Erbitux

Icahn and Cornelius trade notes, barbs

Maureen Martino — Fri, 12 Sep 2008 12:47:26 -0400

Bristol-Myers Squibb CEO Jim Cornelius (photo) and ImClone Chairman Carl Icahn were in a letter-writing mood yesterday. In his second of two notes to Icahn, Cornelius expressed his disappointment that ImClone rejected BMS's offer "without discussing its merits with us and our advisors." He also laid claim to Erbitux's successor, IMC-11F8. "Bristol-Myers holds the exclusive, long-term marketing rights in the United States to Erbitux and related compounds, including IMC-11F8. Bristol-Myers has no intention of agreeing to any modifications to these rights," Cornelius asserted. He's clearly unhappy with Icahn's talk of possibly restructuring ImClone, which would separate it's Erbitux business from other drugs in development.

Icahn, never one to stay silent, responded with his own letter late yesterday: "I received today's letter from Bristol and don't understand your point," replied Icahn. ImClone's Chairman complained that BMS made the offer without alerting ImClone of its plans, and that Icahn tried to reach Cornelius before it made its rejection of the bid public. Icahn summarily rejected Cornelius' claim that BMS has exclusive rights to IMC-11F8, stating that BMS's rights to the drug aren't clear. "With respect to a potential restructuring of ImClone, rest assured that we will act in what we consider the best interests of all our shareholders and not just Bristol," finished Icahn.

- check out Cornelius's letter
- read Icahn's response

ImClone builds case for higher takeover bid

John Carroll — Thu, 28 Aug 2008 11:40:44 -0400

The executives at ImClone have been carefully crunching the numbers for both its pipeline drugs as well as Erbitux as it builds a case that Bristol-Myers Squibb's current offer is far too low to accept. Sources tell the Financial Times that the company could fetch $70 a share and that Erbitux alone may well be worth about $60 a share.

Much of the analysis is centered on ImClone's pipeline: five main cancer therapies in Phase I and II. The company has been particularly bullish about the prospects of IMC-A12 for prostate cancer. ImClone has been considering splitting up its R&D programs from Erbitux as a possible alternative to a takeover.

"I would say we thought [the company] was worth $70 plus or minus," an industry source familiar with ImClone told the Financial Times, adding that he still felt the pipeline and infrastructure was "pretty interesting."

- read the article from the Financial Times

SPOTLIGHT: Avastin leaves ASCO ahead of Erbitux

Tue, 03 Jun 2008 06:59:53 -0400

Shares of Genentech have been buoyed by news from ASCO that Avastin will likely be preferred to Erbitux for treating lung cancer. Avastin offers an extra month of average survival time compared to Erbitux. Report

Genetic mutation will narrow target cancer groups

Mon, 02 Jun 2008 06:59:55 -0400

The K-ras gene is coming in for some star treatment at the ASCO meeting in Chicago. The gene plays a key role in several cancers, and new research indicates that the common genetic mutation makes Erbitux useless for slightly more than a third of all patients who may currently qualify for the drug.

The Wall Street Journal notes that the genetic signpost is helping R&D teams design clinical trials for new cancer drugs, using the genetic information to help them identify patients most likely to respond. The developers will benefit by increasing their shot at producing statistically significant data but will likely have to scale back the potential size of their market--a trade-off that payers in the U.S. will be glad to see.

- read the article in the Wall Street Journal

ALSO NOTED: Brandt to helm Noven; Cougar launches Phase III; Wyeth cuts 1,200 jobs; and much more...

Tue, 29 Apr 2008 06:59:50 -0400

> Peter Brandt, a senior VP at Pfizer, has been tapped as the new CEO at Noven Pharmaceuticals. Release

> Cougar Biotechnology has started enrolling patients in its Phase III clinical trial of the company's lead drug candidate, CB7630. Release

> And the ax is falling again. Wyeth notified employees last Friday than another 1,200 jobs will be slashed from the payroll. Wyeth report

> Alexza Pharmaceuticals announced positive results from a Phase I clinical trial of AZ-007, an inhalation product candidate for insomnia. Release

> Pfizer is back at the negotiating table with the Nigerian state of Kano in an attempt to finally settle claims about a meningitis drug trial the government contends was conducted illegally. Pfizer report

