TNX-901: battle appears lost

7 replies [Last post]
By Kurt on Mon, 06-30-03, 16:05

A Web search today turned up the following link to an AP article published in the Las Vegas Sun on June 20, 2003. Disappointingly, it appears on the basis of what's written that Tanox has given up the legal battle and has suspended all work on TNX-901 while we wait years for Xolair to...hopefully...be approved for treatment of peanut allergy.

Key quotes:

"The drug's maker, tiny Tanox Inc. of Houston, halted the drug's development after losing a legal fight with its two bigger corporate partners, Genentech Inc. and Novartis AG.

It did this just as doctors prepared to conduct a larger human experiment designed to win FDA approval.

Tanox's powerful partners want to find out first whether peanut allergies also might be treated by the asthma drug created by Genentech, called Xolair, which was expected to win Food and Drug Administration approval.

But there has been little study of Xolair's effect on peanut allergies, and the FDA will require years of human experiments before Xolair can be used to treat some of the 1.5 million Americans who suffer from them. "

"After a public outcry, Tanox said this month that Smith and the 83 other volunteers who participated in the scuttled study would continue to receive TNX-901, at least temporarily.

Nevertheless, the companies are unsure when - if ever - the drug's development will resume."

"Thousands of sufferers and their families sent complaint letters to the companies in October after they said they would not continue developing TNX-901, according to advocacy group The Food Allergy and Anaphylaxis Network.

For their part, the companies said the legal squabbling is now behind them and that a decision on which drug to pursue will be based on science, not economics. They did not say when such a decision might be forthcoming.

"Its like a marriage with it's ups and downs," said Dr. Ashram Hannah, a Tanox vice president. "I'd characterize the relationship as improving and relatively positive. Much of the bad blood is no longer there."

Still, some see the partnership Tanox forged more than 10 years ago as a cautionary tale for other money-starved biotechnology startups looking to partner with cash-rich conglomerates. Because of the development deal Tanox signed, it can't pursue its core technology without its partners' involvement or permission.

"They've put themselves in a box," said Quyhn Pham, an analyst with Seattle-based Delafield Hambrecht Inc.

Hannah and Genentech officials said any delay in getting a peanut allergy treatment approved will be minor.

Even with the positive results and the FDA granting TNX-901 fast-track review status, the companies say the drug, like Xolair, is still a few years away from FDA approval because of the time it takes to conduct the final, pivotal study."

Although most of the article was presented above, the link to it, at least for now, is:

[url="http://www.lasvegassun.com/sunbin/stories/thrive/2003/jun/20/062006658.html"]http://www.lasvegassun.com/sunbin/stories/thrive/2003/jun/20/062006658.html[/url]

Kurt Schriever
Stewartsville, NJ

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By ajinnj on Mon, 06-30-03, 23:07

Hi Kurt!

I am Allison Smith (from the article) and I just wanted to let you know that the study has not been stopped. A few months ago, the study was abruptly stopped; however, thanks to all the people and organizations that wrote letters the companies agreed to continue the study until July 1. Just a few weeks ago I found out the study was continued for another 40 weeks!!! THere are several threads about this topic on the main board and living with PA board. I will raise them for you.

Allison

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By LoriHuhn on Tue, 07-01-03, 01:28

I guess the question is....aftr 40 weeks what happens? Is this considered their Phase III trials? Nobody seems to be answering those questions....have they told you anything?

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By Heather2 on Wed, 07-02-03, 18:16

I'm one of those people who wrote complaint letters. I'm glad the letters seem to have done some good. Especially after the brush-off letters I got from the companies in response.

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By ajinnj on Fri, 07-04-03, 21:36

actually i made a mistake. the study has been continued for 48 weeks. after that i'm not sure what is going to happen. i think that we are now in phase 3. all the study participants have been moved to the opitimal dose. thank you to everyone who write letters!

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By rebeccas on Sat, 07-05-03, 20:48

Thank you, Allison Smith, for your reply and information regarding the continued study!! I have a 5-year old son with an extremely severe PA. I am also one of those people who sent letters to Novartis, Tanox, and Genetech. Every night I pray that TNX-901 will prevail...your information gave our family a glimmer of hope.

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By JudyH on Sat, 07-05-03, 21:58

Thank you, Allison, for all of your posts. I hope you will chime in every so often and let us know how things are going.

Judy

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By ajinnj on Fri, 10-31-03, 22:48

raising for connie

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