WVR-V Wind River Energy. Spiked a ton today. Apparently an emerging Niobrara play. Anybody here familar?

HAL represents FTK's cleaning fracking fluids in its product line currently. Thats whats driving the sales turnaround.

9/15/2010 9:35 a.m.

http://www.meetmax.com/sched/event_6089/~public/nh/conference_presentations.html?event_id=6089

Here is something new of significance:

SSN in its presentation at the IPAA conferenc today saying it has 46K net acres in the Niobrara, with one producer. Decent sized acreage there just north of EOG.

This may be the next Bakken.

Horse leaving the barn. 1.63 +.20 or 14%

Gary Evans and team have a reputation. Raising money, even
two times the market cap will not be an issue here.

Agree that this one being discovered. Price action speaks for itself.

Imclone’s Erbitux BMS-099 trial not powered to show overall survival, FLEX remains pivotal registrational trial
By Kimberly Ha in New York

Published: May 15 2008 15:01 | Last updated: May 15 2008 15:01


This article is provided to FT.com readers by Pharmawire—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.pharmawire.com
--------------------------------------------------------------------------------------------------------


Imclone’s Erbitux BMS-099 trial was not powered to show overall survival and expectations for conclusive data remain low, Dr Eric Rowinsky, executive vice president and chief medical officer told Pharmawire.

Erbitux is a monoclonal antibody currently approved to treat head and neck cancer and colon cancer. It is also being tested for use in non-small cell lung cancer (NSCLC), with key trial results expected at the upcoming American Society of Clinical Oncology conference in Chicago. The drug is co-marketed in the U.S. with Bristol-Myers Squibb and Germany’s Merck KgaA.

Although the company will have OS data for the BMS-099 trial in 2H08, ”expectations are low because it really takes a lot of patients to show statistical power.” The trial recruited 660 patients, and previously failed to meet its endpoint of progression free survival (PFS), Rowinsky added.

Furthermore, the FDA does not consider PFS as endpoint in lung cancer trials, and an improvement in PFS will not likely garner approval, he added. The only trial powered for OS is the FLEX trial, but Imclone will include the BMS-099 trial as part of its submission to the FDA.

The FLEX trial is Imclone’s pivotal trial, which measures OS. ”Nothing is short of survival in lung cancer...to be beneficial for patients,” said Rowinsky.

Although the FDA approved Avastin for breast cancer based on a benefit in PFS, a competing industry executive said OS remains the only logical endpoint for approval in lung cancer, given the cost implications of this drug.

Although Genentech’s Avastin has seen bleeding risk in squamous cell patients, Rowinsky said Imclone is not just going after squamous cell patients, but all patients in non-small cell lung cancer (NSCLC). When asked whether a 4-week survival benefit would be enough, physicians interviewed by this news service were disappointed with Erbitux’s modest 6-week survival benefit in metastatic colorectal cancer (mCRC), Rowinsky said ”you’ve got to start somewhere. We don’t have too many drugs right now for lung cancer.”

”If you accept a drug with one-month survival, if the company can do further work and find a KRAS mutation influence, they can make further progress in being able to channel that drug to patients who will better respond,” Rowinsky said.

The competing industry executive said the FDA will consider two things for approval - the overall survival data and the toxicity profile. If the data is very compelling, the agency might not refer Imclone’s submission to the ODAC. He noted that if the data is ambiguous and if the other trials, apart from FLEX, are negative or neutral, the FDA will likely refer it to the ODAC - where a negative trial has more weight.

Similar to the Avastin’s recent approval in breast cancer, even though it was voted down 5-4 by the FDA advisory committee, it was approved. He speculated that the approval was based on subsequent data by Roche which was not disclosed publicly. ”We don’t know the arrows in BMS and Imclone’s quivers. We need to look at the FLEX study. ”It’s a reference trial, and if the data is 4-weeks or higher, it will be blockbuster territory for this drug,” the competing executive said.

However, the only hindrance may be the drug’s toxicity profile, which will be known at the company’s June 1 Plenary Session at the American Society of Clinical Oncology (ASCO). The agency will also consider ”morbidity management,” and not just the overall survival benefit in weeks. There can be several trials that disagree based on the differences in patient selection, the industry executive added.

There is also a subtle difference between the FDA acceptance for an NDA versus sNDA, he said. In a worse case scenario that it is not approved, physicians may opt to use the drug off-label in lung cancer, as it is already on the market for metastatic colorectal cancer (mCRC), the industry executive noted. The FDA may give Erbitux a first-line registration or line extension, based on the data.

If there is a high profile side-effect for Erbitux, that is similar to Avastin’s bleeding risk in squamous patients, this will result in a morbidity problem with added costs for Imclone, the industry executive said. Genentech’s Tarceva, currently approved in second and third-line NSCLC, has seen flat sales due to a side-effect of rash - which is seen in 30% of patients. However, the rash has been taken as an indicator of the drug’s efficacy, and more rash means more binding of the EGFR kinase, he said. All EGFR drugs cause some degree of rash, and Erbitux - being a monoclonal antibody and not a small molecule like Tarceva - may cause even more rash, he noted.

”Erbitux is not without problems. Rash is a big issue for the patients, if it’s second degree or higher,” the competing industry executive said. Dual-inhibition of pathways may also be another problem, as Amgen’s EGFR-inhibitor Vectibix and VEGF-drug Avastin led to faster cancer progression in metastatic colorectal cancer. He added that Vectibix is an inferior product to Erbitux, as the reason relates primarily to the drug’s binding and off-target activity.

It will come down to a function of strong marketing. ”The odds are although Avastin showed bleeding in squamous patients, it will still have the dominant position in lung cancer for awhile,” he said. There will be a steep road uphill for any compound that wants to break into frontline NSCLC. Erbitux will probably focus on squamous cell patients, the industry executive added.

When asked why Imclone did not decide to run a trial with one squamous arm, and one non-squamous arm to see what the exact differences are between these two groups, Rowinsky said it is a ”dangerous” suggestion. He disputed this idea and said Imclone is not looking to make a division between use in squamous and non-squamous patients. FLEX has a primary endpoint of OS for all patients with NSCLC.

There is an unmet medical need because of Avastin’s deficiency in squamous, but ”our trial is not focused on squamous and is powered for all patients,” said Rowinsky. But Imclone will be looking at squamous and non-squamous data histologically to determine in a prospective fashion what the effect is.

The number of squamous patients in the FLEX trial are around 20-30%. However, the trial is not powered for squamous cell patients, ”unless there is a major effect,” said Rowinsky. ”We will be presenting subtype information, but the trial and goals are really [to] get the drug approved.”

Imclone has a current market cap of USD 3.73bn.

