Friday, August 14, 2009

Medarex is Giving away the Company without it's Shareholders Consent at a Fireside Sale to Bristol-Meyer Squibb of 50 % off! Melanoma Jim Breitfeller

Headline Pfizer's melanoma disappointment compounds Medarex misery

Source EP Vantage

Company Medarex

Related: Bristol-Myers Squibb, Pfizer

Date April 02, 2008

The termination of a phase III trial of tremelimumab in melanoma, after interim data suggested the drug was no better than standard chemotherapy, could mean Pfizer has lost one its most promising pipeline products.
While the company is not abandoning the antibody, which is in trials for a range of solid tumours, the prognosis is not good, and is the last thing Pfizer needs as it attempts to drive through new products ahead of the looming loss of Lipitor. For Medarex, the news is an even bigger blow, because it makes potential future royalty payments look more uncertain, and adds to concerns around a similar antibody the biotechnology firm is developing with Bristol-Myers Squibb.
Tremelimumab, or CP-675,206, is an anti-CTLA4 antibody which targets a molecule found on the surface of T-cells, and has been shown to diminish the immune response to tumours. By using a human antibody to block the activity of CTLA-4, immune systems may attack tumours more strongly.
There are two anti-CTLA4 MAb’s under development, tremelimumab and ipilimumab, both in final stage trials for melanoma. The Pfizer drug was developed using technology similar to Medarex’s, hence the royalties due on future sales. The latter, also known as MDX-010, was developed by the biotechnology group, and is being progressed under the alliance with Bristol-Myers Squibb.
The consensus net present value of MDX-010 to Medarex is $1.23bn, according to EvaluatePharma’s NPV Analyzer, which represents just over a third of the total value of the group’s pipeline. CP-675,206 is valued at $547m, accounting for just under a fifth, meaning half of the company’s pipeline value is tied up in the success of anti-CTLA4 MAbs.
Medarex shares were trading 15% lower, at $7.88, in early trade.

Second most important

Pfizer shares also opened weaker, down 1%. The consensus NPV of the product is $2.29bn, representing 2% of the company’s share price. That makes it the second most important pipeline project, after axitinib.
Analysts had penciled in sales of $499m by 2012, and were anticipating launch this year. The product is phase II trials in non-small cell lung cancer, colorectal and breast cancers, among others.
Melanoma would be a big opportunity for both CP-675,206 and MDX-010, because the cancer represents a significant unmet medical need. The main drugs used to fight the disease are the interferon alphas, sales of which are in decline as newer, more effective products have been developed for other tumour types, with melanoma remaining hard to treat.
If the antibodies fail to make the grade, the indication will lose two its most promising looking new candidates.

Diminishing hopes

Hopes that the anti-CTLA4 MAbs would prove to be a significant new treatment options were lowered when Bristol-Myers and Medarex released mixed results from three registration phase III trials of ipilimumab in December. One study did not meet the primary endpoint, although the companies have stressed that response rates across the trials were positive.
MDX-010 is due to be filed with the FDA in the first half of the year, and Medarex has expressed confidence that the regulator will approve the drug on the data. Sales forecasts commence in 2008, given the fast track status the drug has been granted, but confidence in straight-off approval has diminished, with many analysts believing further trials will be required.
A sign that Bristol-Myers is also less than confident came in a December slide show given by the company, which showed sales of MDX-010 starting in 2010.
Consensus for 2012 sales sits at $389m recorded by Bristol-Myers. A key event for defining the potential of the drug will come when full data from the three phase III trials is presented at this year’s ASCO conference at the end of May.
With today’s set back, that presentation takes on even greater importance for the biotechnology group. Its shares fell 21% when the news on MDX-010 was announced in December, and aside from a recent small rally, have been falling since.
With the stock now trading at three-year lows, significant progress with the remainder of its pipeline is needed to restore confidence.

This content is written, edited and published by EP Vantage and is distributed by EvaluatePharma Ltd. All queries regarding the content should be directed to: news@epvantage.com
EP Vantage is a unique, forward-looking, news analysis service tailored to the needs of pharma and finance professionals. EP Vantage focuses on the events that will define the future of companies, products and therapy areas, with detailed financial analysis of events in real-time, including regulatory decisions, product approvals, licensing deals, patent decisions, M&A.
Drawing on EvaluatePharma, an industry-leading database of actual and forecast product sales and financials, EP Vantage gives readers the insight to make value-enhancing decisions.



