genentech has halted xolair trials

Posted on: Mon, 01/16/2006 - 6:18am
shoshana18's picture
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Joined: 02/02/2005 - 09:00

this was announced today...saw the article on cnn.com

Genentech said to halt allergy tests
Report: Biotech stops peanut allergy treatment trial after 'severe' reactions from two kids.
January 16, 2006: 8:23 AM EST

NEW YORK (CNNMoney.com) - Genentech Inc. put a stop to a clinical trial for a potential treatment for peanut allergies after two children suffered "severe" reactions during tests, according to a news report published Monday.

Genentech (up $1.32 to $87.46, Research), the world's second-biggest biotech, was conducting clinical trials of Xolair to see if the drug could prevent reactions to peanut allergies, when two of the 150 children in the trial experienced "severe hypersensitivity reactions" to a trace amount of peanut protein, The Wall Street Journal reported Monday.

The children had not been given Xolair, the report said, but were given the protein to test their reactions.

"We are not going to do that anymore," Genentech spokeswoman Susan Desmond-Hellmann told the newspaper.

Xolair is currently on the market as a treatment for allergic asthma and totaled $320 million in U.S. sales in 2005. Drug makers often test products for additional uses after they've already been approved for the market.

Genentech, based in South San Francisco, Calif., reported $5.9 billion in total worldwide sales for 2005. The biotech's top-selling products are Rituxan, a treatment for non-Hodgkin's lymphoma that totaled $1.8 billion in U.S. sales in 2005, and Avastin, a treatment for colorectal cancer with $1.1 billion in total U.S. sales.

Genentech last week reported a 64 percent surge infourth-quarter earnings, but this failed to impress some investors.

--

Posted on: Mon, 01/16/2006 - 9:13am
PeteFerraro's picture
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Joined: 07/10/2001 - 09:00

This SUCKS!
How many people have to die because Genentech cares only about the $$$$ that they will make on this drug as an Asthma drug.
------------------
Pete Ferraro
[url="http://www.FerraroFamily.org"]http://www.FerraroFamily.org[/url]

Posted on: Mon, 01/16/2006 - 10:36am
anonymous's picture
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Joined: 05/28/2009 - 16:42

I had the same immediate reaction, but in this case I think they were really fearful of killing a child. I'm hoping they will rework the clinical trial...to be safer and also make it larger than 150 people...we will see.
------------------
mom to Ari(5) - severe nut allergies, asthma, you name it - and Maya (8), mild excema

Posted on: Tue, 01/17/2006 - 10:56am
ajinnj's picture
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Joined: 05/13/2003 - 09:00

[url="http://www.mercurynews.com/mld/mercurynews/news/local/states/california/northern_california/13647148.htm"]http://www.mercurynews.com/mld/mercuryne...ia/13647148.htm[/url]
"Cohen said the drug had nothing to do with the severe reactions and the South San Francisco-based Genentech and its two corporate partners intend to continue the peanut-allergy program after consulting with the Food and Drug Administration.
"We remain committed," Cohen said."
Safety concerns halt Genentech peanut-allergy drug
PAUL ELIAS
Associated PressSAN FRANCISCO -
Biotechnology company Genentech Inc. has stopped development of a promising peanut-allergy treatment because of safety concerns raised during human experiments, a company spokesman said Tuesday.
Genentech officials stopped development of the drug last month after two volunteers had a more severe allergic reaction to peanuts than expected, spokesman Neil Cohen said.
Volunteers in the trial were given peanut protein to gauge how severe their allergies were and as a way to measure the effectiveness of the experimental drug, called Xolair.
Cohen said the drug had nothing to do with the severe reactions and the South San Francisco-based Genentech and its two corporate partners intend to continue the peanut-allergy program after consulting with the Food and Drug Administration.
"We remain committed," Cohen said.
The company had planned to test Xolair on 150 volunteers, but stopped after just 14 had completed the experiment, Cohen said.
Last year, Genentech and Novartis Pharma AG agreed to pay $6.6 million to Tanox Inc. to settle a bitter legal dispute related to Xolair, which has been approved for asthma treatment. All three companies will share Xolair's profits.
Xolair is a genetically engineered protein designed to block the same molecule, which plays a crucial role in setting off both asthma and allergy attacks.
The drug doesn't cure the allergy, but is designed to allow sufferers to avoid reactions caused by accidental contact with peanuts.
Between 50 and 100 people die a year because of these allergies, and thousands more suffer severe reactions such as constricted breathing and dramatic swelling. Allergic toddlers are especially at risk because they can't consciously avoid the surprising number of foods that contain peanut ingredients.
Genentech stock rose $1.96 a share, or 2 percent, to close at $89.42 in trading on the New York Stock Exchange.
Tanox's shares closed up 13 cents to $17.10 in trading on the Nasdaq Stock Market, while Novartis shares gained 62 cents to $55.52 in trading on the NYSE.
[This message has been edited by ajinnj (edited January 17, 2006).]