Imclone’s Erbitux BMS-099 trial not powered to show overall survival, FLEX remains pivotal registrational trial
By Kimberly Ha in New York

Published: May 15 2008 15:01 | Last updated: May 15 2008 15:01


This article is provided to FT.com readers by Pharmawire—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.pharmawire.com
--------------------------------------------------------------------------------------------------------


Imclone’s Erbitux BMS-099 trial was not powered to show overall survival and expectations for conclusive data remain low, Dr Eric Rowinsky, executive vice president and chief medical officer told Pharmawire.

Erbitux is a monoclonal antibody currently approved to treat head and neck cancer and colon cancer. It is also being tested for use in non-small cell lung cancer (NSCLC), with key trial results expected at the upcoming American Society of Clinical Oncology conference in Chicago. The drug is co-marketed in the U.S. with Bristol-Myers Squibb and Germany’s Merck KgaA.

Although the company will have OS data for the BMS-099 trial in 2H08, ”expectations are low because it really takes a lot of patients to show statistical power.” The trial recruited 660 patients, and previously failed to meet its endpoint of progression free survival (PFS), Rowinsky added.

Furthermore, the FDA does not consider PFS as endpoint in lung cancer trials, and an improvement in PFS will not likely garner approval, he added. The only trial powered for OS is the FLEX trial, but Imclone will include the BMS-099 trial as part of its submission to the FDA.

The FLEX trial is Imclone’s pivotal trial, which measures OS. ”Nothing is short of survival in lung cancer...to be beneficial for patients,” said Rowinsky.

Although the FDA approved Avastin for breast cancer based on a benefit in PFS, a competing industry executive said OS remains the only logical endpoint for approval in lung cancer, given the cost implications of this drug.

Although Genentech’s Avastin has seen bleeding risk in squamous cell patients, Rowinsky said Imclone is not just going after squamous cell patients, but all patients in non-small cell lung cancer (NSCLC). When asked whether a 4-week survival benefit would be enough, physicians interviewed by this news service were disappointed with Erbitux’s modest 6-week survival benefit in metastatic colorectal cancer (mCRC), Rowinsky said ”you’ve got to start somewhere. We don’t have too many drugs right now for lung cancer.”

”If you accept a drug with one-month survival, if the company can do further work and find a KRAS mutation influence, they can make further progress in being able to channel that drug to patients who will better respond,” Rowinsky said.

The competing industry executive said the FDA will consider two things for approval - the overall survival data and the toxicity profile. If the data is very compelling, the agency might not refer Imclone’s submission to the ODAC. He noted that if the data is ambiguous and if the other trials, apart from FLEX, are negative or neutral, the FDA will likely refer it to the ODAC - where a negative trial has more weight.

Similar to the Avastin’s recent approval in breast cancer, even though it was voted down 5-4 by the FDA advisory committee, it was approved. He speculated that the approval was based on subsequent data by Roche which was not disclosed publicly. ”We don’t know the arrows in BMS and Imclone’s quivers. We need to look at the FLEX study. ”It’s a reference trial, and if the data is 4-weeks or higher, it will be blockbuster territory for this drug,” the competing executive said.

However, the only hindrance may be the drug’s toxicity profile, which will be known at the company’s June 1 Plenary Session at the American Society of Clinical Oncology (ASCO). The agency will also consider ”morbidity management,” and not just the overall survival benefit in weeks. There can be several trials that disagree based on the differences in patient selection, the industry executive added.

There is also a subtle difference between the FDA acceptance for an NDA versus sNDA, he said. In a worse case scenario that it is not approved, physicians may opt to use the drug off-label in lung cancer, as it is already on the market for metastatic colorectal cancer (mCRC), the industry executive noted. The FDA may give Erbitux a first-line registration or line extension, based on the data.

If there is a high profile side-effect for Erbitux, that is similar to Avastin’s bleeding risk in squamous patients, this will result in a morbidity problem with added costs for Imclone, the industry executive said. Genentech’s Tarceva, currently approved in second and third-line NSCLC, has seen flat sales due to a side-effect of rash - which is seen in 30% of patients. However, the rash has been taken as an indicator of the drug’s efficacy, and more rash means more binding of the EGFR kinase, he said. All EGFR drugs cause some degree of rash, and Erbitux - being a monoclonal antibody and not a small molecule like Tarceva - may cause even more rash, he noted.

”Erbitux is not without problems. Rash is a big issue for the patients, if it’s second degree or higher,” the competing industry executive said. Dual-inhibition of pathways may also be another problem, as Amgen’s EGFR-inhibitor Vectibix and VEGF-drug Avastin led to faster cancer progression in metastatic colorectal cancer. He added that Vectibix is an inferior product to Erbitux, as the reason relates primarily to the drug’s binding and off-target activity.

It will come down to a function of strong marketing. ”The odds are although Avastin showed bleeding in squamous patients, it will still have the dominant position in lung cancer for awhile,” he said. There will be a steep road uphill for any compound that wants to break into frontline NSCLC. Erbitux will probably focus on squamous cell patients, the industry executive added.

When asked why Imclone did not decide to run a trial with one squamous arm, and one non-squamous arm to see what the exact differences are between these two groups, Rowinsky said it is a ”dangerous” suggestion. He disputed this idea and said Imclone is not looking to make a division between use in squamous and non-squamous patients. FLEX has a primary endpoint of OS for all patients with NSCLC.

There is an unmet medical need because of Avastin’s deficiency in squamous, but ”our trial is not focused on squamous and is powered for all patients,” said Rowinsky. But Imclone will be looking at squamous and non-squamous data histologically to determine in a prospective fashion what the effect is.

The number of squamous patients in the FLEX trial are around 20-30%. However, the trial is not powered for squamous cell patients, ”unless there is a major effect,” said Rowinsky. ”We will be presenting subtype information, but the trial and goals are really [to] get the drug approved.”

Imclone has a current market cap of USD 3.73bn.

ELN & WYE

This ought be of interest to WYE and by way of extension ELN shareholders. ELN may have one less partner with competive and conflicted interests as occured with BIIB and Avonex.

Wyeth-WYE study evaluating ACC-001 suspended
WYE: [theflyonthewall] - 04-17 11:00 AM
[Reference Link]:[http://www.clinicaltrials.gov/ct2/show/NCT00498602?term=acc-001&rank=2]

Stevie is the biggest HF on the street and a fast trading machine. He may gone by the time you read this...or not. But in either case it will certainly draw some attention.

