Lipocine Inc. (NASDAQ: LPCN) stock declined by 1.55% at last close whereas the LPCN stock price plunged by 2.36% in the pre-market trading session. Lipocine is a clinical-stage biopharmaceutical business that uses its patented drug delivery technology to treat metabolic and endocrine diseases.
What is happening?
Clarus and Lipocine reached a settlement for all remaining claims in Lipocine’s patent infringement litigation against Clarus, as well as a patent interference dispute between the two companies. Lipocine filed a patent infringement lawsuit against Clarus in response to Clarus’s marketing of JATENZO, an oral testosterone replacement therapy. A Clarus patent application was awaiting issue by the USPTO at the time of the interference action.
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Clarus’ motion for summary judgment of invalidity of all of Lipocine’s alleged patent claims in the action was granted on May 25, 2021. Lipocine and Clarus have decided to terminate the Lipocine Inc. v. Clarus Therapeutics, Inc., Civil Action No. 19-cv-622 lawsuit now ongoing in the United States District Court for the District of Delaware, as part of the settlement reported today. Moreover, both parties have entered into an agreement on the interference, which is now pending at the USPTO and is titled Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128. The specifics of the settlement aren’t public, but they don’t include any money from Clarus to Lipocine.
Lipocine has reported that the U.S. The Food and Drug Administration has given LPCN approval to begin a Phase 2 trial to assess the therapeutic effects of LPCN 1154, an oral neuro-steroid product candidate, for the therapy of postpartum depression in adults.
In July 2021, a pharmacokinetic study to determine dosage proportionality will begin, with top-line results anticipated in the third quarter of 2021. A proof-of-concept trial to investigate the safety, acceptability, and effectiveness of LPCN 1154 in adult female patients diagnosed with PPD is planned to begin in the fourth quarter of 2021, after the PK study.