AMGEN KILLS - PD HOPES

how long can these S.O.B.s own the patent? anyone?

http://tinyurl.com/2gdw3q

19-20 years with normal extentions. But you can bet you bippy that they are working on peptide (oe "peptide like) variations of GDNF that they will hail as "more potent" or "longer lasting" in order to extend there patent protection well into the future, in an effort to finally "get it right" or "throw it away". cs

FYI - CERE-120 is a synthetic version of GDNF

It is probably the best therapy to come through the pipeline since GDNF.

1998
http://www.fool.com/portfolios/RuleB...amgn981215.htm



2005 -
http://users.mbi.ufl.edu/mandel/Appl...e_%20Story.pdf

http://www.amgen.com/investors/Annua...t2005/10-k.pdf

http://www.freshpatents.com/Glial-ce...0060166325.php

Health Highlights: May 9, 2007
05.09.07, 12:00 AM ET

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

Doctors Paid Millions to Prescribe Anemia Drugs

U.S. doctors are being paid millions of dollars a year by drug makers Amgen and Johnson & Johnson in return for prescribing anemia medicines to patients that may be unsafe at commonly used doses, The New York Times reported Wednesday.

According to industry analysts, the payments to doctors for prescribing the drugs -- Aransep and Epogen from Amgen; and Procrit from Johnson & Johnson -- may amount to hundreds of millions of dollars a year. The drugs are given to treat anemia caused by kidney disease or cancer chemotherapy.

Neither Amgen or Johnson & Johnson have revealed the total amount of the payments, which are structured in a way that make them legal under federal law, The Times reported.

Both patients and doctors would benefit from full disclosure about the payments and the profits doctors make from the payments, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.

On Tuesday, the Food and Drug Administration released a report suggesting that it may be necessary to limit the use of these anemia drugs in cancer patients. The report said research indicates that there's no evidence that the drugs improve quality of life or extend the lives of cancer patients. It also said that a number of studies suggest that high doses of the drugs may shorten patients' lives, The Times reported.

An FDA panel is scheduled to meet Thursday to discuss whether the drugs are overused. In March, the FDA ordered stronger warnings on the drugs' labels.

-----

Chinese Company Linked to Cough Medicine Deaths Not Licensed

The Chinese company linked to toxic cough medicine that killed at least 100 people in Panama was not licensed to be in the pharmaceutical business, say Chinese officials.

The cough medicine was tainted with a poisonous industrial solvent called diethylene glycol, that was falsely identified as glycerin, a sweet-tasting syrup widely used in medicine, The New York Times reported.

On Tuesday, a Chinese Foreign Ministry spokeswoman said the neither the chemical company that made the toxic syrup -- the Taixing Glycerine Factory -- nor the state-owned trading firm that exported it -- CNSC Fortune Way -- were under the regulatory supervision of China's State Food and Drug Administration.

The Chinese agency conducted an investigation in response to a request from the U.S. Food and Drug Administration, The Times reported.

-----

Cracker Barrel Pulls Hamburgers After Woman Injured

The Cracker Barrel Old Country Store restaurant chain has removed hundreds of hamburgers from its stores after a customer in Myrtle Beach, S.C. said she cut her mouth on a piece of metal in a patty, the Associated Press reported.

The restaurant chain removed more than 300 burgers made at or around the same time as the one involved in the incident. The burgers, which are frozen and pre-formed, were made by Cargill Meat Solutions of Wichita, Kan.

An investigation is being conducted by Cracker Barrel, the burger supplier, and police, the AP reported.

The 56-year-old female customer went to a hospital Saturday night after she began bleeding from the mouth and said something was stuck in her throat after eating part of a burger.

A police report said the restaurant manager found a piece of razor blade in the middle of the woman's half-eaten burger patty. Another piece of razor blade was later found in the patty.

The woman did not require stitches. Her husband said she was waiting to hear whether she need more medical tests, the AP reported.

Cracker Barrel has 557 restaurants in 41 states.