Analysis of July IMS Sales Data
Tracking IMS Monthly Sales Data
 What's New? Today, IMS released pharmaceutical hospital sales data for July.
 Amgen’s Epogen/Aranesp: Epogen sales were $236M, tracking at $621M vs. our
$622M U.S. estimate. Aranesp sales are tracking at $517M vs. our U.S. estimate
of $534M.
 Amgen’s Neupogen Tracking In-Line — Neupogen sales are tracking at $216M vs.
our $202M U.S. estimate, while Neulasta is tracking at $684M vs. our $602M U.S.
estimate.
 Amgen’s Vectibix: Amgen’s Vectibix IMS reported sales of $13M suggest quarterly
sales of $43M vs. our U.S. estimate of $44M.
 ImClone’s Erbitux: ImClone’s Erbitux sales were $56M. Erbitux sales are tracking at
approx. $178M in the second quarter vs. our $172M U.S. estimate.
 Celgene’s Thalomid: IMS reported Thalomid sales in July of $32M. Thalomid is
tracking at $118M vs. our Q3:07 U.S. estimate of $112M.
 Millennium’s Velcade: IMS reported Velcade sales in July of $22M. Velcade is
tracking at $67M vs. our Q3:07U.S. estimate of $66M.
 Pharmion’s Vidaza posted sales of $11M. Vidaza sales are currently tracking at
$33M vs. our Q3:07 U.S. estimate of $33M.
 Amylin’s Byetta posted sales of $48M. Byetta sales are currently tracking at $164M
vs. our Q3:07 U.S. estimate of $167M.
 The Medicines Company's Angiomax posted sales of $19M. Angiomax sales are
currently tracking at $60M vs. our Q3:07 U.S. estimate of $62M.
Yaron Werber, MD
+1-212-816-8836
yaron.werber@citigroup.com
Kinam Hong, MD CFA
kinam.hong@citigroup.com
See Appendix A-1 for Analyst Certification and important disclosures.

Phase II Study of IMC-A12 for Advanced Colorectal Cancer Has Commenced Patient Enrollment
By Business Wire
Last Updated: 07/12 05:35PM

NEW YORK--ImClone Systems Incorporated (NASDAQ: IMCL) today announced that the first of its Phase II clinical trials of the anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody IMC-A12 has commenced patient enrollment.


A randomized Phase II study of IMC-A12 as a single agent or in combination with cetuximab, in patients with metastatic colorectal cancer with disease progression demonstrated during prior treatment with cetuximab, has begun to enroll patients. A total of 40 to 72 patients are expected to be enrolled. Based on supportive preclinical data indicating highly favorable anticancer interactions when IMC-A12 and cetuximab are combined, this Phase II study is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion as a single agent and in combination with cetuximab.


"This first disease-directed study of IMC-A12 in combination with cetuximab paves the way for a wide range of activity finding studies, many of which will begin over the next several months in various rational tumor types," said Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.


IMC-A12 is a fully human IgG1Mab that is designed to specifically target the human insulin-like growth factor type 1 receptor, thereby inhibiting certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival.


About ImClone Systems

Phase II Study of IMC-A12 for Advanced Colorectal Cancer Has Commenced Patient Enrollment
By Business Wire
Last Updated: 07/12 05:35PM

NEW YORK--ImClone Systems Incorporated (NASDAQ: IMCL) today announced that the first of its Phase II clinical trials of the anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody IMC-A12 has commenced patient enrollment.


A randomized Phase II study of IMC-A12 as a single agent or in combination with cetuximab, in patients with metastatic colorectal cancer with disease progression demonstrated during prior treatment with cetuximab, has begun to enroll patients. A total of 40 to 72 patients are expected to be enrolled. Based on supportive preclinical data indicating highly favorable anticancer interactions when IMC-A12 and cetuximab are combined, this Phase II study is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion as a single agent and in combination with cetuximab.


"This first disease-directed study of IMC-A12 in combination with cetuximab paves the way for a wide range of activity finding studies, many of which will begin over the next several months in various rational tumor types," said Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.


IMC-A12 is a fully human IgG1Mab that is designed to specifically target the human insulin-like growth factor type 1 receptor, thereby inhibiting certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival.


About ImClone Systems

YMI: Opinions on the HR's in this release today? In short, can this be a significant drug?

Ym Biosciences Announces Secondary Efficacy and Safety Findings in Randomized Phase Iib Aerolef(TM) Trial
Wednesday July 11, 7:00 am ET
- Company Announces Lead Investigator for U.S. Trial -

MISSISSAUGA, ON, July 11 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX: YMI, TSX: YM, AIM: YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced results of secondary endpoint data from its 99 patient, randomized, placebo-controlled, multi-center Phase IIb trial (DLXLEF-AP4) with AeroLEF(TM). AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. YM previously announced that this trial had successfully achieved its primary endpoint, the summed pain intensity difference/pain relief scores (SPRID4) during the 4 hours from the start of the initial dose of study medication (p=0.0194).

Additional Secondary Efficacy and Safety Findings

The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when patients reported a pain intensity score (PI) of at least 2 (moderate pain) on a 4-point verbal rating scale (0 (none) to 3 (severe pain)). The clinical trial study period was up to 12 hours and patients were allowed to self-administer AeroLEF(TM) to treat up to two additional pain episodes during the study period. For each pain episode, patients were instructed to continue the self-administration of drug until achievement of one of the following endpoints: achievement of effective analgesia, completion of full dose, or onset of dose-limiting side effects. Patients were allowed rescue medication at any time following initiation of study treatment.

For the first dose administered in the PACU, the percentage of patients reporting a pain intensity (PI) score of less than or equal to 1 (mild pain or no pain) at the end of the dosing period with AeroLEF(TM) was 59%, a statistically significant difference from placebo (27%) (p=0.005). As well, the percentage of patients reporting a pain relief (PR) score of more than or equal to 2 (moderate, lots or complete relief) at the end of the dosing period with AeroLEF(TM) was 60%, also statistically significant compared to placebo (32%) (p=0.0166).

Both the TOTPAR4 (total pain relief over 4 hours, summed pain relief scores) and SPID4 (summed pain intensity difference scores patients report over first 4 hours after initiation of dosing) values for the first dose of AeroLEF(TM) showed statistically significant differences over placebo (p<0.02), consistent with the outcome of the primary endpoint. Across the entire study, for up to three dosing sessions with AeroLEF(TM), self-declared effective analgesia occurred within six minutes in 25% of patients, within 11 minutes in 50%, and within 20 minutes in 75%. Patients receiving AeroLEF(TM) in the blinded portion of the trial reported a mean duration of effective pain relief time of 237 minutes (~4 hours) for the first dose. Similar means were observed across subsequent doses of AeroLEF(TM); 229.2 minutes and 243.5 minutes for doses two and three, respectively.

Administration of AeroLEF(TM) in this study resulted in no unexpected adverse safety events. Attributable adverse events (AEs) observed were generally consistent with typical opioid adverse effects seen in the immediate post-operative period. Treatment-emergent AEs were similar between treatment groups: 70.8% in the AeroLEF(TM) group compared with 67.6% in the placebo group. The majority of adverse events were mild in intensity. Opioid antagonists (interventional medication commonly necessary in studies of opioids) were not administered to any subjects in the trial. AeroLEF does not appear to increase the risk of key adverse events (such as hypoxia and bradypnea) and has the potential to minimize certain otherwise expected adverse effects of interest to patients and physicians, warranting further investigation and development.