> Wanted: CEO who can find a new "cash cow" to push a Danish drugmaker past impending patent expirations. Found: Ulf Wiinberg, lately of Wyeth, to take over Lundbeck. CEO report

> Call it a new pricing strategy. Bristol-Myers Squibb is preparing to launch the cancer treatment Erbitux in Canada after a two-year wrangle over cost. Erbitux report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

And Finally... Australian scientists say that targeting angiotensin converting enzyme (ACE) can be an effective way to spur weight loss and prevent diabetes. ACE inhibitor report

Avastin, Erbitux battle for lung cancer market

Mon, 21 Apr 2008 06:59:54 -0400

Genentech's stock was down this morning on results from a Phase III study of Avastin for non-small cell lung cancer. While the drug did meet the primary endpoint--an improvement in progression-free survival--it missed the secondary endpoint of prolonging overall survival.

Meanwhile, ImClone and European partner Merck KGaA are getting ready to announce results from a trial of Erbitux that shows the drug succeeded where Avastin did not. Erbitux successfully prolonged survival in lung cancer patients, but the specifics are being kept under wraps until the annual ASCO meeting in June. TheStreet observes that while the Avastin results won't cause doctors to stop using the drug, they may back off on the higher doses, which could shrink Genentech's revenue.

- see this release on the trial
- read TheStreet report for more on Erbitux

Related Articles:
Erbitux clears late-stage hurdle for lung cancer. Erbitux report
FDA approves Avastin for lung cancer. Avastin report

MAbs are hottest segment of biotech industry

Fri, 12 Oct 2007 06:59:57 -0400

Looking for the hottest segment of the biotech industry? Then take a look at monoclonal antibodies (mAbs). A new Datamonitor report projects 14 percent annual growth in the market for the antibody drugs, which mimic the body's own immune system. That's by far the fastest-growing segment of the industry. MAbs currently generate global revenues of around $20 billion and include such blockbusters as Avastin, Herceptin, Remicade, Rituxan, Humira and Erbitux.

A major revolution in the mAb market came when drug developers moved away from murine (mouse) antibodies to partially or fully humanized antibodies, which are safer and more effective and allowed mAbs to gain wider usage among patients. And many current mAb therapies are effective for a large number of diseases, making them even more attractive to drug developers.

- check out the Datamonitor report for more

Related Articles:
FDA approves Rituxan for rheumatoid arthritis. Report
FDA approves Avastin for lung cancer. Report
Remicade approved for psoriatic arthritis. Report
FDA approves expanded use of Humira. Report
Erbitux clears late-stage hurdle for lung cancer. Report

SPOTLIGHT: Erbitux ok'd as front-line colon cancer drug

Wed, 03 Oct 2007 06:59:53 -0400

The FDA has approved an Erbitux label update to include additional survival data. ImClone and Bristol-Myers Squibb, who make the drug, announced back in January that research indicated Erbitux proved effective as a front-line therapy against colon cancer. Release

More great investment timing by an ImClone CEO

Thu, 13 Sep 2007 06:59:56 -0400

Talk about great timing: new ImClone CEO John Johnson (formerly, yes, of Johnson & Johnson) did his executive duty Friday by buying a half-million shares of the company's stock at $36.74 each. Monday, the stock closed at $37.93. Yesterday, of course, the stock soared to almost $45, on news that ImClone's cancer drug showed promise in treating lung cancer patients. Shares are currently trading at $44.62.

Johnson's contract with ImClone required him to buy the 500,000 shares within three months of his August 27 start date. And he has to hold the shares for as long as he's CEO. The company says the timing of his stock purchase was a coincidence; he'd come into some money from J&J and decided to go ahead. But with ImClone's history--former CEO Sam Waskal is in prison for insider tip-offs--it may be a coincidence that attracts SEC scrutiny.

