Replies to post #86100 on Biotech Values

[DewDiligence]

When Teva wants to offer a new delivery option for Copaxone (ie, the autoject2 is now available to use with the prefilled syringes), what sort of regulatory filing process is required? I.e., if Copaxone was another Teva-Antares partner product, what regulatory path would it take?

The answer to both questions is a supplemental NDA.

[DewDiligence]

Re: MNTA / Teva’s use of AIS injector

The advantages [of AIS’ injector vs branded Lovenox] I can think of off the top of my head are:
1) no…handling of an exposed needle required
2) perhaps the injection is a bit easier (I notice Copaxone for example has a FIFTY page PDF guide to giving yourself the subcutaneous injection)

Lovenox comes in a prefilled syringe, so Lovenox users in an outpatient setting do not have any cumbersome prep work. Copaxone is unusual in the degree of care required for proper self-administration; the Copaxone guidebook you cited is not germane to Lovenox.

The above is not to say that your hypothesis regarding Teva and AIS is necessarily wrong, but rather that you have not come up with a valid reason why Teva would complicate its Lovenox application by deliberately introducing a change to the injection device. On the other hand…

Under the scenario posited in #msg-43206942 in which Teva expects the FDA to approve Teva’s version of Lovenox as a non-substitutable branded product, Teva’s using a differentiated injector such as the one from AIS would make perfect sense.