Biotech Values

[mouton29]

Trials expected to be required for FOB's.

This was a surprise to me, but that may just be my ignorance. The law, as quoted and summarized by Dew in http://investorshub.advfn.com/boards/read_msg.aspx?message_id=48581353 permits the FDA to waive the requirement of clinical trials, so it is not clear to me why they would not if the same degree of similarity is proven as would be required for 505(j). Perhaps the answer is 505(j) does not permit a clincial trial, whereas the FOB law only permits the FDA to waive.

Joseph Schwartz—Leerink Swann Llc

Thanks, and do you always expect to be able to get to market without any clinical data, so to speak, and is there a limit if clinical trials that you can place or you can reference as far as that so we may understand some more about your strategy here? Because it seems like a lot of the drugs which you would be reasonably expected to go after would be some of the more complex ones but then maybe that’s where the FDA might like to see more of a mix of clinical and non-clinical data so how should we think about these things in that context?

Craig Wheeler

Sure, that’s a good question. I think we—what we’ve always said is we believe in the favalon biologics pathway the trials will be required, at least at first. We ultimately, as people get more comfortable and as the technology advances, that we may get to much more like a 505j type of pathway here but certainly at first there’s going to be some sensitivity towards what clinical data is provided. We’re expecting to do trials. Our view on that is that the types of trials and the amount of trials, the size of the trials, will be limited if you actually provide the right data, the right characterization data, file characterizations, analytic characterizations to show that you actually have an equivalent product. Our strategy is to—just like we’ve done with enox and with Copaxone to show that we have equivalent product—and then the clinical trial data should become more confirmatory type data as opposed to the primary data that’s driving approval as an equivalent.

We think that the technology that we have should reduce those clinical trials. We think it should therefore enable faster approvals. We think also it should—if we have the kind of success that we think we can create here—enable us to get to substitutable biologics much more quickly. So that’s really our strategy.