- read the report from Mike Huckman's blog on CNBC.com

Related Articles:
ImClone names new CEO. Report
Icahn takes control of ImClone as CEO departs. Report
Investors cheer positive Erbitux trial. Report
ImClone CEO Lynch resigns. Report

Erbitux clears late-stage hurdle for lung cancer

Tue, 11 Sep 2007 06:59:57 -0400

ImClone once again is feeling the tonic effects of positive trial data. Its stock price took off this morning, rising 19 percent after its European partner, Merck KGaA, reported that Erbitux helped increase the survival rate of lung cancer patients. The data may help clear the way to a new approval with blockbuster potential. The trial volunteers were diagnosed with advanced non-small cell lung cancer and divided into two groups that received either a combination of Erbitux and chemotherapy or chemotherapy alone. Last July Erbitux failed a separate late-stage study as a treatment for lung cancer.

Good news for ImClone and its U.S. partner, Bristol-Myers, was bad news for Genentech, which saw its share price clip on the news of a potential competitor.

- see ImClone's release on the trial
- read the AP report

ALSO: Repligen says that ImClone has agreed to pay $65 million to settle patent infringement charges related to Erbitux. Release

Related Articles:
ImClone names new CEO. Report
ImClone shares dive after Erbitux fails a Phase III. Report
Erbitux data underscores leaked disappointment. Report
ImClone buoyed by new Erbitux data. Report
ImClone touts survival rate in Erbitux cancer trial. Report

Abigail Alliance v. Von Eschenbach: A closer look

Fri, 10 Aug 2007 06:59:59 -0400

Abigail Alliance v. Von Eschenbach: A closer look

In 2003, the Abigail Alliance for Better Access to Developmental Drugs sued the FDA to gain greater access to unapproved drugs. The Alliance was founded by Frank Burroughs, the father of Abigail Burroughs, a young woman who was diagnosed with squamous cell carcinoma of the head and neck. After conventional therapies failed, she campaigned hard for access to experimental drugs. However, she did not meet entry criteria for clinical trials of two (then) unapproved cancer therapies--ImClone's Erbitux and AstraZeneca's Iressa. Abigail eventually died while waiting for newer treatment. Erbitux was later approved for head and neck cancer and Iressa for lung cancer.

Currently, the FDA allows limited "compassionate use" of experimental therapies. Patients who don't meet study entry criteria but have no other treatment options may be eligible receive unapproved drugs that have completed Phase II or III trials. But the Abigail Alliance wants patients to have access to therapies after Phase I trials are completed. In its suit, the Alliance argued that after a drug passes Phase I, they are sufficiently safe for expanded human use and should be available to terminally ill patients.

To dying patients, unapproved drugs must look like a treasure trove of possible cures and one can certainly understand their willingness to try any new therapy. But by their very nature, Phase I trials are small and are designed to expose as few people as possible to untested therapeutics to minimize risks. We often see promising drugs go up in flames because of toxicity or efficacy concerns, and early-stage drugs (especially cancer therapies), which haven't survived the rigors of later testing, are more likely to be ineffective and even deadly. Only one in five drug candidates that enter clinical trials will receive FDA approval; most will be abandon because of safety or efficacy problems. Without Phase II and III clinical trials, there is a very real risk that a drug will do more harm than good.

But the Alliance argued that dying patients have a constitutional right to self-defense, which extends to choosing what risks they're willing to face to extend their lives. Should a terminal patient have the right to take a drug that may worsen their condition or even speed up their death? The court ruled that the constitutional right to self-defense doesn't include assuming any and all risk. "Recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process," ruled the majority in the decision.

Aside from safety and efficacy, there are a number of other reasons why expanded access is problematic:

Investigational drugs are extremely expensive to produce and supplies are generally limited.
Finding a physician willing to administer an inadequately tested drug would be difficult at best given the potential liabilities.
Expanded access would erode the FDA's authority. There would be loss of control over the actual access to prescription drugs, and untested therapies could be provided to patients outside of clinical trials which the FDA has not approved.
Perhaps most importantly, if patients can get new drugs before clinical trials are completed, it would seriously undermine the entire clinical trial process because patients would have no reason to enroll in trials. If the drug is available outside of a clinical trial, the rigorous scientific controls over the data normally collected during the conduct of a study would be lost. This would slow the approval process to the detriment of the general public.