-----

FDA Approves Respirators For Use in Flu Pandemic

Two filtering facepiece respirators have been approved by the U.S. Food and Drug Administration for use in an influenza pandemic and other public health emergencies. They're the first to receive such approval.

The respirators, which help reduce a user's exposure to airborne germs, are available without a prescription. They're made by St. Paul, Minn.-based 3M Company.

The 3M Respirator 8612F and 8670F fit tightly over the nose and mouth and are made of fibrous material designed to filter out at least 95 percent of very small airborne particles.

"While the exact nature and concentration of the biological agent or germ may not be known in a public health medical emergency, we believe that minimizing exposure will help reduce risk," Dr. Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, said in a prepared statement.

"These respirators are only one part of a combination of approaches that can be used to help reduce the spread of infection between individuals during such events," Schultz said.

-----

VA Needs to Improve Handling of PTSD Claims: Report

Increasing numbers of U.S. veterans are suffering post-traumatic stress disorder (PTSD) and the Department of Veterans Affairs needs better methods of evaluating such cases and determining how best to compensate affected personnel.

That's the conclusion of a report released Tuesday by a combined committee from the Institute of Medicine and the National Research Council.

Post-traumatic stress disorder claims to the VA increased from 120,265 in 1999 to 215,871 in 2004. During that same time, payments for PTSD-related disability claims increased from $1.72 billion to $4.28 billion, the Associated Press reported.

"As the increasing number of claims to the VA shows, PTSD has become a very significant public health problem, particularly for veterans of current and past conflicts," said committee chairwoman Nancy Andreasen, who is head of the psychiatry department at Carver College of Medicine, University of Iowa.

"Our review of the current methods for evaluating PTSD disability claims and determining compensation indicates that a comprehensive revision is needed," Andreasen said.

She and her fellow panel members said the VA uses only crude criteria for rating disabilities caused by mental illness and is inconsistent when it comes to relapsing conditions, the AP reported.

The VA needs to develop new criteria based on the diagnostic standards of the American Psychiatric Association. The VA also needs to establish certification programs for staffers who handle post-traumatic stress disorder claims, the committee said.

-----

Scientists Develop New ALS Test

Scientists at the University of Toronto have created the first antibody that's able to detect the only known cause of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

ALS is a progressive, fatal disorder that attacks the nerves and muscles, resulting in paralysis and death within two to five years. There is no cure or effective treatment.

The antibody developed by the Canadian team identifies "misfolded" mutations in the enzyme superoxide-dimutase-1 (SOD1), which causes about one to two percent of all ALS cases, Agence France Presse reported.

The research was published online Monday in the journal Nature Medicine and will appear in the June print edition.

The study authors said their antibody could eventually be used to help diagnose ALS at an earlier stage. The antibody may also improve understanding of ALS and may help in efforts to find ways to immunize people against the disease, AFP reported.

"This antibody will enable researchers to investigate whether misfolded SOD1 is involved in other forms of ALS," lead author Janice Robertson, a professor of laboratory medicine and pathobiology, said in a prepared statement.

If SOD1 is involved in other forms of ALS, "then the antibody could potentially be used in biomarker studies to facilitate earlier diagnosis of the disease," she said.

-----

Clinton Foundation Reaches Deal on HIV/AIDS Drugs

The Clinton Foundation announced Tuesday that it has reached agreements with drug companies to reduce the costs of some HIV/AIDS drugs in developing countries.

The foundation said drug makers agreed to lower the price of drugs to fight HIV that is resistant to initial treatment, and to make a once-a-day HIV/AIDS pill available for less than $1 a day, the Associated Press reported.

The deals on the drugs to fight resistant HIV, reached with generic drug makers Cipla Ltd. and Matrix Laboratories Ltd., are expected to achieve average savings of 50 percent in middle-income countries and 25 percent in low-income countries, said former U.S. President Bill Clinton.

The agreement on the $1 once-a-day pills that combine the drugs efavirenz, lamivudine and tenofovir is 45 percent less than the current rate available for low-income countries and 67 percent less than the current price for many middle-income countries, the AP reported.