Source: EvaluatePharma®
Source:
http://www.evaluatepharma.com/Universal/View.aspx?type=Entity&entityType=Product&lType=modData&id=10530&componentID=1002#&&_ViewArgs=%7b%22_EntityType%22%3a0%2c%22_Parameters%22%3a%7b%22_ContextData%22%3a%22%7b%5c%22isEPVantage%5c%22%3atrue%2c%5c%22percentage%5c%22%3a-1%2c%5c%22searchWords%5c%22%3a%5c%22%5c%22%2c%5c%22sectionID%5c%22%3a%5c%22%5c%22%2c%5c%22storyID%5c%22%3a%5c%22152431%5c%22%7d%22%7d%2c%22_Type%22%3a1%7d


Based on this information plus 1.5 bn for the othe 39 drugs in the pipeline plus 1.23 for mdx-010 and 2.29 for Tremelimumab, or CP-675,206 equals 5.02 bn

Lets do the math 2.4 bn/16per share = 5.02 bn/X X= 33.5 dollars per share

BMY got a half off deal.


Show us the $$$$$$$$$$$!!!!!!!!!!

Medarex List of products in the pipline!!!! 14-Aug-09 10:13 pm
Product Count
Medarex
Marketed 3
R&D 62
Suspended in R&D 1
Abandoned in R&D 42
Disposed in R&D 1
Total (Medarex) 109

DEPTH COMPETITIVE INTELLIGENCE AVAILABLE ON

Product Generic Name
Medarex
aB7H4
-
ADC Research Program
-
AFP-VAC
-
ALT-212
-
AMG 714
-
Amgen Antibody-1
-
Amgen Antibody-2
-
Amgen Antibody-3
-
Amgen Antibody-4
-
Amgen Antibody-5
-
Anti-bacterial MAb
-
Anti-CD70 MAb-MGBA conjugate
-
Anti-Cripto-1 MAb
-
Anti-CTLA-4 project
-
Anti-SDF-1 MAb
-
aPtk7
-
ARIUS/Medarex Cancer Research Project
-
AutoImmune MAb Collaboration
-
Avalon Cancer Antibody Collaboration
-
BMS-66513
-
Cancer antibody collaboration
-
Cancer MAb Project
-
Cancer Research Project
-
CDX-110
-
CDX-1307
-
CDX-1401
-
CDX-2101 (inc. Ribi-529 adjuvant)
hepatitis B vaccine

CDX-2301
anthrax vaccine

CDX-2401
-
CDX-2410
-
CDX-S03
-
CNTO 95
intetumumab

COL-VAC
-
Compugen antibody collaboration
-
CP-675,206
tremelimumab

DTS-201
-
Duocarmycin B2
-
Eos/Medarex/Biosite Cancer MAb
-
Euroscreen MAb collaboration
-
FG-3019
-
Fully-Human RSV MAbs
-
Graft versus Host Disease Project
-
GVHD-TOX
-
Haematological cancer MAb collaboration
-
HGS-TR2J
-
HuMax-CD4
zanolimumab

HuMax-Inflam (MDX-018)
-
IL-13 Antibody
-
Ilaris
canakinumab

IMC-18F1
-
IMC-3G3
-
Immunology MAb collaboration
-
Infectious Disease Research Project
-
Ipilimumab
ipilimumab

KW-2189
pibrozelesin

LOR-A04
-
Lung Cancer MAb
-
MAb Research Project
-
MAGE3
-
MDX 1097
-
MDX-060
iratumumab

MDX-066
-
MDX-067
-
MDX-070
-
MDX-11
-
MDX-1100
-
MDX-1105
-
MDX-1110
-
MDX-1185
-
MDX-1203
-
MDX-1204
-
MDX-1338
-
MDX-1342
-
MDX-1388
-
MDX-1401
-
MDX-1411
-
MDX-1414
-
MDX-214
-
MDX-22
-
MDX-220
-
MDX-240
-
MDX-33
-
MDX-44
-
MDX-447
-
MDX-RA
-
Medarex/Pfizer UltiMAb Antibody
-
Medarex/Raven MAb
-
MEDI-545
sifalimumab

MEDI-546
-
MelanA
-
MEL-VAC
-
NI-0401
-
Novartis Antibody 2
-
NY-ESO-1
-
OGeS cancer antibody collaboration
-
ONO-4538 / MDX-1106
-
Organon/Medarex MAb
-
Osidem
-
Ovarian Cancer MAb
-
PSA-VAC
-
Resiquimod (inc. CDX-1307 adjuvant)
-
SARS MAb
-
Second-generation MDX-070 toxin conjugate
-
Simponi
golimumab

Stelara
ustekinumab

Transcobalamin MAb
-
Valortim
-
VAP-1 Antibody Program
-
Vitamin B12 Receptor Blocking MAb

Take Care,

Jimmy B
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Greetings to One and All

This Blog is dedicated My Brother Kenny B. who passed away in the late 1970's with Cancer before the Internet.

