarter was the filing of our NDA for LPCN 1021, a significant milestone for the company. We remain focused on bringing this oral testosterone replacement product candidate to patients, which we believe has the potential both to improve the ease of use compared to the available formulations, including topical gels and injections, and to overcome inadvertent testosterone transference risk to children and partners,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “In addition, we made significant progress on the development of LPCN 1107, one of our novel pipeline products.”
Third Quarter 2015 Financial Results
Lipocine reported a net loss of $6.4 million, or $0.35 per diluted share, for the third quarter of 2015, compared with a net loss of $4.1 million, or $0.32 per diluted share, for the third quarter of 2014.
For the third quarter of 2015, research and development expenses were $4.7 million, compared with $3.2 million for the third quarter of 2014. The increase was largely attributable to a one-time payment of $2.3 million to the FDA for the NDA filing, partially offset by decreased clinical research, consultant and manufacturing costs related as Phase 3 study for LPCN 1021 was completed.
For the third quarter of 2015, general and administrative expenses were $1.7 million, compared with $872,000 for the same period in 2014. The increase was primarily due to increased personnel costs and costs related to market research and pre-commercialization activities.
As of September 30, 2015, Lipocine had cash, cash equivalents, and marketable investment securities of $47.8 million, compared with cash and cash equivalents of $27.7 million as of December 31, 2014.
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. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA.
Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.
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