jelly, re- reuse of Iplex vials & costs
Each Iplex vial contains only 0.6 mL. That's just enough for one 25 kg child at the average dose of 1.5 mg/kg, which is about the middle of the dose range to which alot of iPlex kids will be titrated. Not much left there for a second dosing from the same vial for all but the smallest kids.
Long term stability is not the determining factor for FDA allowing a 2nd dose to be withdrawn from a single vial. It's day-to-day microbial contamination from more than one "stick" through the vial stopper.
Although Iplex derives big safety benefits from NOT having a preservative, FDA does not allow multiple uses of a non-preserved vial. It's too risky, especially with a home-use injectable.
That's clearly a big reason why Insmed limited the per-vial dose to 0.6 mL (36 mg) to begin with - they did not want users to be wasting product. So that part is consistent with your point about being sensitive to the cost of "unused portions".
The silly thing about yesterday's Tercica PR relative cost claim vs Iplex is that they have misrepresented the true costs just to score a superficial benefit. To boot, they have graphically demonstrated to the world that Increlex CANNOT be safely/effectively dosed anywhere near the daily IGF-1 level of Iplex!
How stupid. TRCA really does seem to be grasping at straws as Iplex marches ahead.
Tercica used unequivalent max daily doses to make their comparison. When we dose-equalize using Tercica's own PR table as a basis, (0.24 mg/kg IGF-1 = 1.2 mg/mL iPlex, not 2.0 mg/kg as cited by TRCA), this is the true result -
KG Increlex Iplex
10 $12,319 $19,710
15 $18,478 $19,710
20 $24,638 $19,710
25 $30,797 $39,420
30 $36,956 $39,420
35 $43,116 $39,420
40 $49,275 $59,130
AVER $30,797 $33,789
Instead of claiming 100% higher cost, the true cost difference over the entire dosing range & weight range is actually only about +10%. This is exactly in line with Insmed's public statements. What a ridiculous piece of hype Tercica is trying to float!
Insmed doesn't need to increase the per-vial quantity of iPlex - it would increase the "used portion" issue. They do need to speed availability of the room-temp stable formulation or at least a refrigerator-stable product. This is the only advantage Increlex has left, and it will be going away with the improved Iplex.
Whichever way ones looks at it, Iplex has put Increlex in a very tough spot. The Insmed science & end product superiority will win out.
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