Lipocine Inc (NASDAQ:LPCN) has announced that the US District Court of Delaware, has accepted the company’s motion and dismissed the lawsuit, filed by Clarus Therapeutics Inc. The company had been accused by Clarus, for patent infringement, in LPCN1021, an oral testosterone product. Dr. Mahesh Patel, the CEO of Lipocine, expressed his pleasure at the court’s decision and announced that they would continue to defend their IPs in the future. He further reaffirmed his belief in the ability of LPCN1021 in improving the ease of use, as compared to other forms of treatment.
However, the dismissal of the lawsuit was not the only reason for the stock’s most recent rally. Earlier, LPCN had announced top of the line results, from a phase2b clinical trial of LPCN1111. It should be noted here that this drug is also developed for oral testosterone replacement therapy. Lipocine noted that it had successfully identified the right dosage for the phase 3 clinical trials, after having observed the tolerance levels of the drug. The management plans to meet with the FDA in 4Q2016, which would lead to the start of the phase 3 trials.
The company noted that the phase 2b trials were conducted for a total of 14-days and successfully met the primary and secondary end-points of the study. Moreover, LPCN had earlier conducted a study, the first in class oral drug, which required a 52-week extension. The company believes that this would not be the case this time and the phase 3 clinical trials would substantially cost less than its predecessor.
Analysts continue to believe that LPCN1021 would continue to be the largest valuation driver for the company, which has been resubmitted to the FDA. However, the NDA for the drug could possibly take over a year for approval, given that several new requirements can be stemmed out from the original application. As such, it is believed that LPCN1021 could be commercialized around the 4Q2017. It should be noted here that this estimate is dependent upon the outcome of the company’s meeting with the FDA.
Lipocine Inc (NASDAQ:LPCN) closed at a share price of $5.41, after having gained 29.74% in terms of share value, on a trade volume of 11.45 million, during the October 7 trading session.
