TNX-901: battle appears lost
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.
"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: