Delay in Quick Shot Testosterone Clinical Program is Not a Major Setback for the Stock (ATRS, Buy, $2.53)
Antares sent out a press release today about a new development in the Quick Shot Testosterone phase 3 program. The Company said that based on a single reported occurrence of hives in the completed phase 2 study, which the FDA characterized as an apparent allergic reaction. The agency  is recommending that the Company create a larger safety database for the ongoing phase 3 trial. Antares does not believe that the single adverse event of hives reported in the phase 2 study was related to the drug, but rather is an issue that occurs with testosterone injections in general.
The FDA is recommending that the Company create a safety database of approximately 350 subjects exposed to QS T with 200 subjects exposed for six months and 100 subjects exposed for a year. On a preliminary basis, the Company anticipates that it may need an additional 70 patients exposed to QS T for six months.
The amount of additional time needed to complete the phase 3 trial was not stated, but I would guess that it could be nine to twelve months. It might be possible to submit the NDA before all of the safety data has been collected. If so, the delay in regulatory submission and approval could be less than nine to twelve months. The Company is scheduled to speak at the JP Morgan Healthcare conference on Thursday and perhaps we may hear more at that time. The Company continues to expect to release top-line pharmacokinetic data from the current phase 3 study in 2Q, 2015.
I see this as a modest setback and it does not affect my Buy recommendation on the stock. FDA induced delays are a common occurrence in drug development as the agency rightfully wants to make sure that safety and efficacy of a drug are defined to the maximum extent possible in clinical trials. The occurrence of the hives case appears explainable and not related to QST, but the FDA wants  to be cautious.
I continue with my Buy recommendation. A delay of even a year in the timing for approval of QST would not affect my judgment. The key events for 2015 are the progress of the Otrexup introduction and the possible launch by Antares and Teva of an AB rated product to EpiPen. I believe that the stock will still perform very well in 2015.
Tagged as .Delay in Quick Shot Testosterone Clinical Trials, Antares Pharma Inc., ATRS + Categorized as Smith On Stocks Blog
Larry,
Is the FDA asking for Antares to modify their current phase 3 trial to simply expand the patient base from 250 patients to 350 patients? Or, are they asking for a completely new group of people who are not involved with their current phase 3 trial?
Adding additional 6 month people to the existing phase 3 trial (and I’m assuming that also means extending some currently enrolled trial patients from 6 months to 12 months to obtain the “100” number) doesn’t sound very disruptive to me, if in fact that’s what Antares has been asked to do. If all they need to do is add more 6 month people, those could be added and concluded yet this year.
Thanks for your help
I am not clear on what Antares will do to address this issue. Your interpretation could be correct. we may hear more detail on Thursday when they present at JP Morgan.