Biotech Values

[pollyvonwog]

I think the quote in question comes from an email exchange with TEVA's IR I had back in Oct. I'll post the pertinent parts again below:

"It is well-known that we have partnered with another company regarding the product[t-enox]. I am not sure I understand why that would be consequential."

"Over the years, we have partnered with many companies in the development of individual products. We are very pleased with our partner for generic Lovenox."



And for giggles, here is what he had to say when I started talking about Copaxone:

"Regarding Copaxone, experience or technology allowing for the characterization or replication of enoxaparin is irrelevant in terms of demonstrating the sameness of a purported generic version of Copaxone®. Although enoxaparin is difficult to characterize, the clinically active portions of the drug can be identified; Copaxone®, on the other hand, is poorly characterized and the clinically active portions of the drug cannot be identified.

In fact, the active ingredient “sameness” criteria outlined by FDA to approve a generic version of Lovenox® without clinical trials reinforce our position that the only way to ensure a purported generic Copaxone® would have no significant clinical consequences would be to conduct pre-clinical and full-scale, placebo-controlled clinical trials with measured clinical endpoints in MS patients to establish safety, efficacy and immunogenicity in a real patient population [ie since lovenox didn't require clinical trials, then logically that means Copaxone will require them. lol]."