Replies to post #116038 on Biotech Values

[10nisman]

Re: Rumored Copaxone clinical trial (follow-up to #msg-60673589)

I heard Teva was doing the trial, as Bill Marth and team want to prove to Wall Street/Analysts that it's impossible to obtain generic approval for Copaxone. :)

Dew... Approximately how long would a bio-equivalence study take (start to finish)? In your opinion, what are the chances the study is being conducted by someone other than Sandoz/MNTA? TIA.

10nis

[pollyvonwog]

DD, if indeed it turns out to be preemptive, why wouldn't Sandoz/MNTA have done it earlier?

It's also my understanding that these studies are pretty small (24-36 people) yes?

ANDAs for injected drugs ordinarily don’t need bioequivalence studies because such drugs, by definition, don’t have the variability in bioavailability that comes from variability of dissolution in the GI tract. However, it’s conceivable that the FDA may nevertheless want a bioequivalence study for NVS/MNTA’s generic Copaxone. If there is any chance of this, it would make sense for NVS/MNTA to conduct such a study prophylactically rather than getting hit with a deficiency letter later.

[RockRat]

RE: m-Copaxone bioequivalence trial:

>>ANDAs for injected drugs ordinarily don’t need bioequivalence studies because such drugs, by definition, don’t have the variability in bioavailability that comes from variability of dissolution in the GI tract. However, it’s conceivable that the FDA may nevertheless want a bioequivalence study for NVS/MNTA’s generic Copaxone. If there is any chance of this, it would make sense for NVS/MNTA to conduct such a study prophylactically rather than getting hit with a deficiency letter later.<<

Given the following (from a Teva PR, but no reason to doubt accuracy in this instance):

"Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult."

How do MNTA/Sandoz get around this?

I know this has been mentioned before, and my recollection is no one had a satisfactory answer.

Regards, RockRat