-----

I was reading your posts about the abortion of GDNF trials and found this article. All of you probably know about this, but I thought I would send it out anyway.
31 January 2006: Gene therapy hope for Parkinson disease treatment
SUMMARY: Gene therapy could help rescue a promising treatment for Parkinson disease (PD) shelved over safety fears, New Scientist magazine reports.
CONTEXT: The drug, glial-derived neurotrophic factor (GDNF), was withdrawn in September 2004 - just five months after it had been approved for use in patients. The biotech company that made the treatment, Amgen, stopped a US trial because it feared the protein might cause brain damage. However, a new technique for delivering GDNF via gene therapy could now alleviate these concerns.
Parkinson disease, which affects around 120,000 people in the UK, is caused by a gradual loss of cells in the area of the brain that controls movement. This results in tremors, muscle stiffness and eventual paralysis, even though the muscles themselves are unaffected. The disease is associated with a lack of dopamine, a brain communication chemical. In 2000, a group of US scientists showed that GDNF could promote the growth of dopamine-producing nerve cells in monkeys affected by a PD-like illness, alleviating their symptoms.
Patients enrolled in Amgen's trial had showed some improvement, but the company halted the experimental treatment over fears that it would cause brain damage similar to that seen in monkeys. Now, another US biotech firm called Rheogene might have come up with a solution: they have designed a gene therapy treatment that allows scientists to precisely control how much GDNF is delivered to the brain. It involves the use of a 'switch' attached to the GDNF gene that is only turned on in the presence of a chemical called diacylhydrazine, which can be given as a pill. 'When it's off, it's off', said Mark Braughler of Rheogene.
COMMENT AND ANALYSIS: This research, as yet unpublished, demonstrates a potential new gene therapy technique that could eventually be used to help PD patients. The company hopes that it can begin clinical trials in 2008, after completing tests on rodents and monkeys. They also say that the system could potentially be used for other gene therapy treatments, by replacing the GDNF gene with a different target gene.
Reprieve for 'risky' Parkinson's drug
New Scientist
31 January 2006
http://www.newscientist.com/channel/...25364.800.html

This looks like a safe place to jump in and talk about BIO because it was a fantastic experience and pure networking, in most cases for large dollar amounts. BIO has big big money! oh wipe the surprised look off your faces .....lol..being very dry here.

They have money coming out of the cracks in the walls.There were several sets of steep, long, steps as one way out of the exhibition hall and every single step was painted with the word Amgen. Blue steps, white paint. Just steppin out. A cookie always awaited at the end.

I'll save the description of one of the extravagant galas for another post. The pipeline project shared a table with PDF [translator?] lol......and had, as the Russian break dancer in Everything is Illuminated liked to say,"a premium location." We were on a main drag and directly across a short carpet that simply everyone eventually walked by on, from Genentech hee hee!

On the sides of them were Genzyme [paid for the Fox luncheon] , Johnson and Johnson, Merck, I could go on.

This area attracted lots of attention, too, because of the focus on PD and the FOX outstanding - finally hittin homeruns with patients too - keynote address.

Getting finally to the point, there are many small molecules out there and everyone knows about GDNF. What most didn't realize, especially if from out of the US, was that when they approached our table and we explained we were sponsored by PDF but a separate patient focus, a few got the glazed over look but most brightened up as soon as they realized...connecting two very disjointed thoughts here badly... we had done our homework as we suffered.

Don't want this to be too long and there's plenty more. Many stories and you are all going to be subjected to them if you want to read.

I'll finish by saying this. I understand your desire to find it...but in the meantime, people should be helping us........personally I think that's a better idea. rick....and could be a very effective one.

ooo almost made it through without a pitch. maybe someone else could invest a little time explaining what I'm trying to convey.

Off to dance to Still the One by Linda Ronstadt - we must exercise.

paula

I am beginning to agree with you. Reinventing the wheel is not an efficient use of energy.

But, Paula, won't it be difficult for you to persuade your group to follow my lead?

OK. I'll be serious. I've always felt obligated to save the world but that becomes harder every day. I will learn more about what you are doing and help if I can. -Rick