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Replies to #91069 on Biotech Values
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mcbio

02/23/10 9:10 PM

#91074 RE: DewDiligence #91069

Re: WPI CC (generic Lovenox)

(MNTA TEVA): WPI appears to have dismissed any hope of Amphastar’s obtaining FDA approval for generic Lovenox. Here is what WPI’s CEO, Paul Bisaro, said about Lovenox on today’s CC in reply to a question by Cowen’s Ken Cacciatore:

seekingalpha.com/article/190186-watson-pharmaceuticals-inc-q4-2009-earnings-call-transcript
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Regarding Lovenox, Ken, I don’t really have enough insight to give you any valuable read on Lovenox. As you know our partner, Amphastar is the one who deals directly with the agency and we don’t really participate in those conversations, so we don’t have the sort of direct hands-on knowledge. I think others like Momenta, Teva have probably more direct knowledge.
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Do you say that because, if Amphastar had any inclination that its generic Lovenox were near approval, it would have shared that with its partner (WPI)? I.e., the fact that WPI indicates that it has no clue where Amphastar's generic Lovenox stands may be read as a sign that it's likely nowhere near approval. Obviously MNTA has been pretty clear that it feels it has addressed all of the FDA's outstanding concerns.
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randychub

02/23/10 9:27 PM

#91077 RE: DewDiligence #91069

MNTA - Thanks Dew! Is there a change in the financial terms for 2 vs 3 companies getting approval?

Randy

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turtlepower

02/23/10 10:33 PM

#91082 RE: DewDiligence #91069

I think the question and answer after that exchange is also telling.

Ken Cacciatore – Cowen and Company

They are not ramping you up for a launch, I guess, is that the best way to phrase it?

Paul Bisaro

I would say that’s probably fair.