Infighting Halts Allergy Drug Progress

By PAUL ELIAS : AP Biotechnology Writer
Jun 20, 2003 : 9:19 pm ET

SAN FRANCISCO -- The nurse called Allison Smith with the news: The experimental drug that so effectively treated her severe peanut allergy was being taken away. Once again, she would have to face a world where even the slightest accidental exposure to a peanut could kill her.

"They abruptly said the study was over," the Ocean Township, N.J. teen said, recalling the panic that set in immediately after that February phone call. "I was devastated."

The drug, dubbed TNX-901, had won raves from allergists, passed key human tests and federal regulators agreed to accelerate the process to judge its fitness for widespread use.

All that has been trumped, though, by bitter infighting and squabbling among corporate partners over potential profits.

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.

Whichever drug reaches market first, Tanox will share in the profits.

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.

Between 50 and 100 people die a year due to these allergies, and thousands more suffer severe reactions such as constricted breathing and dramatic swelling. Allergic toddlers are specially at risk because they can't consciously avoid the surprising number of foods that contain peanut ingredients.

Parents of allergic children lament how the allergy has drastically altered their lives -- they can't trust their children to play unattended in public places for fear of accidental peanut contact, and their kids are restricted in what gatherings their children can attend -- as peanut-tinged food may be served at birthday parties or preschool snacks.

"Every place is a minefield," said Pamela Gaiter, the mother of 3-year-old sufferer Benjamin.

There's no cure for the allergy, but TNX-901, injected once a month, is the treatment closest to being approved. Researchers reported positive results in the New England Journal of Medicine, and their presentation wowed attendees at the American Academy of Allergy, Asthma and Immunology meeting in Denver this March.

The drug doesn't cure the allergy, but increases sufferers' tolerance to the point that nearly all cases of accidental contact don't provoke reactions. Some people who would otherwise react to the slightest touch of a peanut could, after injecting TNX-901, ingest nine peanuts before an allergic reaction.

"This is my light at the end of the tunnel," said Gaiter, who pulls her boy out of preschool before lunch each day and worries endlessly that he'll have an allergic reaction in the local playground in Walnut Creek, Calif. "The infighting with these companies is making me sick. Kids are dying."

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.