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$41.72 -0.97 (-2.27%)
5/16/2008 4:00 PM

ImClone Systems, Inc. (IMCL)

CAPS Rating:
***

A biopharmaceutical company which advances oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.

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Total Players

178 Outperforms
35 Underperforms
 

All-Stars

58 Outperforms
17 Underperforms
 

Wall Street

9 Outperforms
1 Underperforms
 

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Ticker Tags

Biotechnology (291), Mid Cap (670)
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ImClone Systems, Inc. At A Glance

Current Price: $41.72
Last Trade Time: 5/16/2008 4:00 PM
Open: $42.42
Previous Close: $42.69
Daily Range: $40.56 - $43.36
52-Week Range: $30.34 - $49.18
Volume: 2,514,093
Market Cap: $3.69B
P/E Ratio: 105.98
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Stock Trends

IMCL VS S&P 500 (SPY)

IMCL 12 month chart vs. S&P

News & Discussion Boards

Top Bull Pitch

Recs

4

ImClone Systems, Inc. (IMCL)

Avatar NetscribeBiotech (66.48) Submitted: 3/12/07 5:11 AM

ImClone Systems Incorporated (ImClone) is a biopharmaceutical company that is focused on development of oncology therapeutics. With various drugs in the pipeline, addressing the medical needs of patients affected with cancer, the company’s only commercial product in the market is Erbitux, which is a...More

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Top Bear Pitch

Recs

6

ImClone Systems, Inc. (IMCL)

Avatar TMFPeterJ (< 20) Submitted: 8/28/06 5:14 PM

You hate to vote against stock in a company doing something as vital as cancer research. But IMCL's track record suggests its research could produce better results in the hands of a more well-run biotech.

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0

 (IMCL)

Avatar wundermichl (34.37) Submitted: 5/13/08 12:14 PM : Outperform Start Price: $43.03 IMCL Score: -4.83

Cetuximab (Erbitux) will most likely be approved for treatment of non-small cell lung cancer. The recent downgrade by a Morgan Stanley analyst was probably derived from speculation and not actual data of the FLEX study. Extrapolating data from the primary literature published over the past years I expect the benefits of implementing Erbitux in lung, colorectal, and probably head-and-neck carcinoma to be signifcant.

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0

 (IMCL)

Avatar imobillc (69.51) Submitted: 5/12/08 1:14 PM : Underperform Start Price: $42.15 IMCL Score: 3.10

Not a Buy! Too many bad news.....
ImClone Systems Incorporated (ImClone), incorporated on April 26, 1984, is a biopharmaceutical company that develops a portfolio of targeted biologic treatments designed to address the medical needs of patients with cancer. The Company focuses on two systems for treating cancer: growth factor blockers and angiogenesis inhibitors. Its commercially available product, ERBITUX (cetuximab), is an antibody approved by the United States Food and Drug Administration (FDA). On March 1, 2006, the FDA approved ERBITUX for use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed. In addition to developing and commercializing ERBITUX, the Company has also advanced a number of investigational agents to various stages of clinical development, including those targeting angiogenesis and growth signaling mechanisms, which can be used to treat various kinds of cancer and nonmalignant diseases.

ERBITUX binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of the epidermal growth factor (EGF) and other growth stimulatory ligands, such as transforming growth factor-alpha. The EGFR is constitutively expressed in many normal epithelial tissues, including the skin and hair follicle. Expression of EGFR is also detected in many human cancers, particularly carcinomas, including those of the head and neck, colon and rectum, pancreas, stomach, lung and breast. The Company co-promotes and otherwise supports the sale of ERBITUX in United States and Canada together with its development, promotion and distribution partner Bristol-Myers Squibb Company (BMS) through its wholly owned subsidiary E.R. Squibb & Sons, L.L.C. (E.R. Squibb). It manufactures ERBITUX for clinical studies and for commercial sales. The Company has undertaken a clinical development program to evaluate the use of ERBITUX in colorectal cancer, including two Phase III randomized studies known as EMR-013 (also known as CRYSTAL) and BMS-006 (also known as EPIC). The first-line metastatic study EMR-013 met its primary endpoint by improving progression-free survival. In August 2007, the Company announced that it has received approval from the FDA for a second facility to manufacture ERBITUX. The Company continues to conduct research in a number of areas related to tumor cell growth factor inhibitors and angiogenesis inhibitors.

