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Wed Mar 1, 2006 7:45 PM ET
By Susan Heavey and Bill Berkrot

WASHINGTON/NEW YORK (Reuters) - U.S. regulators on Wednesday approved
ImClone Systems Inc.'s colon cancer drug Erbitux to treat head and neck
cancer in cases when surgery is not an option or standard chemotherapy
fails.

Approval by the U.S. cooking.net">food and Drug Administration for the additional use
of Erbitux provides an immediate shot in the arm for ImClone as it
triggers a $250 million milestone payment to the biotechnology company
from marketing partner Bristol-Myers Squibb Co. as part of their 2001
deal.

It also marks the first new therapy for head and neck cancer since the
1950s.

"We consider this approval an important advance in the treatment of head
and neck cancer because it has been shown to help some patients live
longer," said Steven Galson, head of the FDA's drug division. "Patients
need as many effective treatment options as possible."

The agency estimates about 29,000 new cases of the cancer occur each year
in the United States.

German Merck, which sells Erbitux in Europe under a licensing agreement
with ImClone, said last week it expects European regulators to also
approve the drug to treat head and neck cancers.

ImClone, which last month said it was exploring the possibility of selling
the company, reported fourth-quarter Erbitux sales of $121.2 million.
Under terms of its deal with Bristol, ImClone gets about 39 percent of
Erbitux sales revenue, analysts said.

Brian Rye, an analyst for Janney Montgomery Scott, estimated head and neck
cancer will bring additional annual sales of between $300 million and $400
million within four or five years.

"Head and neck is a smaller indication than colorectal cancer, but it's a
sizable market and there's not a lot out there in terms of novel
treatments," Rye said.

Erbitux has faced fierce competition from Genentech Inc.'s colon cancer
drug Avastin, which has seen sales far surpass those for the ImClone drug.
Avastin had fourth-quarter U.S. sales of $359.1 million.

The FDA said it based its decision on a study that showed Erbitux with
chemotherapy could help some patients live 20 months longer than with
radiation alone.

On its own, Erbitux helped shrink tumors by 13 percent for an average of
six months.

The drug was approved in combination with chemotherapy for when surgery is
not an option, and as a stand alone treatment in cases in which
chemotherapy has failed, the FDA said.

While some analysts said the milestone payment and additional approval was
a boost for beleaguered ImClone, it was widely expected and shares of the
biotech company slipped more than 2 percent to $38 in after-hours trading
on Inet from their Nasdaq close at $39.

Bristol-Myers shares edge up 13 cents in extended trading to $22.90 from
their $22.77 New York Stock Exchange close.

Bristol, which owns about 17 percent of ImClone, said last month it had no
plans to acquire the New York biotech company but would cooperate with
ImClone on any sale or merger.

? Reuters 2006. All Rights Reserved.

http://patient.cancerconsultants.com/head_cancer_news.aspx?id=30708
The trial presented at ASCO was conducted by researchers affiliated with the Erbitux Head and Neck Study Group, and included 417 patients with
locally advanced head and neck cancer.

Approximately half of the patients were treated with Erbitux? plus high-dose radiation therapy, and the other half were treated with high-dose
radiation therapy only and were directly compared. After over 3 years of follow-up (38 months), the average duration of survival was 58 months
in the group of patients treated with Erbitux?/radiation, compared with only 28 months for those treated with radiation only.

Three-year overall survival was 57% for patients treated with Erbitux?/radiation, compared with only 44% for those treated with radiation only.
The only notable side effect associated with Erbitux? was skin rash.

The researchers concluded that the addition of Erbitux? to high-dose radiation therapy significantly improves survival compared to high-dose
radiation therapy alone in the treatment of locally advanced head and neck cancer.

The presenter stated that Erbitux? appears to provide comparable survival benefits to chemotherapy in the treatment of these patients, without
the side effects associated with chemotherapy.

Future clinical trials to evaluate the clinical role of Erbitux? against other therapies in the treatment of head and neck cancer or earlier in
the course of the disease is warranted.

Patients diagnosed with locally advanced head and neck cancer may wish to speak with their physician about the risks and benefits of
participation in a clinical trial further evaluating Erbitux? or other promising therapeutic approaches.

Reference: Bonner J, et al. Phase III study of high dose radiation with or without cetuximab in the treatment of locoregionally advanced
squamous cell cancer of the head and neck. Proceedings from the 40th annual meeting of the American Society of Clinical Oncology. New Orleans,
LA. 2004. Abstract #5507.

http://www.aetna.com/cpb/data/CPBA0684.html
Bonner, et al., (2004) reported on the results of a phase III trial to examine the impact of combining cetuximab with high dose radiation on
locoregional disease control and survival in patients with locally advanced squamous cell carcinoma of the head and neck.

The investigators randomized 424 patients with locoregionally advanced squamous cell carcinoma of the oropharynx, hypopharynx or larynx to
either radiation alone for 6-7 weeks, or radiation plus weekly cetuximab.

Following completion of treatment, patients were followed by physical examination and radiographic imaging every 4 months for 2 years, and then
every 6 months up to 5 years. Median survival was 54 months in subjects receiving cetuximab plus radiation therapy compared to 28 months in
subjects receiving radiation therapy alone.

The investigators noted that the overall toxicity profile was dominated by classic known effects of high dose head and neck radiation, although
some additional toxicity was attributed to cetuximab.

Significantly more subjects receiving combination therapy had grade 3/4 skin reactions (34%) than subjects receiving radiation therapy alone
(18%). Grade 3/4 infusion reactions were seen in 3% of subjects receiving cetuximab.
The investigators concluded that the addition of cetuximab to high dose radiation in patients with locoregionally advanced squamous cell
carcinoma of the head and neck demonstrated a statistically significant prolongation in overall survival. This clinical benefit was achieved
with minimal enhancement in the overall toxicity profile associated with curative-intent radiation therapy.

We've been using it in Vienna since last summer for recurrent H&N Ca.
Pretty good stuff, costs a fortune I'm told. This doesnt bother the
patients, most of whom get the treatment free via the national health
(and usuall carry on smoking).  Sometimes it causes massive skin
reactions.

--
madiba