This post will attempt to refute the unwarranted downgrade by Friedman, Billings Ramsey & Co. analyst Jim Reddoch, following the late-stage clinical trial results of Erbitux that were released on June 6, 2006.
Both Fridman, Billings Ramsey & Co and Citigroup cited the following concerns as justification for downgrade:
1. Though the response rate for the drug 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.
2. The data calls into question Erbitux's long-term value and could diminish the likelihood of an acquisition with a significant premium.
3. Competition is now a factor in regards Genentech's Avastin, which would not be able to replace in front-line treatment, except under certain circumstances.
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.
The number of subjects tested is considered a small population and is 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. Therefore, it very clear that the powering of the trial was inadequate to draw firm conclusions. 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.
As to ERBITUX's long-term value being in question, the documentation of trials on the drug's efficacy puts this matter to rest. 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.
On a different note, ERBITUX have pushed the stock's value up 25 percent over the last 8 weeks. I continue to think that Imclone has an underappreciated cancer pipeline. The company is also in the midst of several other developments, working on drugs targeting cancer ranging from pancreatic to ovarian. This asset is not fully appreciated by many investors, in my view, and I continue to believe that the Street is overly pessimistic on the potential for Imclone to be acquired. I expect peak sales of Erbitux in the U.S. to top $1 billion. The company is also in the midst of several other developments, working on drugs targeting cancer ranging from pancreatic to ovarian.
On a persoanl note, Carl Icahn bought another $7,032,750 worth of IMCL last week and now controls 10.37% of outstanding shares. See link for details at:
http://sec.gov/Archives/edgar/data/765258/000092847506000167/xslF345X02/form4060806_ex.xml