It was he, who showed me How to live and give back. He was wise beyond his years.


Kenny B




Jimmy and Dee

Carepage: Jimmybreitfeller
Jimmy Breitfeller


My Profile as of 2009

My photo
Last July (2005)I was riding my bicycle to work at the Eastman Kodak Research Labs about 3 miles from home. I was wearing a knapsack to carry my things to and from the labs. I started noticing an ache on my back. So I decide to go to the dermatologist. To make the long story short, it was cancer. I knew from my research that I would be needing adjuvant therapy. So I started communicating with Sloan Kettering, University of Pittsburgh Cancer Center, and a couple of others including the Wilmot Cancer Center at Strong. I realized that by telling my story, I might help someone else out there in a similar situation. So to all who are linked by diagnosis or by relation to someone with melanoma, I wish you well. Stay positive, read as much as you can (information helps to eliminate the fear associated with the unknown), and live for today, as no one can predict what tomorrow may bring. Jimmy B. posted 12/15/08

Disclaimer

The information contained within this Blog is not meant to replace the examination or advice of your Oncologist or Medical Team. The educational material that is covered here or Linked to, does not cover every detail of each disorder discussed.

Only your physician/Oncologist can make medical decisions and treatment plans that are appropriate for you. But, An Educated Consumer is a Smart consumer.

As Dr. Casey Culberson Said:

"The BEST melanoma patient is an ACTIVE PARTICIPANT in his or her treatment
(not a PASSIVE RECIPIENT)"

Melanoma and the “Magic Bullet” (Monoclonal Antibodies)

Just to let you know I posted the first draft of the Melanoma and the “Magic Bullet” (Monoclonal Antibodies). on Melanoma Missionary In the Shared File Section. you can download it for 19.95 (Only kidding) it is Free for the taking.


It is 33 pages long and may help you in your quest for the Yellow Brick Broad. Just to let you know it is only the first draft. Revisions are sure to come. I wanted to get it to the people that need it the most, the Melanoma Patients.

Preview:

So, where does Interluekin-2 (IL-2) come into play? According to Byung-Scok et al and recent reports, IL-2 is not needed for developmental CD4+ CD25+ Treg cells in the thymus but does play an important role in the maintenance and function in the peripheral.18 Peripheral is defines as secondary system outside the bone marrow and thymus. It entails the site of antigen, immune system interaction. IL-2 is required for the peripheral generation of Tregs based Abbas’s and colleagues research.19

IL-2 prevents the spontaneous apoptosis of the CD4+ CD25+ Treg cells. It has been reported that patients with multiple advance-stage tumors have elevated levels of Tregs within the tumor microenviroment.20 Interluekin-2 is the survival factor for CD4+ CD25+ Treg cells.21 If the addition of IL-2 is on or before the maximum propagation of the CD4+ T cells, the Tregs population can increase 5-fold in a 96 hour period based on certain growth mediums.

By controlling the addition of the endogenous IL-2, one has a knob to turn and can lead to the control of the expansion of the Tregs. When you combined this control with the anti-CTLA-4 blockage, you can shift the balance of the immune response.

Now here is the catch. The maintenance and function of the CD8+ T-cells require CD4+ cells which secrete IL-2. So we don’t want to deplete the CD4+ cells, we want to control the expansion of the Tregs which are a subset of the CD4+ cells. It has been postulated by some researchers that the Anti-CTLA-4 blockage also suppresses the Treg function in a different mechanism. By using IL-2 as the rate limiting factor, we can suppress the CD4+ CD25+ Treg cell expansion by controlling the concentration and timing of the Inerluekin-2 at the tumor microenvironment.


The Interluekin-2 plays another role in this Melanoma Maze. In a study by Janas et al, Il-2 increases the expressions of the perforin and granzyme A, B and C genes in the CD8+ T-cells. This increase expression causes the CD8+ T-cells to mature into Cytoxic T Lymphocytes (CTLs). The exogenous IL-2 is required for the granzyme proteins. As stated previously, CTLs have cytoplasmic granules that contain the proteins perforin and granzymes. A dozen or more perforin molecules insert themselves into the plasma membrane of target cells forming a pore that enables granzymes to enter the cell. Once in the tumor cell, these enzymes are able to breakup (lyse) the cell and destroy it. This is the beginning of the end for the cancer cells. The tumors begin to shrink and the rest is history,

“

On the other hand, prolong therapy with Il-2 can result in causing apoptotic death of the tumor- specific CD8+ T-cells.23

Clearly in a clinical setting, timing, dose, and exposure to these drugs play a major roll in the immunotherapy, and can have dramatic effects on the outcome.