Posted on: Mon, 01/16/2006 - 9:13am
PeteFerraro's picture
Offline
Joined: 07/10/2001 - 09:00

This SUCKS!
How many people have to die because Genentech cares only about the $$$$ that they will make on this drug as an Asthma drug.
------------------
Pete Ferraro
[url="http://www.FerraroFamily.org"]http://www.FerraroFamily.org[/url]

Posted on: Mon, 01/16/2006 - 10:36am
anonymous's picture
Offline
Joined: 05/28/2009 - 16:42

I had the same immediate reaction, but in this case I think they were really fearful of killing a child. I'm hoping they will rework the clinical trial...to be safer and also make it larger than 150 people...we will see.
------------------
mom to Ari(5) - severe nut allergies, asthma, you name it - and Maya (8), mild excema

Posted on: Tue, 01/17/2006 - 10:56am
ajinnj's picture
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Joined: 05/13/2003 - 09:00

[url="http://www.mercurynews.com/mld/mercurynews/news/local/states/california/northern_california/13647148.htm"]http://www.mercurynews.com/mld/mercuryne...ia/13647148.htm[/url]
"Cohen said the drug had nothing to do with the severe reactions and the South San Francisco-based Genentech and its two corporate partners intend to continue the peanut-allergy program after consulting with the Food and Drug Administration.
"We remain committed," Cohen said."
Safety concerns halt Genentech peanut-allergy drug
PAUL ELIAS
Associated PressSAN FRANCISCO -
Biotechnology company Genentech Inc. has stopped development of a promising peanut-allergy treatment because of safety concerns raised during human experiments, a company spokesman said Tuesday.
Genentech officials stopped development of the drug last month after two volunteers had a more severe allergic reaction to peanuts than expected, spokesman Neil Cohen said.
Volunteers in the trial were given peanut protein to gauge how severe their allergies were and as a way to measure the effectiveness of the experimental drug, called Xolair.
Cohen said the drug had nothing to do with the severe reactions and the South San Francisco-based Genentech and its two corporate partners intend to continue the peanut-allergy program after consulting with the Food and Drug Administration.
"We remain committed," Cohen said.
The company had planned to test Xolair on 150 volunteers, but stopped after just 14 had completed the experiment, Cohen said.
Last year, Genentech and Novartis Pharma AG agreed to pay $6.6 million to Tanox Inc. to settle a bitter legal dispute related to Xolair, which has been approved for asthma treatment. All three companies will share Xolair's profits.
Xolair is a genetically engineered protein designed to block the same molecule, which plays a crucial role in setting off both asthma and allergy attacks.
The drug doesn't cure the allergy, but is designed to allow sufferers to avoid reactions caused by accidental contact with peanuts.
Between 50 and 100 people die a year because of these allergies, and thousands more suffer severe reactions such as constricted breathing and dramatic swelling. Allergic toddlers are especially at risk because they can't consciously avoid the surprising number of foods that contain peanut ingredients.
Genentech stock rose $1.96 a share, or 2 percent, to close at $89.42 in trading on the New York Stock Exchange.
Tanox's shares closed up 13 cents to $17.10 in trading on the Nasdaq Stock Market, while Novartis shares gained 62 cents to $55.52 in trading on the NYSE.
[This message has been edited by ajinnj (edited January 17, 2006).]

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