Erbitux Cetuximab - lung cancer



http://www.reuters.com/article/ousiv/idUSL1180524020070911
ImClone's Erbitux extends survival in lung cancer
Tue Sep 11, 2007

By Ben Hirschler and Toni Clarke

LONDON/BOSTON (Reuters) - The cancer drug Erbitux unexpectedly extended
survival in a trial of patients with advanced lung cancer, sending shares
of its maker, ImClone Systems Inc. (IMCL.O: Quote, Profile, Research),
soaring more than 24 percent.

Data from the trial, which was conducted by ImClone's European partner
Merck KGaA (MRCG.DE: Quote, Profile, Research) and released on Tuesday,
showed that Erbitux, in combination with chemotherapy, lengthened survival
in patients with advanced non-small cell lung cancer, the most common
kind, compared to chemotherapy alone.

"This is a huge surprise," said Han Li, a biotechnology analyst at
Stanford Group in New York. "Many did not expect the study to work."

Investors had lowered their expectations following disappointing results
from an earlier study, released in July.

The latest trial could form the basis of marketing applications in both
the United States and Europe, analysts said.

"Non-small cell lung cancer sales could easily add $500 million in
worldwide Erbitux sales," said Geoffrey Meacham, an analyst at JP Morgan.

ImClone executives were not immediately available for comment.


<
http://blogs.wsj.com/health/2007/09/11/erbitux-helps-lung-cancer-patients-but-details-sketchy/

September 11, 2007, 10:17 am
Erbitux Helps Lung Cancer Patients, But Details Sketchy
Posted by Jacob Goldstein

In a result that was better than expected, Imclone System?s cancer drug
Erbitux extended survival in a study of lung cancer patients, the
companies that sell the drug said.

Erbitux is approved for cancers of the colon, head and neck, but not for
lung cancer. So it would be a big deal if the results prove strong enough
to win approval of the drug for lung cancer. That?s a significant ?if? ?
the companies have yet to release the details of the study, so it?s
unclear just how much longer patients taking the drug lived.

The study, conducted by Merck KGaA (the other Merck), which sells Erbitux
overseas, compared how patients who received the drug along with the
chemotherapy drugs vinorelbine and cisplatin fared compared with those who
received chemotherapy alone. The results were something of a surprise.
In a recent-lung cancer trial by ImClone and Bristol-Myers Squibb, which
sell Erbitux in this country, the drug failed to meet the study?s primary
goal of improving progression-free survival.

Genentech?s Avastin, another targeted biotech drug, is already approved to
treat lung cancer in some patients. A few analysts weighed in this morning
on what the new study results could mean for both companies.

* Bear Sterns?s Akhtar Samad was especially bullish on the results,
upgrading ImClone to outperform and putting peak sales at a possible $1
billion by 2012.
* Others were more tentative. ?Given recent disappointing data, we do
not believe that Erbitux will unseat Genentech?s Avastin in this setting
and expect it to gain modest share,? wrote Citigroup?s Yaron Werber.
* Goldman Sachs?s May-Kin Ho said that if the detailed data are good,
the drug could win FDA approval for lung cancer in the second half of next
year. Ho predicts that the impact for Genentech would be minor, because
Erbitux would likely be used on a group of patients with a type of lung
cancer that cannot be treated by Avastin.



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