Amarin (AMRN) announced Friday morning that a Phase I trial comparing the bioavailability of components from a fixed-dose combination of Vascepa plus rosuvastatin, to concomitant administration of the two agents independently, and to rosuvastatin alone successfully demonstrated “promising results” according to the company. The stock is up 3% in pre-market trading on the news.
The 48-patient trial of AMR-102 (the fixed-dose combination of icosapent ethyl and rosuvastatin) was assessed versus simultaneous administration of the individual agents, as well as versus rosuvastatin monotherapy, on pharmacokinetic measurements in order to show feasibility of the fixed-dose combination. There was no inhibition of either the rosuvastatin bioavailability, or of the bioavailability of the active metabolite eicosapentaenoic acid from Vascepa, observed with the fixed-dose combination product compared to the other arms of the trial.
Amarin is eating a little crow this morning, as rosuvastatin is marketed by AstraZeneca (AZN) as Crestor. Last month, AstraZeneca bought Omthera Pharmaceuticals (OMTH) for Epanova, Omthera’s own ultra-pure fish oil pill, like Vascepa. Epanova has completed Phase III clinical trials and is set to be submitted for U.S. regulatory approval around the middle of this year for the treatment of very high triglycerides. Comically, AstraZeneva also plans to test a fixed dose combination of Epanova with Crestor (rosuvastatin). Rosuvostatin loses patent protection in 2016, around the same time that AMRN expects to bring its fixed-dose combination to market, thus the combination is a viable option for Amarin.
Here’s what we said to PropThink’s Premium subscribers on Thursday morning following Amarin’s big reveal regarding a FDA advisory panel date:
…Last week we laid out the thesis behind buying shares near their 52-week lows, ahead of the potential panel meeting. That article can be seen here, which fleshes out fully why we believe Amarin’s impassioned following will generate a run-up into the Fall advisory panel. The October 16th event is just four months away and AMRN hovers just above its $6.25 52-week lows. We’re closing in on the three-month “sweet spot” that run-up traders like so much.
As we pointed out, we expected the stock to continue lower this week following yet another month in which the FDA failed to decide on Vascepa’s exclusivity status. On Thursday morning as the market prints a red tape, AMRN touched $6.26 momentarily before bouncing back to the $6.50 area. We like that ~$6.25 held up as support even in a bearish environment, and we took the opportunity to initiate a small position, with the understanding that we’ll add if AMRN breaks down and approaches what we expect will prove another support level at $6.00.
Amarin bulls have been touting the results of this combination trial as a major event for the drug developer. We’re not convinced that’s the case, nevertheless the event adds fuel to the fire for a rally into the October AdCom. You can read more about our expectations for AMRN in our previous coverage here.
In connection with AMRN, PropThink has taken a long position.