"These results, from this difficult to treat patient population, confirm that patients are able to personally select doses of opioids to match the quantity of relief to the intensity of each pain event while maintaining a favorable safety tolerability profile," said Diana Pliura, Executive Vice President of YM BioSciences. "This is robust confirmation that our approach not only provides rapid onset of pain relief, but permits extended duration of pain relief, while permitting patients to determine their own dosing requirements, and strongly supports our rationale for the expansion of development of this drug into the U.S."

YM further anticipates conducting an End-of-Phase II meeting with the FDA to discuss Phase III trial designs for registration. In addition, YM recently received clearance from the FDA to initiate a Phase II trial in the U.S. in patients who are either opioid tolerant or opioid naive, where a successful trial would further extend the utility and medical breadth of the product if and when approved. This trial is expected to initiate enrollment of its 50 patient target in the second half of 2007. The principal coordinating investigator is Eugene Viscusi, MD, Director, Acute Pain Management, Department of Anesthesiology, Jefferson Medical College, at Thomas Jefferson University, Philadelphia, Pennsylvania. Dr. Viscusi has published extensively in pain management world-wide.

"Results of this study were significant both clinically and statistically, and highlight the competitive advantages of our product and its potential as a best-in-class treatment for pain," said David Allan, Chairman and CEO of YM BioSciences. "We are very pleased that our upcoming trial will be led by a key opinion leader in the U.S. and look forward to discussions with regulatory authorities on the path to approval for our drug."

The Phase IIb clinical study (DLXLEF-AP4) was a 2-part, multi-center study to evaluate the efficacy, safety and tolerability of repeated, self-titrated inhalation of AeroLEF(TM) for the treatment of acute post-operative pain following orthopedic surgery. The first phase of the study (Part 1) was a 21 patient open-label, lead-in phase to ensure consistency of AeroLEF(TM) administration across study sites. Results of Part I of the Phase IIb study were presented at the 2006 American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL. The second phase (Part 2) was a 99 patient, randomized, placebo-controlled portion of the trial.

About AeroLEF(TM)

AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. In contrast to fixed-dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive delivery system designed to enable patients to self-titrate. Using AeroLEF(TM), patients can identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.

About YM BioSciences

YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company is advancing two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEF(TM), a proprietary, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

FYI: Bloomberg Article on Vectibix relabeling:

Amgen's Cancer Drug Vectibix Gets Stronger Warning (Update2)

By Luke Timmerman and Angela Zimm

June 20 (Bloomberg) -- Amgen Inc.'s new warning label for the cancer drug Vectibix is stronger than analysts expected, and that may favor a rival, ImClone Systems Inc.'s Erbitux.

The new prescribing information, posted on Vectibix.com and being printed up by the company, says patients in a trial who took the drug had a 6 percent rate of potentially fatal blood clots in their lungs, compared with 3 percent in a control group. Amgen said on March 22 that the clot rate was 4 percent.

Amgen, based in Thousand Oaks, California, halted a study of Vectibix with Genentech Inc.'s Avastin in March after it found that patients on the combination died sooner than those in a control group. Vectibix, approved in September for colorectal cancer, generated $51 million in the first quarter, about a third of what Erbitux, cleared more than two years earlier, made for New York-based Imclone during that period.

``ImClone's Erbitux stands to gain competitively, particularly if its comparable trial with Avastin, the Intergroup trial, continues to enroll safely,'' said Jim Reddoch, an analyst with Friedman Billings Ramsey in Arlington, Virginia, in a note to clients today.

Amgen's shares rose 8 cents to $58.21 at 1:47 p.m. New York time in Nasdaq Stock Market composite trading. The shares of ImClone rose 3 cents to $37.25.

Amgen proposed the stronger label to the FDA after the company reviewed results from the Pacce clinical trial, the study halted in March, said company spokeswoman Christine Regan. The U.S. Food and Drug Administration, which has six months to review the new label, hasn't yet commented on the wording or made any changes, Regan said.

An Interim Peek

``In March, the press release was based on the first interim peek at the data, and as the data matured, it has been updated,'' Regan said. The results of the Pacce study will be presented June 30 at the World Congress on Gastrointestinal Cancer in Barcelona, Regan said.

The label also includes new warnings that Vectibix doubled or tripled the risk of diarrhea, dehydration and infections, Reddoch wrote.

Eric Rowinsky, ImClone's chief medical officer, said that Erbitux has already been tested in combination studies including Avastin and there have been no safety complications so far. Data from an 800-patient trial combining Erbitux, Avastin and Roche Holding AG's Xeloda is expected by early next year.

``The FDA approved Vectibix on the basis of one trial, and Amgen does this complex trial in which the whole intent is to springboard Vectibix in front of Erbitux,'' Rowinsky said in a telephone interview today. ``I think the major setback is Amgen just doesn't have the data.''

To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net ; Angela Zimm in Boston azimm@bloomberg.net .
Last Updated: June 20, 2007 13:52 EDT

FYI: IMPT - Vectibix Label

7:44 (Dow Jones) The revised label for Amgen's (AMGN) cancer drug Vectibix reads worse than the company's March press release on the trial being stopped, Friedman Billings Ramsey writes. For example, the incidence of pulmonary embolism was higher than the press release and the specific increases in infections, diarrhea and dehydration are also spelled out. In general, FBR writes, Vectibix doubled or tripled the risk of those side effects. The news should put Vectibix sales estimates at risk and hurt AMGN's oncology franchise, the firm says. On the other end, Imclone's (IMCL) Erbitux stands to gain competitively, FBR says. (GS)

FYI: IMPT - Vectibix Label

7:44 (Dow Jones) The revised label for Amgen's (AMGN) cancer drug Vectibix reads worse than the company's March press release on the trial being stopped, Friedman Billings Ramsey writes. For example, the incidence of pulmonary embolism was higher than the press release and the specific increases in infections, diarrhea and dehydration are also spelled out. In general, FBR writes, Vectibix doubled or tripled the risk of those side effects. The news should put Vectibix sales estimates at risk and hurt AMGN's oncology franchise, the firm says. On the other end, Imclone's (IMCL) Erbitux stands to gain competitively, FBR says. (GS)

?: What gastric trial and which investigator?