Colorectal Cancer

The study under colorectal cancer includes CALGB 80405, which is a Phase III randomized study of chemotherapy, with a target enrollment of 2,289. EMR-013 (CRYSTAL), a randomized Phase III study that evaluates the merits of adding ERBITUX to irinotecan and infusional 5-fluorouracil (FOLFIRI) as first-line therapy in patients with metastatic disease, completed patient accrual in December 2005. Other studies include 680 CAIRO II, COIN, SWOG, NCCTG147 and PETACC-8, which are ongoing studies. Many other randomized Phase III trials sponsored by either Merck KGaA, ImClone, and/or BMS and/or various national cooperative oncology groups in United States and Europe are evaluating the merits of adding ERBITUX to many different chemotherapy regimens with or without Avastin in the first- and second-line metastatic setting.

Head and Neck Cancer

The studies include IMCL-9815 (completed), EMR-001, EMR-008, ECOG-5397, EMR-002 and RTOG 0522. The final results of IMCL-9815, the Company's Phase III locally advanced head and neck cancer study, conducted in cooperation with Merck KGaA, demonstrated that ERBITUX, when added to definitive radiation therapy, significantly improves the duration of both locoregional disease control and overall survival. RTOG 0522, which opened to patient enrollment in November 2005, was designed to extend the positive results with ERBITUX reported from study IMCL-9815. In this Phase III study, patients with locally advanced head and neck cancer are being randomized to treatment with either radiation plus chemotherapy or radiation plus chemotherapy plus ERBITUX. The Eastern Cooperative Oncology Group (ECOG) published the final results of ECOG 5397, a randomized Phase III study of cisplatin plus ERBITUX versus cisplatin, which revealed that the objective response rate was significantly higher for the ERBITUX arm (26.3% versus 9.8%). Both overall survival and progression-free survival were higher in patients receiving ERBITUX plus cisplatin, but the study was not adequate to demonstrate clinically relevant differences in these endpoints. Based on the results of ECOG 5397, as well as nonrandomized studies demonstrating the activity of ERBITUX in patients with recurrent and metastatic head and neck cancer following treatment with platinum-based regimens, Merck KGaA developed EMR-002, a randomized Phase III study of cisplatin plus 5-fluorouracil versus cisplatin plus 5-fluorouracil plus ERBITUX. ImClone and its partners, BMS and Merck KGaA, have also begun a large number of Phase I and II studies, some of which are randomized, to evaluate the merits of adding ERBITUX to a variety chemotherapies, radiation and chemoradiation regimens in many different settings of SCCHN, including the neoadjuvant, adjuvant, metastatic, locoregional settings.

Non-Small Cell Lung Cancer

The studies under non-small cell lung cancer include CP02-0452, EMR-011, BMS-012, EMR-046, BMS-099, BMS-100, IMCL-0554, RTOG-0324 (completed), SWOG-O342 and RTOG (TBA). RTOG 0324 evaluated the feasibility, safety and efficacy of ERBITUX combined with Taxol/Carboplatin and radiation, in patients with locoregionally-advanced stage IIIa non-small cell lung cancer. In addition, the Southwest Oncology Group (SWOG) completed accrual to SWOG 0342, a randomized Phase II study evaluating combined therapy with ERBITUX/paclitaxel/carboplatin (combined) versus paclitaxel/carboplatin followed by ERBITUX (sequential) in patients with stages IIIb or IV non-small cell lung cancer. IMCL-0452 (SELECT) is accruing patients to evaluate the merits of adding ERBITUX to chemotherapy in the second-line metastatic setting. A range of both randomized and non-randomized Phase I and Phase II studies, sponsored by ImClone, BMS, and Merck KGaA, are evaluating ERBITUX in combination with many chemotherapy and chemoradiation regimens in neoadjuvant, adjuvant, locoregionally-advanced, and advanced non-small cell lung cancer disease settings.

Pancreatic Cancer

Based on the response rate, survival rates, and survival reported from a Phase I/II study of ERBITUX plus gemcitabine, as well as the tolerability of the regimen in patients with advanced pancreatic cancer, the SWOG activated SWOG-0205, a first line study in pancreatic cancer. Other Phase II randomized studies sponsored include ECOG-8200, NCI-6580 and IMCL-0555.

