Biotech Values

[DewDiligence]

Re: Copaxone bioequivalence

[Teva says]: “…rendering a bioequivalence study comparing two formulations [of Copaxone] extremely difficult.”

Solving difficult problems is MNTA’s raison d’etre, is it not?

Peptimmune, who filed a Citizen Petition with the FDA vis-à-vis generic Copaxone, claims that developing PK/PD assays for Copaxone is a solvable problem. Indeed, Peptimmune claims to have solved it. From page 12-13 of Peptimmune’s CP (http://www.peptimmune.com/uploads/news/peptimmune_citizen_petition_1012010.pdf ):

We have established that a fraction of GA [glatiramer acetate] is systematically delivered in the circulation. This finding is consistent with Teva’s own data as previously discussed. We have identified human proteins responsible for stabilizing GA fractions in serum. We have developed an assay to measure the pharmacokinetics of both amino acid copolymers and to correlate systemic exposure with in vivo effects of amino acid copolymers on the innate immune system.

…From this analysis, it appears that GA fragments reach maximum serum concentration of 1800ng/mL at around 15 min post dosing. The estimated bioavailability of Copaxone administered SC was 12% as compared to Copaxone administered IV. GA fraction was still detected in serum at 2 hours post-dosing. A linear correlation between dose and serum exposure has also been established.

In short, Teva’s contention that this can’t be done is bullshit, IMO.