FY ) 06/07 12:52PM ImClone- IMCL moves lower on DealReporter headline

ImClone-IMCL moves lower on DealReporter headline
According to DealReporter, ImClone's (IMCL) Erbitux gastric cancer drug candidate will not enter Phase III trials, investigator says

RE: IMCL Dow Wire ASCO Head & Neck Survival:

DJ Study Shows Erbitux Aids Survival In Head, Neck Cancer Cases
By Peter Loftus
Of DOW JONES NEWSWIRES

CHICAGO (Dow Jones)--A new European study showed the drug Erbitux extended
the lives of people with head and neck cancer, when used in combination with
chemotherapy.
Erbitux, co-marketed in North America by ImClone Systems Inc. (IMCL) and
Bristol-Myers Squibb Co. (BMY) and overseas by Merck KGaA (MRK.XE), was
approved by U.S. regulators last year to treat head and neck cancer. But the
approval was for its use in combination with radiation therapy, or as a single
agent when platinum-based chemotherapy has failed. In Europe, it's approved in
combination with radiation therapy.
The new study, funded by Merck KGaA of Germany, could support wider use of
Erbitux as a first-line treatment in combination with chemotherapy in head and
neck cancer patients. The drug also is approved to treat colorectal cancer.
The new study involved about 440 patients in Europe with advanced squamous
cell carcinoma of the head and neck. Most were cancers of the larynx or
pharynx. Roughly half were given chemotherapy plus Erbitux, while the other
half got chemotherapy alone.
The study found that median overall survival in the Erbitux/chemotherapy
group was 10.1 months, versus 7.4 months in the chemotherapy-alone group.
ImClone had disclosed in April that the study met its primary endpoint, but
full details are scheduled to be presented Saturday at the annual meeting of
the American Society of Clinical Oncology, or ASCO, in Chicago.
"The survival benefit is among the longest ever seen in a large clinical
trial among these patients," Jan Baptist Vermorken, a Belgian oncologist who
led the study, said in an ASCO press release.
The most common side effect in those taking Erbitux was an acne-like rash,
which was treatable and abated over time.
The European study was one of several Erbitux studies scheduled to be
presented at ASCO. The drug's marketers are hoping new clinical data will
support wider use of the drug and boost sales. Last year, Bristol-Myers
recorded $652 million in Erbitux sales, up 58% from the year before.
On Monday, results of a closely watched trial of Erbitux in previously
untreated colorectal cancer patients will be released. These data might also
support wider use of Erbitux because the drug is currently approved to be used
in colorectal cancer after chemotherapy has failed. ImClone already has said
the study met the primary endpoint of increasing median duration of
progression-free survival. Progression-free survival measures the time from
start of treatment until tumor growth or patient death.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com

(END) Dow Jones Newswires

RE: IMCL Dow Wire ASCO Head & Neck Survival:

DJ Study Shows Erbitux Aids Survival In Head, Neck Cancer Cases
By Peter Loftus
Of DOW JONES NEWSWIRES

CHICAGO (Dow Jones)--A new European study showed the drug Erbitux extended
the lives of people with head and neck cancer, when used in combination with
chemotherapy.
Erbitux, co-marketed in North America by ImClone Systems Inc. (IMCL) and
Bristol-Myers Squibb Co. (BMY) and overseas by Merck KGaA (MRK.XE), was
approved by U.S. regulators last year to treat head and neck cancer. But the
approval was for its use in combination with radiation therapy, or as a single
agent when platinum-based chemotherapy has failed. In Europe, it's approved in
combination with radiation therapy.
The new study, funded by Merck KGaA of Germany, could support wider use of
Erbitux as a first-line treatment in combination with chemotherapy in head and
neck cancer patients. The drug also is approved to treat colorectal cancer.
The new study involved about 440 patients in Europe with advanced squamous
cell carcinoma of the head and neck. Most were cancers of the larynx or
pharynx. Roughly half were given chemotherapy plus Erbitux, while the other
half got chemotherapy alone.
The study found that median overall survival in the Erbitux/chemotherapy
group was 10.1 months, versus 7.4 months in the chemotherapy-alone group.
ImClone had disclosed in April that the study met its primary endpoint, but
full details are scheduled to be presented Saturday at the annual meeting of
the American Society of Clinical Oncology, or ASCO, in Chicago.
"The survival benefit is among the longest ever seen in a large clinical
trial among these patients," Jan Baptist Vermorken, a Belgian oncologist who
led the study, said in an ASCO press release.
The most common side effect in those taking Erbitux was an acne-like rash,
which was treatable and abated over time.
The European study was one of several Erbitux studies scheduled to be
presented at ASCO. The drug's marketers are hoping new clinical data will
support wider use of the drug and boost sales. Last year, Bristol-Myers
recorded $652 million in Erbitux sales, up 58% from the year before.
On Monday, results of a closely watched trial of Erbitux in previously
untreated colorectal cancer patients will be released. These data might also
support wider use of Erbitux because the drug is currently approved to be used
in colorectal cancer after chemotherapy has failed. ImClone already has said
the study met the primary endpoint of increasing median duration of
progression-free survival. Progression-free survival measures the time from
start of treatment until tumor growth or patient death.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com

(END) Dow Jones Newswires

FYI: OXGN - early ASCO datapoints coming in:

OXGN OXiGENE announces phase II Combretastatin A4 Phosphate / CA4P study with paclitaxel and carboplatin shows safety, anti-tumor activity (4.80 +0.23)

Co announces the publication of two abstracts in the 2007 Annual Meeting program distributed this afternoon at the Annual Meeting of the American Society of Clinical Oncology in Chicago, IL. The first abstract reports for the first time full data from a randomized Phase II trial of Combretastatin A4 Phosphate / CA4P in combination with paclitaxel and carboplatin. In the abstract, lead author Dr. Wallace L. Akerley of the Huntsman Cancer Institute reports that the two dose regimens of CA4P studied, 45 mg/m2 and 63 mg/m2 in combination with paclitaxel and carboplatin, were well tolerated, demonstrated anti-tumor activity and reduced tumor blood flow by 46% and 19%, respectively. Tumor responses were observed and were similar between both dose groups, and the best overall response through cycle 6 was three partial responses and six stable disease responses as measured by RECIST criteria. The second abstract reports for the first time initial data from early dosing cohorts in a Phase I study of OXi4503 in patients with advanced solid tumors. Lead author Dr. Daniel M. Patterson of the Mount Vernon Cancer Centre indicates that while the study had not yet reached maximum tolerated dose and recruitment is ongoing, the data to date suggest that OXi4503 is tolerated at doses up to 5 mg/m2 without dose-limiting toxicity.

And I thought this wasn't allowed before your Oral at ASCO.

Re: BAY and ONXX

Bayer's Nexavar Had `Compelling' Results Against Liver Cancer

By Eva von Schaper

May 31 (Bloomberg) -- Bayer AG's Nexavar showed ``very compelling' results in a study of patients with liver cancer, the head of Bayer's drug unit, Arthur Higgins, said today.

The data, which will be presented at a scientific meeting on June 4, could enable Bayer to file for early approval of the drug in the U.S., Higgins said. Bayer, based in Leverkusen, Germany, already sells the drug with Onyx Pharmaceuticals Inc., of Emeryville, California, to treat advanced kidney cancer.

Nexavar belongs to a group of cancer drugs known as targeted therapies. Those also include Roche Holding AG and Genentech Inc.'s Avastin and Herceptin and Novartis AG's Gleevec. The medicines were among the first therapies designed to fight cancer while causing fewer side effects than chemotherapy does.