The FDA is under pressure from critics who say it allows unsafe drugs on the market. But patient advocates castigate the agency for taking too long to get new therapies to the public. Both arguments are valid, and it's essential that the FDA find the delicate balance between the two. The Abigail Alliance plans to appeal the case to the Supreme Court. - Maureen Martino

ImClone names new CEO

Fri, 10 Aug 2007 06:59:56 -0400

ImClone, the maker of Erbitux, has named John H. Johnson its CEO, effective August 27, 2007. Johnson was previously Johnson & Johnson's Company Group Chairman of Worldwide Biopharmaceuticals. The top spot at ImClone has been vacant since billionaire investor Carl Icahn took the helm as the former CEO Joseph Fischer bowed out. ImClone's only approved drug--Erbitux--recently flunked a Phase III lung cancer trial and faces competition from other cancer drugs.

- see this press release for more

Related Articles:
Icahn takes control of ImClone as CEO departs. Report
ImClone shares dive after Erbitux fails a Phase III. Report

ImClone shares dive after Erbitux fails a Phase III

Thu, 12 Jul 2007 06:59:55 -0400

ImClone stock dived 8 percent this morning when researchers announced that a late-stage trial of Erbitux as a first-line therapy for advanced lung cancer flunked its primary endpoint of progression-free survival as assessed by an independent radiology review committee. Researchers, though, put the best spin on the data that they could, noting that secondary endpoints--including response rate--"were statistically significant and favored the Erbitux-containing arm."

"We consider lung cancer to be a high priority and await the results of other Phase II and Phase III evaluations of ERBITUX in the first- and second- line setting with chemotherapy regimens," said ImClone medical chief Eric K. Rowinsky.

- for more on the data, see the release
- read TheStreet.com report on ImClone

Related Articles:
Erbitux data underscores leaked disappointment. Report
ImClone buoyed by new Erbitux data. Report
Erbitux data could gin extra $350M in sales. Report
Analysts raise doubts on Erbitux ruling. Report
ImClone touts survival rate in Erbitux cancer trial. Report

ALSO NOTED: ReNeuron confident of trial OK; Valeant licenses Xyrem rights;and much more...

Thu, 11 Jan 2007 19:01:30 -0500

> ReNeuron Group says it is confident that it can gain regulatory approval to start a Phase I stem cell trial of ReN001 after the FDA put a hold on the study on Tuesday. Report

> Valeant Pharmaceuticals has licensed the Canadian rights to Jazz's cataplexy treatment Xyrem. Report

> A group of buyout firms including Texas Pacific have set their sights on a potential offer for Merck KGaA's generic drug unit. Report

> Chelsea Therapeutics is touting the outcome of a European Phase IIb trial of Droxidopa for neurogenic orthostatic hypotension. Release

And Finally… ASCO has touted the development of more targeted cancer therapies as well as a newly approved cervical cancer vaccine as the top advancements in the field for 2006. Sutent, Tykerb, Sprycel and Erbitux have all been held up as examples of effective, targeted cancer drugs. Article

Press Release: Erbitux Phase III Study Meets Primary Endpoint In First-Line Treatment Of Metastatic Colorectal Cancer

Maureen Martino — Wed, 10 Jan 2007 10:45:27 -0500

ImClone Systems Incorporated And Bristol-Myers Squibb Company Release: ERBITUX Phase III Study Meets Primary Endpoint In First-Line Treatment Of Metastatic Colorectal Cancer

NEW YORK, Jan. 10 -- ImClone Systems Incorporated and Bristol-Myers Squibb Company today announced that a Phase III study of ERBITUX (cetuximab) plus FOLFIRI (an irinotecan- based chemotherapy) met the primary endpoint of increasing median duration of progression-free survival over FOLFIRI alone in patients with previously untreated metastatic colorectal cancer (mCRC). More than 1,000 patients were recruited from around the world to participate in the study, known as the CRYSTAL(1) study.

"Despite advancements, metastatic disease remains difficult to treat. This study demonstrates the potential benefit of adding ERBITUX to first-line treatment of metastatic colorectal cancer," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

"These results provide important new information for patients with metastatic colorectal cancer, and are part of a comprehensive clinical development program designed to fully understand the potential uses of ERBITUX for cancer patients," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb.

The study was conducted by Merck KGaA, Darmstadt, Germany, ImClone Systems' ERBITUX partner outside of North America. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.

