IMCLONE??? - 500 Beiträge pro Seite

[Luisito]

Was ist mit Imclone los? Minus20%!!!!!!!!!!!!

[FLOTSAM_AND_JETSAM_US]

Merk will sich nicht an ausgedehnten Tests beteiligen,darauf aber hatte IMCL nach der FDA Ablehnung gehofft

Thursday May 16, 7:37 am Eastern Time
Reuters Company News
Germany`s Merck says won`t widen cancer drug trial

DARMSTADT, Germany, May 16 (Reuters) - Germany`s Merck KGaA said on Thursday it did not plan to enlarge a trial for cancer drug Erbitux which partners ImClone Systems and Bristol-Myers Squibb Co. (NYSE:BMY - News) are developing in the United States.
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A larger trial might have helped the New York companies gain approval for the drug in the United States after U.S. regulators rejected ImClone`s (NasdaqNM:IMCL - News) application late last year, citing missing data.

The refusal triggered a 70 percent plunge in ImClone`s shares and an eventual change in terms of a deal between biotech company ImClone and its larger drug partner Bristol-Myers.

Last month Merck (XETRA:MRCG.DE - News) delayed filing for European approval for Erbitux to the first half of 2003 from the second half of this year as partner ImClone Systems Inc. faced its raft of U.S. regulatory problems.

It is not yet clear if the U.S. Food and Drug Administration (FDA) will demand a new trial by the U.S. partners or settle for clinical data from European trials being conducted by Merck.

"We`ve talked about potential changes to our European colorectal cancer study," a Merck spokesman said on Thursday, adding that the three companies decided against the move.

He declined to give details.

By 1125 GMT, Merck shares were up 2.16 percent at 34.12 euros compared with a 0.19 percent gain on the pan-European DJ Stoxx health index (Zurich:^SXDP - News).

Business daily Handelsblatt reported that Merck had considered widening its trial on Erbitux to 500 patients from 300 in exchange for co-marketing rights in the United States.

The paper, citing sources familiar with talks between FDA, ImClone and Bristol-Myers, said the two U.S. companies would therefore not be able to use Merck data to secure U.S. approval.

Merck wants to get Erbitux -- also known as C225 and cetuximab -- on the market in Europe in 2004. It plans to file for European approval in the first half of 2003 with its own data for both colorectal and head-and-neck cancer.

[wankel2000]

http://wsrn.com/apps/news/art.xpl?id=4404605&f=NEWS&s=IMCL



wer kann es übersetzen und kurz zusammenfassen?

danke.

[cortezthekiller]

ImClone = ImClown - seid ihr schwul, oder was???

[wankel2000]

http://translate.google.com/translate?u=http%3A%2F%2Fwsrn.co…

[mr.Seefeld]

Die Geldvernichtungsmaschine pur. Geht lieber in Lam!

[laserjet]

außerdem sehr schlechte Zahlen (1. Quartal)

gruss
laserjet

[tanka]

Aber vom Low schon einiges wieder aufgehohlt.

tanka

[gholzbauer]

11:56AM Imclone: Merck KGaA statement on Erbitux a mistake-- CIBC (IMCL) 13.31 -1.74: -- Update -- CIBC World Markets spoke with IMCL and the co indicated that the statements made by Merck KGaA (see 7:01 comment) were a mistake and will be publicly clarified; reiterates BUY and $34 target.