All it takes is that one magic bullet to start the immune reaction..

https://app.box.com/shared/kjgr6dkztj

Melanoma And The Magic Bullet (Monoclonal Antibodies)

Public Service Announcement

A call for Melanoma Patients by Dr. Steven A Rosenberg

"We continue to see a high rate of clinical responses in our cell transfer immunotherapy treatments for patients with metastatic melanoma", Dr. Rosenberg said.

"We are actively seeking patients for these trials and any note of that on a patient-directed web site would be appreciated."

If you would like to apply for his trials, here is the website and information.

Dr. Rosenberg's information


Dr. Rosenberg's Clinical Trials


For the Warriors




The Melanoma Research Alliance has partnered with Bruce Springsteen, the E Street Band, and the Federici family to alleviate suffering and death from melanoma. Please view Bruce Springsteen’s public service announcement inspired by Danny Federici. Danny was the E Street Band’s organist and keyboard player. He died on April 17, 2008 at Memorial Sloan-Kettering Cancer Center in New York City after a three year battle with melanoma.


http://www.melanomaresearchalliance.org/news/PSA/

Source Fastcures blog



Join the Relay for Life!!!

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Dear Family and Friends,

I’ve decided to take a stand and fight back against cancer by participating in the American Cancer Society Relay For Life® event right here in my community! Please support me in this important cause by making a secure, tax-deductible donation online using the link below.

To donate on line now, click here to visit my personal page.
Jimmy B AKA Melanoma_Missionary

Relay For Life® is a life-changing event that brings together more than 3.5 million people worldwide to:

CELEBRATE the lives of those who have battled cancer. The strength of survivors inspires others to continue to fight.

REMEMBER loved ones lost to the disease. At Relay, people who have walked alongside people battling cancer can grieve and find healing.

FIGHT BACK. We Relay because we have been touched by cancer and desperately want to put an end to the disease.

Whatever you can give will help - it all adds up! I greatly appreciate your support and will keep you posted on my progress.

Keep the Fire Burning!!!

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Sincerely,

Jimmy Breitfeller
Turn off Music before you "Click to Play"
Signs of Melanoma Carcinoma Skin Cancer

How Skin Cancer Develops by "About.com : Dermatology"

Call for Patients with Unresectable Liver Metastases Due to Melanoma



Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma


Delcath is actively enrolling patients in a Phase III clinical trial testing its proprietary drug delivery system, known as Percutaneous Hepatic Perfusion (“PHP”), with melphalan for the treatment of ocular and cutaneous melanoma metastatic to the liver.

This NCI-led trial is enrolling patients at leading cancer centers throughout the United States. Commenting on these orphan-drug designations, Richard L. Taney, President and CEO of Delcath, stated, “These favorable designations are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our pivotal Phase III trial for metastatic melanoma. We remain steadfast in our commitment to become the leader in the regional treatment of liver cancers and we continue to enroll patients in this study, and advance our technology and the promise that it offers to patients with these deadly forms of melanoma and other cancers of the liver, all with limited treatment options.”

Orphan drug designation, when granted by the FDA’s Office of Orphan Products Development, allows for up to seven years of market exclusivity upon FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.


Current Trial Centers


Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemofiltration Using
Percutaneously Placed Catheters in Patients With Unresectable Hepatic Malignancies


James F. Pingpank, Jr., MD, FACS
Associate Professor of Surgery
Division of Surgical Oncology
Suite 406, UPMC Cancer Pavillion
5150 Centre Avenue
Pittsburgh, PA 15232
412-692-2852 (Office)
412-692-2520 (Fax)
PingpankJF@UPMC.edu


Blog Archive

Call For Melanoma Patients!!!!

Call For Melanoma Patients!!!!

Dr. Rosenberg Has a New Clinical Trial.

Our latest treatment has a 72% objective response rate with 36% complete responses.

We are currently recruiting patients for our latest trial.

Is there some way to post this “Call for Patients” on the web site?

Steve Rosenberg

Dr. Rosenberg's Clinical Trials



(For a copy of the research paper.. see My Shared files)

The news headlines shown above for Melanoma / Skin Cancer are provided courtesy of Medical News Today.