Replies to post #108146 on Biotech Values

[linhdtu]

I believe you've hit the nail squarely on the head.

I know you are only speculating, but your logic/reasoning makes very good sense to me.

[mcbio]

First, I believe you may have just set the record for longest post on iHub. But more importantly, great post! I think you make a lot of good points.

[jbog]

Tinker,

I think we're somewhat forgetting that in 2003 there never was a drug held up to this kind of scrutiny. At that time the FDA accepted drugs that were within a certain tolerance, and I'd guess that Teva drug is within that tolerance.

What really happened is that the rules changed and now Teva is stuck with both feet in.

Did Teva do the homework that Momenta did? Absolutely not, but again they never would have spent maybe a couple of hundred million bucks to achieve that goal.

Now with Teva stuck in this fight I'm sure they'll just let it diminish over time and hope everyone forgets about it. Time is Teva's best friend right now.

Sooner or later we'll see what Teva's real strength is when we see their legal side.

By the way, Teva probably holds one of the best returns for its stockholders over the last 20 years. Somewhere around a 7000% return without counting the divs.

[ghmm]

They target enoxaparin, which may be 2-3-4%, at most to their bottom line.

2% of TEVA > 100% of MNTA
3% of TEVA > 150% of MNTA
4% of TEVA > 200% of MNTA

I am long MNTA and hope Teva does not get a generic approved soon but respect what RockRat, genisi, Peter and others are trying to point out. If one also considers biologics and the market opportunity for generics there and I think people here agree it will require more technology then "unsophisticated drugs" why wouldn't Teva have spent at least 2-3-4% there.... which is a huge amount in Momenta's eyes :-).

[y3maxx]

tinkershaw...appreciate your post.

...Teva lost a major battle last July, yet to this point, it continues to successfully convince MNTA longs they lost.

[RockRat]

Look, just because the FDA went public with the 5 criteria 3 months ago does not mean the applicants weren't aware of these criteria till then. In fact, I'd say it is highly likely that all the applicants were aware of these criteria several years ago.

Amphastar and HSP also have dissimilar drugs. They may be way off on molecular weight or they may not. No applicant has offered any public comment about that. But Dew is offering a public assertion that Teva is still using a drug that is dissimilar in a very basic way. And I am just saying it is likely that the FDA told Teva several years ago that it was not approvable.

So, has Teva attempted to meet the criteria with a different process (drug) since then? Or is it simply going to pretend, amid growing skepticism as the months roll by, that their application will be approved any day, which would make them look like idiots? In the end, does Teva lose more credibility in this fashion, or by publicly admitting they cannot do it?

I think it is more plausible that they never started with a process (drug:Lupenox) that was so far off in molecular weight. genisi's digging to date also points that way.

All 3 applicants are behaving similarly, but if we take Dew's assertion at face value, Teva is behaving much more stupidly than I am willing to believe, much as I'd like to.

Regards, RockRat

[HattieTheWitch]

Tinker,

What an impressive, enlightening, well-reasoned post. Thank you.

I'd gladly use two of my fifteen free daily posts to say so again, but I hope this one suffices.

Thanks again.

[biomaven0]

unsophisticated drugs (which copaxone largely is in the scheme of things)

You have to be kidding, right? Copaxone has to be among the most sophisticated drugs I know of, both in terms of its composition and its mode of action.

Personally I think the chance that Teva is pushing Luponex under a different name and claiming that it meets the FDA's five standards is close to zero. I continue to believe that enox presents a bigger opportunity for Teva than virtually any other generic for the obvious reason that its sales would not fall off a cliff after a 6 month exclusivity period like all their other generics.

But at this point I think everyone is flogging a dead horse here. Trying to parse the Teva statements word for word and pause by pause only gets you so far.

A more productive discussion in my view is pushing the investment community to think about holding a small amount of MNTA as an insurance policy on their Teva holdings against a copaxone approval. It's not a crazy strategy by any means if you look at the numbers.

Peter