About ERBITUX® (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. While the mechanism of ERBITUX' anti-tumor effect(s) in vivo is unknown, all of these processes may contribute to the overall therapeutic effect of ERBITUX. EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

ERBITUX (Cetuximab), in combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy. The effectiveness of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX for the treatment of EGFR-expressing mCRC.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit http://www.ERBITUX.com.

Important Safety Information

Grade 3/4 infusion reactions, rarely with fatal outcome, occurred in approximately 3% (46/1485) of patients receiving ERBITUX (Cetuximab) therapy. These reactions are characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, hypotension, and/or cardiac arrest. Severe infusion reactions require immediate and permanent discontinuation of ERBITUX therapy.

Most reactions (90%) were associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines. Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. A 1-hour observation period is recommended following the ERBITUX infusion. Longer observation periods may be required in patients who experience infusion reactions.

Cardiopulmonary arrest and/or sudden death occurred in 2% (4/208) of patients with squamous cell carcinoma of the head and neck treated with radiation therapy and ERBITUX as compared to none of 212 patients treated with radiation therapy alone. Fatal events occurred within 1 to 43 days after the last ERBITUX treatment. ERBITUX in combination with radiation therapy should be used with caution in patients with known coronary artery disease, congestive heart failure and arrhythmias. Close monitoring of serum electrolytes, including serum magnesium, potassium, and calcium during and after ERBITUX therapy is recommended.

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of 774 patients with advanced colorectal cancer (mCRC) receiving ERBITUX. There was one case of ILD reported in 796 patients with head and neck cancer receiving ERBITUX in clinical studies.

In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, and inflammatory and infectious sequelae (eg, blepharitis, cheilitis, cellulitis, cyst) were reported. In 208 patients receiving ERBITUX + RT, acneform rash was reported in 87% (17% severe) as compared to 10% in 212 patients treated with radiation therapy alone (1% severe). In patients receiving ERBITUX alone, 76% (N=103) experienced acneform rash (1% severe). In patients with mCRC, acneform rash was reported in 89% (686/774) of all treated patients, and was severe in 11% (84/774). Subsequent to the development of severe dermatologic toxicities, complications including S. aureus sepsis and abscesses requiring incision and drainage were reported. Sun exposure may exacerbate these effects. A related nail disorder, occurring in 12% (0.4% Grade 3) of patients, was characterized as a paronychial inflammation.

The safety of ERBITUX in combination with radiation therapy and cisplatin has not been established. Death and serious cardiotoxicity were observed in a single-am trial with ERBITUX, delayed, accelerated (concomitant boost) fractionation radiation therapy, and cisplatin (100 mg/m2) conducted in patients with locally advanced squamous cell carcinoma of the head and neck. Two of 21 patients died, one as a result of pneumonia and one of an unknown cause. Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events (myocardial infarction in one patient and arrhythmia, diminished cardiac output, and hypotension in the other patient).

The incidence of hypomagnesemia (both overall and severe [NCI CTC Grades 3 & 4]) was increased in patients receiving ERBITUX alone or in combination with chemotherapy as compared to those receiving best supportive care or chemotherapy alone based on ongoing, controlled clinical trials in 244 patients. Approximately one-half of these patients receiving ERBITUX experienced hypomagnesemia and 10-15% experienced severe hypomagnesemia. Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required. Patients receiving ERBITUX therapy should be periodically monitored for hypomagnesemia, and accompanying hypocalcemia and hypokalemia during, and up to 8 weeks following the completion of, ERBITUX therapy.

The most serious adverse reactions associated with ERBITUX in combination with radiation therapy in 208 patients with head and neck cancer were infusion reaction (3%), cardiopulmonary arrest (2%), dermatologic toxicity (2.5%), mucositis (6%), radiation dermatitis (3%), confusion (2%), and diarrhea (2%).

The most serious adverse reactions associated with ERBITUX in mCRC clinical trials (N=774) were infusion reaction (3%), dermatologic toxicity (1%), interstitial lung disease (0.4%), fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX with irinotecan, 2% in patients receiving ERBITUX as a single agent) and diarrhea (6% in patients receiving ERBITUX with irinotecan, 0.2% in patients receiving ERBITUX as a single agent).