``We are very excited by this data,' Higgins said in an interview.

Nexavar, which competes with Pfizer Inc.'s Sutent, is also being tested for a range of cancers including non-small cell lung cancer and breast cancer.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .

And I thought this wasn't allowed before your Oral at ASCO.

Re: BAY and ONXX

Bayer's Nexavar Had `Compelling' Results Against Liver Cancer

By Eva von Schaper

May 31 (Bloomberg) -- Bayer AG's Nexavar showed ``very compelling' results in a study of patients with liver cancer, the head of Bayer's drug unit, Arthur Higgins, said today.

The data, which will be presented at a scientific meeting on June 4, could enable Bayer to file for early approval of the drug in the U.S., Higgins said. Bayer, based in Leverkusen, Germany, already sells the drug with Onyx Pharmaceuticals Inc., of Emeryville, California, to treat advanced kidney cancer.

Nexavar belongs to a group of cancer drugs known as targeted therapies. Those also include Roche Holding AG and Genentech Inc.'s Avastin and Herceptin and Novartis AG's Gleevec. The medicines were among the first therapies designed to fight cancer while causing fewer side effects than chemotherapy does.

``We are very excited by this data,' Higgins said in an interview.

Nexavar, which competes with Pfizer Inc.'s Sutent, is also being tested for a range of cancers including non-small cell lung cancer and breast cancer.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .

Also, Icahn's filings. Lots of changes passing by, but nothing on IMCL yet.

FYI: Crucial cancer trial will go ahead in Canada

Rival maker agrees to buy drug for testing on advanced colorectal tumours

LISA PRIEST

From Friday's Globe and Mail

May 11, 2007 at 5:19 AM EDT

A key clinical trial for cancer patients that Canada could not take part in because one drug company would not support it is going ahead in this country after all.

In an unusual move, a drug company will buy a rival's product, Avastin, so that hundreds of colorectal cancer patients across Canada can participate in the study run by the National Cancer Institute in the United States.

The study will answer two burning questions among oncologists who treat colorectal cancer: What drug works most effectively with chemotherapy: Avastin or Erbitux? Or do they work best together?

U.S.-based ImClone Systems Inc., which manufactures Erbitux, will provide not only its drug to patients participating in the study, but also Avastin, which is distributed in Canada by Roche Canada, holder of the Canadian licence.

Provincial governments have been eager to see the outcome of the trial, because several of them will fund drugs only if they are found to be cost-effective. However, most refuse to fund Avastin, which typically costs $36,000 for a course of treatment.

Avastin is available in Newfoundland and Labrador, British Columbia (which permits some compassionate access to it) and in at least one Quebec hospital.

As for Erbitux, Bristol-Myers Squibb Canada decided not to launch the drug it distributes and licenses after it failed to agree on a price with the federal Patented Medicine Prices Review Board. The Cancer Advocacy Coalition of Canada estimates Erbitux costs $56,000 for a standard course of therapy.

About 300 patients with advanced colorectal cancer will be able to get access to the new drugs as early as September as part of the trial. Last year, about 20,000 people in Canada were diagnosed with the disease, and about 8,500 died of it.

A Globe and Mail cancer series in November revealed that Canada could not be part of the trial because many metastatic colorectal cancer patients were not getting what is considered the standard of care in most of the world: Fluorouracil, a chemotherapy drug also known as 5FU, in combination with Oxaliplatin and Avastin.

Alan Venook is principal investigator of the trial and professor of clinical medicine at the University of California.

He called it marvellous that ImClone is buying Avastin, but said: "I think it's distressing that this is what it takes."

ImClone's vice-president of medical affairs, Dvorit Samid, said the total amount has not been tallied, but Roche Canada is selling the drug to them at cost.

"The trial is a very important question for patients," said Dr. Samid. "... Everybody hopes, all of us hope for the sake of patients, that when you take the two biological [drugs] and add to chemo[therapy], we will further improve the outcome."

In the fall, Sabrina Paiva, manager of communications and stakeholder relations for Roche Canada, said the company could not sanction a trial in which some patients would not receive Avastin. One group is getting only Erbitux and chemotherapy.

This week, she provided a written statement, saying: "We are currently in discussion with ImClone. In light of the fact that public funding is not available in most provinces, this study will provide another avenue for patients to get access to Avastin."

If the trial succeeds, Erbitux stands to become a substitute for Avastin or be added to the regimen of Avastin and chemotherapy.

Ralph Meyer, director of the National Cancer Institute of Canada's Clinical Trials Group, stressed there is still an approval process to go through, with a decision expected by the end of the month. After that, hospital research and ethics boards will decide whether to participate.

The trial will enroll 2,300 patients, most from the United States.

One hundred of the Canadian patients will receive chemotherapy plus Avastin, 100 will receive chemotherapy and Erbitux and 100 will receive chemotherapy, Avastin and Erbitux.

"Two out of three patients in this study will get access to Avastin, which we know improves survival, so, yes, this trial will be an important means to get treatment," said Derek Jonker, co-chair of the colorectal cancer working group for the National Cancer Institute of Canada.

As for Erbitux, while no provincial government funds that drug, in large part because it has not been marketed, some patients are still obtaining it.

The Ontario government has approved 172 patients to receive Erbitux in U.S. hospitals.

What the drugs do

Avastin, the trade name for bevacizumab, is a monoclonal antibody that prevents the growth of new blood vessels, helping to starve tumours and making it harder for cancers to grow. It offers a median of 4.7 months more of survival to patients with an incurable form of colorectal cancer. Specifically, clinical trials have shown that patients getting Avastin along with chemotherapy survived a median of 20.3 months, compared with 15.6 months for those receiving chemotherapy alone.

Erbitux, the trade name for cetuximab, is a monoclonal antibody that shrinks tumours in some patients and delays tumour growth, especially when used as a combination treatment. Late last month, the drug was found to prolong the lives of patients with incurable cancer. According to study results, the survival time of participants -- for whom other therapies had failed -- was, on average, six months for those patients given cetuximab, versus 4½ months for patients who received the best supportive care alone. Supportive care was defined as treatments to improve symptoms and quality of life.

Lisa Priest

FYI: PDLI Daniel Loeb is going to win this one.

16:50 PDLI PDL BioPharma: Cofounder announces support for refocusing of PDLI (25.87 +0.24)

Cary Queen, Ph.D., President of Nevada Venture Associates, sent to the Board of Directors of PDL BioPharma, (PDLI) the following letter today: "To the directors of PDL Biopharma: I write to you as cofounder of the co, inventor of the patents from which PDL derives much of its revenues, a significant shareholder, and a senior executive and Director of PDL for most of its history. I write to you in support of the proposals of Third Point LLC for a new direction at PDL that emphasizes efficiency, focus on product development, and profitability, under the leadership of a new Chief Executive Officer..."

