Replies to post #91039 on Biotech Values

[DewDiligence]

AMLN Takeda:

…each drug is being injected twice a day so patients get 4 injections per day. If this formulation does not improve, I don't think too many people will accept the treatment.

Is there any reason why these two drugs couldn’t be given in a single injection during late-stage trials and commercial use?

[north40000]

AMLN/Takeda: I have no complete answer for your concern currently

Might be well to check with AMLN on our reading of clinical trials as requiring 4 injections/day, 2 each of P and mL. Ambiguous, IMO, particularly in light of the following statement:

>>Examine safety and tolerability of treatment, and effect on body weight of various doses of metreleptin and pramlintide, administered alone or in combination (as separate SC injections), in obese and overweight subjects. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]<< What does 'in combination' mean? Can P and mL be mixed, and the mixture then be administered twice/day?

Perhaps represents a Hobson's choice for the patients: lose weight with "x" injections/day, or face ensuing T2 diabetes potential with continuing weight gain and age + all the potential AEs accompanying same. I note there did not appear to be many drop-outs in the 26 or 52 week trial.

Beside the point, but as a T1 diabetic I inject insulins at least twice, sometimes thrice a day; always a mix of Humulin and Humalog in morning and titrate evening one or both as necessary to maintain HbA1c and fasting bs control. 53 years so far of accepting that kind of treatment--you know the alternative. Humalog has made things easier.