The overall incidence of late radiation toxicities (any grade) was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone. The following sites were affected: salivary glands (65%/56%), larynx (52%/36%), subcutaneous tissue (49%/45%), mucous membranes (48%/39%), esophagus (44%/35%), skin (42%/33%), brain (11%/9%), lung (11%/8%), spinal cord (4%/3%), and bone (4%/5%) in the ERBITUX and radiation versus radiation alone arms, respectively.

The incidence of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the ERBITUX plus radiation therapy arms.

The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX in combination with radiation therapy (n=208) versus radiation alone (n=212) were mucositis-stomatitis (93%/94%), acneform rash (87%/10%), radiation dermatitis (86%/90%), weight loss (84%/72%), xerostomia (72%/71%), dysphagia (65%/63%), asthenia (56%/49%), nausea (49%/37%), constipation (35%/30%) and vomiting (29%/23%). The most common adverse events seen in patients with carcinomas of the head and neck receiving ERBITUX as a single agent (N=103) were acneform rash (76%), asthenia (45%), pain (28%), fever (27%) and weight loss (27%).

The most common adverse events seen in patients with mCRC receiving ERBITUX with irinotecan (n=354) or ERBITUX as a single agent (n=420) were acneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea (72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting (41%/25%), fever (34%/27%), constipation (30%/26%), and headache (14%/26%).

About Colorectal Cancer

In the U.S., approximately 149,000 people will be diagnosed with cancer of the colon or rectum this year. Half of these patients have metastatic disease, or cancer that has spread to other organs, at the time of diagnosis. EGFR is expressed in up to 77.7% of colorectal cancer tumors. Colorectal cancer is the third most common cancer in both men and women.(2)

About ImClone Systems

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

About Bristol-Myers Squibb

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies designed to extend and enhance the lives of patients living with cancer. More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment. With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today. Hundreds of scientists at Bristol- Myers Squibb's Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2005 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

(1) Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer (2) American Cancer Society: Cancer Facts and Figures 2006. http://www.cancer.org/downloads/STT/CAFF2006PWSecured.pdf. Accessed 5/16/06.

Source: ImClone Systems Incorporated; Bristol-Myers Squibb Company

Erbitux data backs use as front-line therapy

Tue, 09 Jan 2007 19:01:35 -0500

Researchers announced that Erbitux proved effective as a front-line therapy against colon cancer, a big development for a therapy that is currently approved only after the unsuccessful use of chemotherapy. Data indicates that Erbitux delays progression of the disease when given as a combinational therapy with chemotherapy. That's good news for Bristol-Myers Squibb and ImClone, which share the revenue from the drug. Merck KGaA is ImClone's partner outside of the U.S. All three have been threatened by Amgen's Vectibix, which is putting pressure on the price of the drug.

- see the release on the data
- here's the report on Erbitux from CNN

Related Articles:
Analysts raise doubts on Erbitux ruling. Report
Erbitux effective in cancer trial. Report
Icahn takes control of ImClone as CEO departs. Report

Glaxo forges $2.1B deal for HuMax-CD20

Mon, 18 Dec 2006 19:01:38 -0500

Denmark's Genmab will gain up to $2.1 billion in a licensing deal with GlaxoSmithKline for the HuMax-CD20 antibody for leukemia, far outstripping the numbers predicted by analysts. Genmab will get $102 million up front, a 10 percent equity investment worth $357 million and up to $1.6 billion in milestone payments. The therapy is in a late-stage trial for chronic lymphocytic leukemia and non-Hodkin's lymphoma and in mid-stage trials for rheumatoid arthritis and new cases of lymphocytic leukemia. Genmab has forecast that HuMax-CD20 will gain regulatory approval in 2008 and has projected top annual sales of $2 billion. Analysts say that this is the biggest licensing deal on record, surpassing the $2 billion deal for Erbitux which was later scaled down.

GlaxoSmithKline has been on a buying spree recently, inking the acquisition of Domantis while executing a string of licensing deals. Altogether, Glaxo has committed up to $4 billion in the last two weeks to buyouts and development pacts. Glaxo is putting the market on notice that it is bullishly stuffing its pipeline with some of the brightest therapeutic hopes tracked around the globe as it prepares to lose patent control of its blockbusters.