FYI: How many times can you say IMCL

From Briefing on Rodman Renshaw comments below:

MEDI/AZN acquisition great news for the entire biotech space - Rodman and Renshaw

Rodman and Renshaw notes that AstraZeneca (AZN) will pay $15.6 bln to buy MedImmune (MEDI). In their view, this is great news for the entire biotech space. As big pharma begins to deploy its cash, aggressive steps like those that AZN is taking are positive for companies at both ends of the market cap spectrum. Cos that they think could be potential beneficiaries from today's mega-deal are: 1) antibody cos such as IMCL, XOMA, MEDX, PDLI 2) any co involved in a struggle with Carl Icahn (IMCL, TELK) 3) any co with excess biotech manufacturing capacity/antibody design/scale up (IMCL, XOMA, BIIB, HGSI); 4) any co in the vaccines space such as NVAX, VICL; 5) any co that has been in the takeover rumor mill in the past (CELG, MLNM); 7) other "middle weight" biotech cos like BIIB, CELG, GENZ, GILD, IMCL and PDLI, as they now found out there were four bidders in the run for a mature pipeline.

PDLI: Daniel Loeb is going to have his way with this one.

PDLI PDL BioPharma: Further details from Third Point letter to Directors (22.05 +0.46) -Update-

Inside today's press release Third Point also wrote " We also learned from sources we deem to be reliable that PDLI received a takeover bid from a large pharmaceutical co for more than $30 per share (approx 50% above the current stock price), which Mr. McDade effectively dismissed out of hand as being grossly insufficient. While we share the view that PDLI is significantly undervalued, we believe that due care requires management to present all such expressions of interest to the Board. We are not necessarily advocating a sale of the co at this time (although it should be carefully considered), but we believe that if such bidding interest exists, it should be carefully weighed against the present value of the Company in a scenario where it executes its long term operating plan under new, better-qualified management..."

Strange wording in the press release. Almost infers that subset information of interest will be made available for later presentation. This is not a give up in this indication.

Agree, but I just report, and this is what Citi/Smith Barney is publishing.

On a related note, he just picked up AMGN with the comment that it was transitioning from a bio multiple to a big pharma multiple, only without the dividend of the bigs. Opps: = GARP(growth at a resonable price).

Part of the rational: Erb vs Vex

FYI: IMS part II

Imclone’s Erbitux may be lower than our projections. For the month of February,hospital sales of ImClone Systems’ Erbitux were $50 million, a 10% increasefrom the weekly run-rate in January. We note that IMS Health hospital sales data have captured approximately 99% of actual sales since the February 2004
launch of the drug. However, on a monthly basis, the variability ranges between +15% and -10%. Based on the current run rate, hospital sales data suggests that sales of Erbitux are tracking at approximately $139 million in the first quarter, below our estimate of $169 million. We also note that negative data
from competitor Amgen’s Vectibix may increase future sales

Monthly MOM YOY

Dec-06 64,374 25.2% 33.61% 56,899 -1.8% 1 2,874.8 0.1%
Jan-07 45,731 -29.0% 16.22% 53,844 -5.4% 1 1,432.8 -11.2%
Feb-07 50,374 10.2% 15.41% 53,493 -0.7% 1 2,593.5 10.2%

FYI: IMS

What's New? Today, IMS released pharmaceutical hospital sales data for February 2007.
Epogen: Amgen’s Epogen sales were $242 MM, tracking about $50MM below our estimates of $631M assuming +35% mos/mos growth in March. Aranesp sales were $311 MM, in-line with our estimates. We expect March sales to be more fully reflective of this impact.
Vectibix: We also note that Amgen’s Vectibix IMS reported sales of $17MM suggest quarterly sales above our estimate of $47MM for Q1, although recent set-backs from the PACCE Study will likely impact future sales.
Erbitux: ImClone’s Erbitux sales were $50 MM. This represented a 10% WoW growth. The current run rate suggests that sales of Erbitux are tracking at approximately $139 million in the first quarter, below our estimate of $169 million. However, we note that negative data from competitor Amgen’s Vectibix may increase uptake in March.
Thalomid: IMS reported Thalomid sales in February of $24 MM, down 36% from the weekly run rate in January. However, given previous inaccuracies in Thalomid IMS data, we are looking to verify this figure with IMS as we are skeptical concerning the magnitude of the m/m dropoff.
Byetta posted sales of $42 MM. Byetta sales are currently tracking behind our Q1 est. of $158 MM at $141 MM accounting for an additional 5% growth in March.

FYI: New comp for Avastin in the toxic event arena

"Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities."

FYI: AMGN indicated down 2
IMCL indicated up 5
Y Werber at SB busy writing up his new sell thesis

Amgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluating Vectibix(TM) as Part of Triple Combination Regimen
By Business Wire
Last Updated: 03/22 05:36PM

THOUSAND OAKS, Calif.--Amgen (NASDAQ:AMGN) today announced that it has discontinued Vectibix(TM) (panitumumab) treatment in the PACCE trial evaluating the addition of Vectibix to standard chemotherapy and Avastin(R) (bevacizumab) for the treatment of first-line metastatic colorectal cancer (mCRC). The PACCE trial investigated a treatment regimen that used dual biologics combined with oxaliplatin- or irinotecan-based chemotherapy. This regimen is not currently used in clinical practice.


The decision to discontinue Vectibix treatment in the trial was based on a preliminary review of data from a pre-planned interim efficacy analysis scheduled after the first 231 events (death or disease progression). This analysis revealed a statistically significant difference in progression-free survival in favor of the control arm. An unplanned analysis of overall survival also demonstrated a statistically significant difference favoring the control arm. Additional analyses are ongoing, and Amgen plans to present the results at an upcoming scientific forum.


"Patient safety is Amgen's top priority. For this reason, we have decided to discontinue Vectibix treatment in the PACCE trial while we complete additional analyses of these preliminary results. We had hoped that adding Vectibix to the current U.S. standard-of-care for patients newly-diagnosed with mCRC would improve outcomes without excessive added toxicity. Unfortunately, it appears that adding Vectibix to Avastin, when used in combination with oxaliplatin- or irinotecan-based chemotherapy, increased toxicity, without improving efficacy," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.


Amgen has notified the FDA and study investigators that patients who are still receiving treatment in the PACCE study should discontinue Vectibix treatment. Patients will have the option of continuing per protocol treatment without Vectibix.


In January 2007, Amgen informed all investigators and regulatory authorities about safety information arising from a planned interim safety analysis of the PACCE trial. A review of the interim analysis showed an increased incidence of grade 3 severe events of diarrhea, dehydration and infections in the Vectibix-treated patients. In addition, an increased incidence of pulmonary embolism was observed in patients who received Vectibix compared with those who did not (4 percent and 2 percent, respectively). One (less than 1 percent) fatal event of pulmonary embolism occurred in a patient receiving Vectibix.


