ImClone: Non-Justifiable Scientific Downgrades Refuted

The recent findings of clinical trials on the safety and efficacy of ImClone Systems' (IMCL) Erbitux in regard to advanced colo-rectal cancer refute the frivolous claim/downgrade by Friedman, Billings Ramsey & Co. analyst Jim Reddoch.

The above mentioned analysts, who have absolutely no medical training in evaluating clinical trials, cited the following concerns:

1. Though the response rate for the Eibitux in combination with chemotherapy hit 52 percent versus 38 percent for patients treated with chemotherapy alone, survival rates did not significantly differ between the two groups.

Contrary to what the analysts state above, on June 3, 2008, according to results shown at the American Society of Clinical Oncology conference in Chicago, Erbitux and chemotherapy given to colorectal cancer patients not only produced a dramatic increase in the treatment response rate, but increased the survival rate by 26% compared to subjects who received chemotherapy alone. Moreover, statistical variance analysis on the methodology of the trial's design did not suggest any shortcoming factors, such as placebo affects or lack of variable controls.

Furthermore, In addressing the analysts' concern regarding the insignificant survival rates between the two groups in the study, it's important to note that the study involved 238 people, though it was originally meant to enroll 2,200. Results were obtained from a cancer and leukemia Group B randomized clinical trial (CALGB-80203) of ERBITUX in the treatment of patients with previously untreated metastatic colorectal cancer. An expert in the field of clinical trials would understand that he number of subjects tested was considered a small population and was well below the average of 560-- which the majority of phase 3 clinical trials enroll.

Because enrollment was closed at 238 patients, the results represented only 11% of the intended power to account for an evolving standard of care. Simply stated, the survival and progression free survival endpoints were not sufficiently powered to reach statistical significance. That said, analysts from both firms were wrong in advising clients that results from this study could foreshadow other similar studies on Erbitux in combination with other treatments.

This assumption is not only un-scientific, but also without constructive criticism. Allen Venook, M.D., Professor, Clinical Medicine, University of California, San Francisco, was the principle investigator in the study.

2. The data calls into question Erbitux's long-term value and could diminish the likelihood of an acquisition with a significant premium.

The long term value of Erbitux is evident by its safe and efficacious data, which proved to prolong the lives of the terminally ill. As to the likelihood of an acquisition, if a bid of 60 dollars/share (rise from a 6-month average of 41) is not significant, I don't what is.

Moreover, in the most recent study, Markus Borner, M.D., of the Institute of Medical Oncology, Inselspital, Berne, Switzerland, presented preliminary results from a Swiss Group for Clinical Cancer Research randomized Phase II study of capecitabine and oxaliplatin with or without ERBITUX as first line treatment of patients with metastatic colorectal cancer.

Objective response rate was the primary endpoint of the study. A total of 74 patients were recruited for the study and evaluable for preliminary response after follow up for at least nine weeks. Following a median of four treatment cycles, response rates were 43% (21/44) in the chemotherapy alone arm and 61% (23/44) in the combination ERBITUX and chemotherapy arm. The rate of disease control was 76% and 87% in the chemotherapy and chemotherapy plus ERBITUX arms, respectively.

Disclosure: none

Comments

[nova:]

Jack,

You are absolutely correct. It appears that these analysts are just paid spin-artists with the deliberate agenda and/or intensions to spread misleading, false and unsubstantiated rumors and innuendoes regarding to ImClome Systems and its lead drug Erbitux. By doing so, these analysts doing great disservice to investment public and cancer patients who could, otherwise, be treated with Erbitux capable of not only prolong their lives but also offer some patients cancer-free survival through surgical resections and complete responses.

I am really impressed by Morgan Stanley analyst Harr. Prior to and after ASCO 2008 conference, Harr issued numerous "research" papers stating Cairo II clinical trial was a failure on par with PACCE trial.

Let me remind to readers that PACCE trial tested a combinations of chemotherapy+Avastin+/... Vertibix in 1st-line metastatic colorectal cancer (mCRC) patients. This trial has been stopped very early due to safety issues since the death rate for patients in the Vertibix added arm was significantly higher than in a control arm that did not have Vertibix.

At the same, Cairo II trial that tested the same patients population with the same chemo regiment+Avastin +/- Erbitux has been completed. No serious safety issues were identified with addition of Erbitux to the chemo regiment plus Avastin. Unfortunately, for wild-Kras patient population [these are only mCRC patients benefiting from EGFr-drugs like Erbitux and Vertibix], Cairo II clinical results regarding to Progression Free Survival (PFS) and Overall Survival (OS) were the same for both control and Erbitux arm.

Consequently, addition of Erbitux to the chemo regiment plus Avastin did not offer any additional benefits to cancer patients but also did not create any serious safety issues that led to PACCE trial early termination.

In spite of all this, Mr. Harr "research" trying to equate PACCE and Cairo II clinical trials results is just preposterous.

I would not be surprised if these "analysts" are somehow connected to the highly low Bristol-Myers takeover bid for ImClone. I will not be surprised to learn that the investment houses these analysts are working for are like "to do business" with Bristol-Myers.

These misleading and false "research" reports regarding to oncology drugs and specifically to Erbitux MUST stop. These reports harm both investment public, medical community and cancer patient population.

The harm is too great to be allowed to continue!

2008 Aug 06 04:22 PM

[hoopdreamer...:]

I definitely agree with your sentiments.

Only thing to point out, your %'s cited here are wrong. Its 48% vs 52%, not 43 and 61%.

<<Following a median of four treatment cycles, response rates were 43% (21/44) in the chemotherapy alone arm and 61% (23/44) in the combination ERBITUX and chemotherapy arm.>>

2008 Aug 07 09:44 AM

[Jack Haddad:]

No, thanks for your vote of confidence in the subject matter. Unfortunately, more often than, analysts behave like high class prostitutes-- corporate cheerleaders!

2008 Aug 07 04:54 PM

[Jack Haddad:]

Jose, thanks. You stand correct on the percentages.

2008 Aug 07 05:00 PM