Shares of Lipocine (LPCN) have risen roughly 12% yr to this point, however have misplaced half their worth since receiving a Full Response Letter in June 2016 from the FDA regarding their software for drug candidate TLANDO.
On August ninth, the corporate introduced it had resubmitted the NDA for LPCN 1021. Particularly, the earlier CRL had raised a problem relating to the dosing algorithm for the proposed label. The firm accomplished a dosing validation research, which served to verify the validity of a set dose method with the necessity for dose titration. Efficacy outcomes from the research together with security knowledge from prior research must be ample to deal with prior points raised by the FDA.
Towards the tip of September, the FDA announced an AdComm meeting the place the Bone, Reproductive and Urologic Medication Advisory Committee (BRUDAC) will talk about the New Drug Software for TLANDO for the proposed indication of testosterone alternative remedy in grownup males for situations related to a deficiency of endogenous testosterone (hypogonadism).
Whereas actual timing will not be identified, the assembly will happen earlier than the Prescription Drug Consumer Price Act (PDUFA) date of February eighth subsequent yr.
Determine 2: Market potential (supply: company presentation)
Additionally towards the tip of September, the corporate introduced a supposedly strengthened mental property place as a result of a positive ruling from the USPTO`s Patent Trial and Appeal Board.
For the second quarter, the small agency announced cash and equivalents of $27.eight million, whereas web loss for the quarter totaled $6.1 million. Analysis and improvement bills totaled $four.1 million with a lot of that associated to conducting the DV and the DF scientific research.
It must be famous that the corporate has a number of irons within the hearth. They submitted a Particular Protocol Evaluation request to the FDA to obtain suggestions on the design for his or her Part three program with LPCN 1107, which is being evaluated for the prevention of recurrent preterm delivery with historical past of singleton being pregnant. The major objective can be to ascertain non-inferiority with present commonplace of care Makena – as a degree of reference, second quarter sales of Makena grew 31% to over $102 million.
Additionally, the corporate initiated a preclinical toxicology research for LPCN 1111, a subsequent era oral testosterone alternative remedy with potential for once-daily dosing. After the research wraps up, administration plans to satisfy with the FDA for an Finish of Part 2 assembly. This may doubtless happen earlier than year-end.
Administration is kind of clear of their strategy- they plan to supply the primary out there oral choice for TRT ($2 billion market alternative), with prior scientific outcomes matching up properly in opposition to the present market chief. As TLANDO can be a set dose, no further physician visits can be required representing a major aggressive benefit. The prospect of avoiding gels and injections seems attractive.
The plan is then to comply with up TLANDO with LPCN 1111, which might maintain and probably develop revenues as a result of potential for QD dosing. Tailwinds within the TRT market would doubtless support adoption.
Lipocine is a Purchase.
Readers who’ve carried out their due diligence and have an interest within the story might provoke a pilot buy within the close to time period. So long as the inventory acts properly (staying within the $four vary or rising), think about including to the place for the PDUFA run up. Nonetheless, I’d counsel taking partial income previous to the regulatory assembly so as to handle danger.
The inventory has a small capitalization of lower than $100 million, that means that it may very well be susceptible to volatility and manipulation. Moreover, I think that within the close to to medium time period dilution is a risk as administration could wish to lengthen their operational runway contemplating the $27.eight million available and assets wanted for launch. Setbacks with the pivotal program for LPCN 1107 can be appeared upon unfavorably as properly, together with delays in initiation or enrollment.
Mental property considerations and litigation in regard to the present proceedings with Clarus Therapeutics additionally considerably add to danger right here. Whereas it seems that FDA approval might come this time, it’s on no account a certainty and partial income must be taken previous to their determination.
Competitors can be a major concern for longer-term traders right here – in June Clarus Therapeutics introduced completion of its Part three research for Jatenzo (oral softgel capsule of TU) and subsequent submission of an NDA to the FDA (that means a potential first to market benefit). Additionally in the course of the yr, Acrux introduced a generic model of Axiron Topical Resolution had been launched in america by Perrigo Firm (data out there in Lipocine’s quarterly filing).
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