Amgen is continuing to explore Vectibix as a single biologic combined with chemotherapy in Phase 3 first- and second-line registrational trials. No other clinical studies are being modified at this time. However Amgen is evaluating data across all studies.


PACCE Study Design


The PACCE (Panitumumab Advanced Colorectal Cancer Evaluation) study is a Phase 3b randomized, open-label clinical trial evaluating oxaliplatin- and irinotecan-based chemotherapy and Avastin with and without Vectibix in the first-line treatment of patients with metastatic colorectal cancer. The trial is powered to show a 30 percent reduction in progression-free survival, the primary endpoint. Secondary endpoints include response rate, overall survival, duration of response and safety. The PACCE trial enrolled 1,054 patients (824 patients were randomized to receive oxaliplatin-based chemotherapy, and 230 patients were randomized to receive irinotecan-based chemotherapy) at 240 trial sites in the United States between Q1 2005 and Q3 2006.


About Vectibix


Vectibix is indicated for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.


Important Product Safety Information


Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.


Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

Amgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluating Vectibix(TM) as Part of Triple Combination Regimen
By Business Wire
Last Updated: 03/22 05:36PM

THOUSAND OAKS, Calif.--Amgen (NASDAQ:AMGN) today announced that it has discontinued Vectibix(TM) (panitumumab) treatment in the PACCE trial evaluating the addition of Vectibix to standard chemotherapy and Avastin(R) (bevacizumab) for the treatment of first-line metastatic colorectal cancer (mCRC). The PACCE trial investigated a treatment regimen that used dual biologics combined with oxaliplatin- or irinotecan-based chemotherapy. This regimen is not currently used in clinical practice.


The decision to discontinue Vectibix treatment in the trial was based on a preliminary review of data from a pre-planned interim efficacy analysis scheduled after the first 231 events (death or disease progression). This analysis revealed a statistically significant difference in progression-free survival in favor of the control arm. An unplanned analysis of overall survival also demonstrated a statistically significant difference favoring the control arm. Additional analyses are ongoing, and Amgen plans to present the results at an upcoming scientific forum.


"Patient safety is Amgen's top priority. For this reason, we have decided to discontinue Vectibix treatment in the PACCE trial while we complete additional analyses of these preliminary results. We had hoped that adding Vectibix to the current U.S. standard-of-care for patients newly-diagnosed with mCRC would improve outcomes without excessive added toxicity. Unfortunately, it appears that adding Vectibix to Avastin, when used in combination with oxaliplatin- or irinotecan-based chemotherapy, increased toxicity, without improving efficacy," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.


Amgen has notified the FDA and study investigators that patients who are still receiving treatment in the PACCE study should discontinue Vectibix treatment. Patients will have the option of continuing per protocol treatment without Vectibix.


In January 2007, Amgen informed all investigators and regulatory authorities about safety information arising from a planned interim safety analysis of the PACCE trial. A review of the interim analysis showed an increased incidence of grade 3 severe events of diarrhea, dehydration and infections in the Vectibix-treated patients. In addition, an increased incidence of pulmonary embolism was observed in patients who received Vectibix compared with those who did not (4 percent and 2 percent, respectively). One (less than 1 percent) fatal event of pulmonary embolism occurred in a patient receiving Vectibix.


Amgen is continuing to explore Vectibix as a single biologic combined with chemotherapy in Phase 3 first- and second-line registrational trials. No other clinical studies are being modified at this time. However Amgen is evaluating data across all studies.


PACCE Study Design


The PACCE (Panitumumab Advanced Colorectal Cancer Evaluation) study is a Phase 3b randomized, open-label clinical trial evaluating oxaliplatin- and irinotecan-based chemotherapy and Avastin with and without Vectibix in the first-line treatment of patients with metastatic colorectal cancer. The trial is powered to show a 30 percent reduction in progression-free survival, the primary endpoint. Secondary endpoints include response rate, overall survival, duration of response and safety. The PACCE trial enrolled 1,054 patients (824 patients were randomized to receive oxaliplatin-based chemotherapy, and 230 patients were randomized to receive irinotecan-based chemotherapy) at 240 trial sites in the United States between Q1 2005 and Q3 2006.


About Vectibix


Vectibix is indicated for the treatment of patients with epidermal growth factor receptor- (EGFr) expressing metastatic colorectal cancer after disease progression on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan- containing chemotherapy regimens. The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.


Important Product Safety Information


Dermatologic toxicities, related to Vectibix blockade of EGF binding and subsequent inhibition of EGF receptor-mediated signaling pathways, included but were not limited to dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.


Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, they have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.

Question: What does an hour and a half meeting during dinner time imply? Is PC data in? Is IMCL the late breaking oral?

NEW YORK--(BUSINESS WIRE)--March 21, 2007--
ImClone Systems Incorporated (NASDAQ: IMCL) announced today that the Company will host an analyst meeting to discuss clinical data presented on ERBITUX(R) during the 2007 American Association for Cancer Research (AACR) Annual Meeting. The meeting will be held on Tuesday, April 17, 2007 from 6:30 P.M. to 8:00 P.M. Eastern Time in the Academy Room on the Mezzanine Level of the
Hollywood Roosevelt Hotel in Hollywood, CA (7000 Hollywood Boulevard).

The meeting will be webcast live and may be accessed by visiting ImClone Systems' website at www.imclone.com. A replay of the webcast will be available under "Presentations" in the "Investor Relations" section of the Company's website within 24 hours after the conclusion of the meeting.

Question: What does an hour and a half meeting during dinner time imply? Is PC data in? Is IMCL the late breaking oral?

NEW YORK--(BUSINESS WIRE)--March 21, 2007--
ImClone Systems Incorporated (NASDAQ: IMCL) announced today that the Company will host an analyst meeting to discuss clinical data presented on ERBITUX(R) during the 2007 American Association for Cancer Research (AACR) Annual Meeting. The meeting will be held on Tuesday, April 17, 2007 from 6:30 P.M. to 8:00 P.M. Eastern Time in the Academy Room on the Mezzanine Level of the
Hollywood Roosevelt Hotel in Hollywood, CA (7000 Hollywood Boulevard).

The meeting will be webcast live and may be accessed by visiting ImClone Systems' website at www.imclone.com. A replay of the webcast will be available under "Presentations" in the "Investor Relations" section of the Company's website within 24 hours after the conclusion of the meeting.

FYI: May be relevant to IMCL

Bristol-Myers moves assets from Irish holding company-Irish Times
Sparking fears in Ireland that it is growing less competitive, drug maker Bristol-Myers Squibb (BMY) will reportedly move up to $25B in assets from Irish holding company, Bristol-Myers Squibb International Holdings Limited. A company spokesperson said the liquidation of assets in the holding company was "part of the company's ongoing review of its financial operations," but others speculate that the move was to benefit from even lower corporate tax rates elsewhere than in Ireland. [Reference Link]:[http://www.ireland.com/newspaper/breaking/2007/0316/breaking38.htm] (MI)