Pubdate: Mon, 05 Mar 2001 Source: Forbes Magazine (US) Copyright: 2001 Forbes Inc. Contact: 28 West 23rd Street, 11th Floor, New York, NY 10010 Fax: (917) 606-7262 Website: http://www.forbes.com/forbes/current/ Author: Zina Moukheiber DRUG WARRIOR When immunologist Philippe Pouletty was a resident at a hospital emergency room in Paris in the early 1980s, he was struck by the fact that, although 20% of patients admitted were drunks or drug addicts, doctors had no adequate treatment for them. Occasionally he would quiz drug industry executives on the problem: "Tell me which disease has 30 million chronic patients worldwide and costs 1% to 3% of the U.S. gross national product." "No one guessed addiction," Pouletty says. He decided to do something about it. In 1994 Pouletty formed his third biotech startup and named it DrugAbuse Sciences, basing it in Paris and Los Altos, Calif. and devoting it solely to developing treatments for alcohol and drug addiction. Pouletty, 42, now has six drugs in the pipeline, two of them in late-stage human trials—one for drunks and heroin addicts, the other for cocaine abusers. DAS has no revenue yet, paying its 25 scientists from the $30 million it has raised from ABNAmro, Edmond de Rothschild Asset Management and other investors. But most drug companies continue to shun addiction. Except for pockets of research in academia, drug companies have devoted almost no funding to searching for cures for drug and alcohol addiction. Most of their efforts target the $15 billion market for patches, gums and pills to get smokers off nicotine, leaving the rough stuff overlooked. "It falls at the top of unmet medical needs," says Peter Suzdak, research chief at Guilford Pharmaceuticals, which specializes in drugs for brain disorders such as Alzheimer's and Parkinson's. Drug and alcohol abuse costs the U.S. economy $300 billion in medical bills and lost productivity, according to federal government estimates. Some 14 million Americans are hooked on drugs and booze, outnumbering 8 million cancer patients almost 2-to-1 and schizophrenia patients 7-to-1. Eli Lilly's schizophrenia drug, Zyprexa, pulled in $2 billion in sales last year, yet sales of anti-addiction drugs amount to a mere $170 million a year, chiefly from naltrexone, for heroin and alcohol, buprenorphine, for heroin, and acamprosate, for alcohol. Yet the mechanics of addiction are more or less well understood. "We're further along in addiction than depression and schizophrenia," says David Self, a neuroscientist at the University of Texas Southwestern. To Pouletty, the industry's apathy recalls its attitude toward depression drugs in the 1980s, when marketers believed the market would amount to no more than $200 million per year. Prozac's release in 1988 stunned the skeptics and ignited a frenzy for feel-better pills; that market now tops $10 billion in annual sales. Treating addiction through medication, though, presents a tougher set of challenges. Getting junkies to cooperate with clinical trials can be tricky. The dropout rate ranges from 15% to 50%, compared with 3% to 4% for cancer and cardiovascular trials. Addiction carries a potent social stigma, too. Treating crackheads doesn't quite fit the wholesome image pharmaceutical companies want to project. Most past efforts have been incidental and have been abandoned at the earliest sign of failure. In 1996 Guilford came up with a compound that successfully blocked cocaine from binding with the brain's dopamine transporters, but it didn't stop the cravings. The company ended up scrapping its research. In the same year Abbott Laboratories had hopes that an experimental Parkinson's drug, ABT 431, could stabilize levels of dopamine in coke addicts. By raising depleted levels of dopamine, a feel-good molecule released in moments of pleasure, Abbott hoped to fend off the craving for cocaine. But the company struggled with formulations. When it scrapped its Parkinson's program, out went the cocaine experiments. DuPont markets a treatment for alcohol and heroin, naltrexone, which blocks the brain receptors involved in producing the highs from those substances, but it has been a major disappointment. Patients forget to take their daily tablet, so doctors don't widely prescribe it. Total naltrexone sales are a mere $30 million, despite the fact that major insurers often cover it. Pouletty, aiming to overcome those hurdles, is working with both naltrexone and Abbott's Parkinson's compound. To get around the problem of addicts failing to follow a drug regimen, DrugAbuse Sciences is developing a controlled-release version of naltrexone that requires only a monthly injection. Naltrel, as it is known, is in the last phase of human trials. So far one injection eliminated the highs experienced by a group of 15 heroin users for six weeks. And the company hopes to improve the absorption (and impact) of Abbott's 431 compound by developing it as an inhaler. DrugAbuse Sciences also is working on a cocaine vaccine, licensed from the Scripps Research Institute. Scripps scientists used lab rats to prove that the body's immune system can be prompted into destroying cocaine molecules before they cross from the blood into the brain. The vaccine is made from cocaine that has been chemically rendered inactive and attached to a bulky protein extracted from crabs. Pouletty's goal is to begin human trials by year-end. A similar vaccine from Cantab Pharmaceuticals in the U.K. is in midstage human testing. Pouletty is pursuing some original research, as well. This year he will start enrolling 6,000 alcoholics in seven European countries in an ambitiousproject to sequence 150 genes in the brain. By comparing genes of alcoholics with those who are not, Pouletty hopes to pinpoint any genetic anomalies that may make suitable drug targets. One blockbuster from Pouletty would likely set off a wave of anti-addiction drug development. But even he knows that all the medicine in the world can't offer a panacea for addicts. Ultimately they have to choose sobriety on their own. (SIDEBAR) Kicking The Habit Only a handful of anti-addiction drugs are slated to come to market soon. Drug Application Owner Status Subutex Heroin Developed Waiting for FDA addiction by Reckitt approval Benckiser; marketed by Schering-Plough. Campral Alcohol Merck KGaA Filing for addiction FDA approval Naltrel Alcohol DrugAbuse Late-stage clinical addiction Sciences trials TA-CD Cocaine Cantab Mid-stage addiction Pharmaceuticals clinical trials - --- MAP posted-by: Keith Brilhart