Other Cancers

ImClone, in collaboration with its partners BMS and Merck KGaA, is in the process of supporting an array of Phase I and II evaluations of ERBITUX administered alone or combined with other therapeutic modalities in adult malignancies that express EGFR, including carcinomas of the brain, esophagus, stomach, rectum, cervix, endometrium, ovary, bladder, prostate and breast, as well as pediatric malignancies. The Company and BMS also presented preliminary results from study BMS-045, in which tumor biopsies were performed on approximately 100 patients with refractory colorectal cancer prior to treatment with ERBITUX to ascertain biomarker and/or pharmacogenomic predictors of drug activity.

Human Monoclonal EGFR Inhibitor

ImClone developed a human monoclonal antibody, IMC-11F8, which targets the human EFGR. IMC-11F8 is a high affinity antibody that blocks ligand-dependent activation of the EGFR. Pre-clinical in vitro studies have shown that IMC-11F8 inhibits EGFR activation, downstream signaling pathways and growth of human tumor cells an in vitro it has been shown to be a mediator of antibody-dependent cellular cytotoxicity (ADCC). In pre-clinical human tumor xenograft models, IMC-11F8 suppresses the growth of EGFR-positive tumors and enhances the activity of chemotherapeutic drugs when used in combination. The Company received approval to begin Phase I clinical trials of IMC-11F8 from the National Institute for Public Health and the Environment (RIVM), the Dutch regulatory agency.

Monoclonal Antibody Inhibitors of Angiogenesis

A study, evaluating Phase I endpoints of IMC-1121B administered every 2-weeks, was initiated during the year ended December 31, 2006. As a single agent, 1121B treatment has been associated with tumor regression in several patients with refractory advanced cancer, whereas toxicity has not been preclusive. In addition to overt tumor regression, stable disease exceeding six months has been observed in a notable proportion of patients with refractory solid tumors. Preliminary pharmacokinetic studies indicate that biologically-relevant concentrations are achieved and persist for at least 2 weeks following treatment. One of these ongoing studies has been amended to explore Phase I endpoints of 1121B on an every 3-week schedule, as well.

In August 2007, the Company announced the first disease-directed clinical trials of IMC-1121B has commenced patient enrollment. This Phase II single-arm, multicenter study will evaluate the efficacy, safety and pharmacology of IMC-1121B administered every two weeks to patients with metastatic renal cell carcinoma whose disease has progressed during therapy with an approved VEGFR-2 tyrosine kinase inhibitor or who have developed intolerance to these agents. A second randomized Phase II study of IMC-1121B administered alone or in combination with dacarb

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0

 (IMCL)

Avatar MattCraig (95.17) Submitted: 5/12/08 11:35 AM : Outperform Start Price: $42.72 IMCL Score: -4.53

one of two Ball Belle's come ASCO

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 (IMCL)

Avatar evillate (83.43) Submitted: 5/01/08 6:44 PM : Outperform Start Price: $48.18 IMCL Score: -14.42

Competitors drug showed that it did not help. I'll ride that for a little while.

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 (IMCL)

Avatar Cosmo21 (39.28) Submitted: 4/21/08 8:46 PM : Outperform Start Price: $48.72 IMCL Score: -17.70

Good news!

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Player NamePlayer RatingStart
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TrackCitigroup 89.10 03/19/08 Outperform NS $44.81-6.90%+6.35%-13.25
TrackCowenandCo 65.27 02/22/08 Outperform NS $40.90+2.00%+5.70%-3.69
TrackSoros 57.76 09/30/07 Outperform NS $41.34+0.92%-6.50%+7.42 Toggle the visibility of 60-Second Pitch and replies
TrackBearStearns 93.23 09/11/07 Outperform NS $45.89-9.09%-2.55%-6.54
TrackPiperJaff 68.94 09/05/07 Outperform NS $34.76+20.02%-3.74%+23.76
TrackStanfordRes < 20 08/01/07 Outperform NS $32.66+27.74%-1.79%+29.53
TrackRodmanRen < 20 04/04/07 Outperform NS $42.12-0.95%-0.78%-0.17
TrackJanney < 20 03/23/07 Outperform NS $37.80+10.37%-0.62%+10.99
TrackHSBC 92.88 03/23/07 Outperform NS $38.91+7.22%-0.43%+7.65
TrackJimCramer 80.65 11/06/06 Underperform 3W $31.17+33.85%+2.76%-31.08

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