- check out the release for more information
- read the report on the deal from the International Herald Tribune

Related Articles:
Genmab shares up on new antibody tech. Report
Glaxo to buy Domantis for $453M. Report
Epix shares soar on $1.2B pact with GSK. Report

SPOTLIGHT: Erbitux trials produce mixed data

Sun, 05 Nov 2006 19:01:33 -0500

ImClone and Bristol-Myers Squibb report mixed results from two more studies of Erbitux. In one study of Erbitux with Best Supportive Care versus Best Supportive Care alone, the therapy demonstrated an improvement in overall survival. A separate trial comparing irinotecan to irinotecan plus Erbitux failed to demonstrate a statistically significant improvement for the Erbitux group. Report

Icahn takes control of ImClone as CEO departs

Tue, 24 Oct 2006 20:01:38 -0400

The battle for control of ImClone is over. Billionaire investor Carl Icahn took the helm today as embattled CEO Joseph Fischer bowed out. Icahn was named chairman and a close associate was picked to find a new CEO for the world's most notorious biotech company. Also, the final three board members who stood in Icahn's way said they would not stand for reelection, leaving the field wide open for the investor to wield his influence.

Icahn has been a loud and frequent critic of ImClone, saying that its executives had no real clue what they were doing. His first step, he says, will be to examine the relationship of ImClone with Bristol-Myers Squibb, which markets Erbitux. Erbitux now faces competition from a similar therapy developed by Amgen. Icahn also says he will be focused on fixing everything that has gone wrong at ImClone over the last three years. That's no small task.

- here's the MarketWatch report on Icahn

ALSO NOTED: Analysts question J&J copycat; Novartis seeks Rasilez approval in Europe;and much more...

Thu, 28 Sep 2006 20:01:30 -0400

> The Wall Street Journal looks at the case of J&J's schizophrenia drug paliperidone, which the FDA is expected to decide on today. The therapy is a close version of its bestselling Risperdal. Analysts see the new drug, which simply removes the need for the body to metabolize the active ingredient, as a way for the company to extend its control of the therapy by five years. But others see little medical advantage coming from an officially sanctioned copycat drug. Article (WSJ sub. req.)

> Novartis is out to gain European for a new blood pressure therapy developed with Speedel. Researchers are staking their application on the results of a 7,800-member trial that demonstrated Rasilez's ability to lower blood pressure in four weeks. It would be the first new blood pressure therapy in 10 years. Report

> Elan has released new data on Tysabri illustrating that the drug offers a sustained benefit on relapse rates for up to three years. Report

> The Motley Fool offers some incisive analysis on ImClone's recent travails, noting that ImClone's shares actually ended up higher after Amgen announced the FDA's approval of a new competitor for Erbitux that will be priced at a 20 percent discount. Investors, they say, are looking to rebel investor Carl Icahn to shake things up now that he's on the board. Article

> The European Commission has approved Pfizer's anti-smoking therapy Champix. Report

> A.P. Pharma has pushed back its timeline to release data on its experimental therapy to treat the side effects of nausea, citing problems enrolling patients and preparing trial sites. Data is now expected in the second half of 2007 instead of the first quarter. Report

> Minneapolis-based CoAxia announced that it has reached terms with Canaan Venture Partners, Prism Venture Partners, Affinity Capital Management, and Baird Venture Partners on an $11 million Series C round of financing. Release

> Basilea Pharmaceutica's experimental antibiotic Ceftobiprole demonstrated cure rates of up to 92 percent for patients with staphylococcal infections. Report

> GlaxoSmithKline will invest more than €500 million in a new vaccine plant in France. Report

> Wisconsin Governor Jim Doyle is offering free stem cell licenses to firms sponsoring research in the state's non-profit and academic institutions. Report

> TAP Pharmaceutical has signed on to co-promote Novartis' genital herpes drug Famvir. Report

> DOR BioPharma has won two additional grants from the National Institute of Allergy and Infectious Diseases totaling approximately $5.3 million. Release

And Finally… While the FDA is harshly criticized for infighting and poor drug oversight procedures, more and more drug company execs see an agency that has been steadily tightening the reins on new approvals. Article