Replies to post #107359 on Biotech Values

[iwfal]

Well, the cat is out of the bag. The product Teva is trying to pass off to the FDA as a generic copy of Lovenox was developed by ItalFarmaco and is manufactured by ItalFarmaco. It’s the same product Lupin sells in India under the brand name, Lupenox (#msg-56014815). Teva’s contribution is limited to FDA regulatory submissions and prospective US distribution.

As presented in #msg-55885444 and #msg-55952595, Lupenox is demonstrably different from Lovenox. The two drugs do not even have the same average molecular weight in their mixtures,

Well, I am trying to figure out if this is a Dew practical joke - I mean, if they are that different then why hasn't the FDA rejected it outright?

[Mpower]

Wow. Very interesting. This really changes the dynamics of the situation. 8 million shares short with the expectation that a Indian Lovenox knock-off will be approved any-day now. Whoops .... Can't wait to see Tim Anderson (Sanford Bernstein) with some major pie in his face.


Note: Might I suggest that Sanofi file a lawsuit against Italfarmaco for Trademark Infringement. ("Lovenox" vs. "Luponex" ... likelihood of confusion if you ask me).

[genisi]

Teva’s contribution is limited to FDA regulatory submissions and prospective US distribution.

Are you saying Teva just took the drug developed by ItalFarmaco as is and submitted an ANDA?

[Btek]

Thanks efar and DD. I have some basic questions since I have a limited understanding.

Do we know what FDA inspected in September 2010 at ItalFarmaco?

Could they have reformulated this for the US market?

[drbio45]

If this is verified, do you think it is something mnta should mention on their conference call?

[tinkershaw]

Well, the cat is out of the bag. The product Teva is trying to pass off to the FDA as a generic copy of Lovenox was developed by ItalFarmaco and is manufactured by ItalFarmaco. It’s the same product Lupin sells in India under the brand name, Lupenox (#msg-56014815). Teva’s contribution is limited to FDA regulatory submissions and prospective US distribution.

This is great detective work. My question however is how do we know that this is the fact. That Teva is using the Indian generic drug. That there is not a reformulated drug that was better refined.

My issue here is, is that someone would think if we could figure this out that someone else would figure it out, and if so, then how could the share price be this low? I held a ton of MNTA through approval. Sold, and have bought back even more MNTA, so I understandably have a great interest in this. I am thinking of buying even more on this news. Just trying to verify the source that makes this conclusion certain. I've read through all the fine posts and material on the topic but have not been able to nail down this question.

Thanks.

Tinker