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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: Miljenko Zuanic who wrote (522)2/5/2000 12:13:00 PM
From: biowa  Read Replies (2) of 666
 
Miljenko,

when Genentech walked away from Zev it was dead for me and no competition to Bexxar at all

An excellent point, and one everyone should keep in mind.

So where do things stand today?

Bex vs. Zev

(1)The data in Rituxan-failed patients makes Bex seem the superior molecule

(2)IDPH cannot effectively market Zev against Bex b/c they basically are locked into marketing it as salvage therapy (partially by Genentech)

(3)Bex BLA will be filed (most likely) six months ahead of Zev BLA. And if FDA has accepted CLTR argument that dosimetry is necessary Zev BLA may face some extra scrutiny. Also, it appears that Zev filing will involve both a BLA for Zev and an NDA for Y90

Net: You're right, Zev probably doesn't matter (except to the market).

Bex vs. Rit

(1) Flu+Bex vs. CHOP+Rit data would appear to give the edge to Bex. It also seems to have dampened some of the concern about HAMA

(2) IDPH has to deal with the issue of why did they develop Zev, if a naked anitbody is better than a radio-labeled one? This may force them even further into a salvage positioning for Zev.

(3) Rit has the advantage of being established

(4) Bex is radioactive, which is an issue.

Net: If efficacy is the primary issue, IMHO Rit should win, otherwise it becomes a marketing battle

biowa
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