Shares of specialty pharmaceutical name Lipocine (LPCN 1.96, -1.50 -43.4%) have lost nearly half their value and are making all-time lows today in reaction to last night’s decision by the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug Administration that voted six in favor and thirteen against the benefit/risk profile of TLANDO, the company's oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
We’d highlight that the AdComm decision is not definitive and by no means is an indication of the final FDA vote, which is scheduled for a Prescription Drug User Fee Act (PDUFA) date of May 8, 2018. The role of BRUDAC is to provide recommendations to the FDA.
As mentioned, last night after the close the FDA panel voted 6-13 on the question posed: Is the overall benefit/risk profile of Tlando acceptable to support approval as a testosterone replacement therapy?
On the whole, LPCN’s data held that Tlando (LPCN 1021) successfully met the FDA primary efficacy guidelines in the DV study where 81% of the subjects achieved average testosterone levels within the normal range with a lower bound confidence interval ("CI") of 72%.
This data was announced in June of 2017, and along with meeting both primary and secondary endpoints, LPCN’s 1021 experienced adverse events in both the DV and DF studies which were consistent with the previously conducted 52-week Phase 3 Study of Androgen Replacement clinical trial. All drug related adverse events were either mild or moderate in intensity and none were severe.
Specifically, AE's occurring in more than 5% of subjects with either treatment were upper respiratory tract infection (5.2% with TLANDO and 5.8% with active control) and fatigue (2.4% with TLANDO and 6.7% with active control). Additionally, all Adverse Drug Reactions, drug-related AEs, occurring in more than 2% of subjects with either treatment were headache (0.5% with LPCN 1021 and 3.9% with active control), acne (2.9% with TLANDO and 2.9% with active control) and patient reported weight increase (2.4% with TLANDO and 0% with active control). Weight changes greater than 10% from baseline over 52 weeks occurred in 2.3% of subjects with TLANDO and 3.8% of subjects with active control.
Still, Adcomm members expressed apprehension regarding the safety profile of LPCN 1021. With about $9.3 million in cash on hand and cash equivalents and total assets around $26.1 million, time may be running out on Tlando.
Next up, the May 8, 2018 PDUFA date.