Replies to post #69193 on Biotech Values

[mcbio]

Thanks, that's helpful. So Teva responded to the same question that MNTA/Sandoz did but that doesn't necessarily equate to the FDA viewing both generics as equal.

Regarding Sanofi's potential "authorized" generic, is the belief that they likely won't introduce one due to the fact that any introduction by them essentially cannibalizes sales of Lovenox? I.e., why would someone use Lovenox if the same company that makes it has its own generic? Rather, by not issuing their own "authorized" generic perhaps they hope there will be those who question if the generics truly are equal to Lovenox. Is that the rationale?

Although it would be nice to have the only generic, as long as MNTA at least gets approval in 2009 we should be looking at a much higher price, which makes me like the risk/reward.

[jbog]

Dew,

""""The status of Teva’s ANDA is perhaps the biggest uncertainty for MNTA investors and is arguably the main reason the valuation is as low as it is."""""

Looking at the "timing" of MNTA's recent stock price, I'll guess it's the capital versus burn rate that's more responsible of the swoon in the stock price.

Every stock was re-evalulated the day Lehman Burned. The cash rich kept their heads up while the others got their heads chopped off.

[DewDiligence]

MNTA – This is what Jeff George, CEO of Sandoz, said about Lovenox on NVS’ 4Q08 CC today:

April 1 is day 181—after Amphastar’s 180-day exclusivity expires. Every day that passes, frankly, is good news for Sandoz in that Amphastar has not launched since they don’t have US approval.

The two other factors associated with [Sandoz’s] launch are the Citizen Petition from Sanofi, and we’re still waiting from the FDA for a response on that, and the heparin supply from China. Two of the four heparin suppliers we use have been cleared and we’re still waiting for the compliance audits from the others.

We may presume that the FDA will respond to Sanofi’s CP concurrently with approval of the first ANDA(s).