Roger, your take?
Regards,
Tom
thestreet.com
mClone's Erbitux Problems May Be Worse Than
Believed
By Adam Feuerstein
Staff Reporter
01/07/2002 12:23 PM EST
Shares of ImClone Systems (IMCL:Nasdaq - news - commentary - research -
analysis) sank more than 17% this morning after a cancer newsletter said the
company is having more serious problems with its experimental cancer drug,
Erbitux, than previously disclosed.
The Cancer Letter, a Washington, D.C.-based newsletter, claims to have obtained
a leaked copy of the "refuse to file," or RTF, letter sent by the Food and Drug
Administration to ImClone late last month. The letter details the concerns and
problems regulators have with the approval application for Erbitux.
Based on the negative disclosures in The Cancer Letter, JP Morgan downgraded
ImClone Monday to market perform from buy. The firm now believes that ImClone
will not be able to refile its Erbitux application in the first half of the year, as the
company predicts. Instead, the application will be delayed until late in the year due
to the need for additional clinical information.
Shares of ImClone are off $7.79, or 17.9%, to $35.70 per share in recent trading.
On its Dec. 31 conference call, ImClone executives said that FDA regulators sent
the RTF letter because the Erbitux application was missing certain "train of
documentation" information needed by regulators to accept the filing. ImClone said
it would be able to answer the FDA questions by the end of the first quarter,
leading, hopefully, to an approval of Erbitux in the fall.
But The Cancer Letter says it has a copy of the nine-page RTF letter, and the
problems are more serious, involving the structure of the Erbitux clinical trials.
TheStreet.com has obtained a copy of the Jan. 4 issue of The Cancer Letter, which
details the contents of the RTF letter.
The RTF letter states that the pivotal clinical trial for Eributex was not "adequate
and well controlled," according to The Cancer Letter. Every patient in the trial was
given a combination of Erbitux and irinotecan, also known as CPT-11, an existing
chemotherapy drug. But in its RTF letter, the FDA concludes that the trial was not
designed to "demonstrate the contribution of CPT-11 to the regimen," according to
The Cancer Letter. The RTF letter also suggests that new clinical trials would be
required to provide more robust data proving the efficacy of Erbitux and its
suggested dosing, according to The Cancer Letter.
Furthermore, the FDA, in its RTF letter, is concerned about protocol violations in
the clinical trial, specifically the fact that ImClone only reported on the deaths of
three patients who died within a month of their last Erbitux treatment. The FDA
found 21 patients who died within a month of their last Erbitux treatment, according
to The Cancer Letter.
It is impossible at this point to verify the veracity of The Cancer Letter disclosure.
The newsletter's authors contacted ImClone CEO Sam Waksal, who said, "The
exchange between the agency and us is right now a confidential exchange,
because we are working with the agency to try and put together a response that
allows us to move forward with our BLA. We didn't release the letter, so whatever
you have, you have from an illegitimate source." Company officials could not be
reached for further comment Monday.
But if The Cancer Letter does have a correct copy of the RTF letter, it suggests
that ImClone executives have not given investors and Wall Street analysts a full
picture of the Erbitux problems.
According to The Cancer Letter, the RTF letter from the FDA clearly states that
new Erbitux studies will be needed, something that Waksal has denied.
The pivotal trial was not "adequate and well controlled," the RTF letter states,
according to The Cancer Letter. "Because we have determined that the current
study is not adequate and well controlled and that the robustness of the overall
response rate is less than is stated in the study reports, you will need to conduct
additional studies to provide this evidence."
The FDA then goes on to suggest a randomized and controlled clinical trial that
would compare Erbitux by itself to a combination of Erbitux and irinotecan in
patients who can be documented to have failed prior irinotecan treatments,
according to The Cancer Letter .
The RTF letter is signed by Karen Weiss, director of the FDA Division of Clinical
Trial Design and Analysis, and Kathryn Stein, director of the Division of Monoclonal
Antibodies. |
