[PFE/MTC's Celebra] Painkillers Top 'Wonder Drugs' List JUNE 16, 19:29 EDT
By JOHN HENDREN AP Business Writer
NEW YORK (AP) - Drug makers, eyeing Viagra's runaway success with profit envy, expect the drive for arthritis relief will yield the next wonder drug.
Some industry experts believe Celebra, a painkiller that cuts inflammation but avoids the stomach-damaging effects of aspirin, ibuprofen and acetaminophen, could outsell the impotency drug by millions of dollars a year.
Drug makers' ceaseless efforts to stock America's medicine chest have long plowed research money into trying to ease such ills as cancer, obesity and chronic pain. But the road to a cancer cure is littered with promising treatments that fizzled. And last year's recall of two diet pills left many dieters wary of weight-loss drugs.
Now comes a new class of super painkillers with a singular advantage: They could be on pharmacy shelves within months. And industry watchers believe millions of Americans will gladly toss their bottles of common painkillers for an alternative that saves their stomachs.
Kathryn Howe already has.
Rheumatoid arthritis left the 51-year-old executive secretary's joints so swollen she couldn't type or take long walks. Rolling over in bed hurt.
She kept the swelling under control with prescription-strength versions of drugs such as Tylenol and Advil. But 15 years of them left her with an inflamed stomach and rectal bleeding. Last year, her doctor asked her to test an unapproved drug called Celebra. Now she walks, swims, does low-impact aerobics and even lifts weights comfortably with no apparent side effects.
''A person can shake my hand and I'm not in pain,'' the Eastlake, Ohio, resident said. ''I can hold a pencil.''
Some analysts predict Celebra will outsell Viagra, the lucrative Pfizer Inc. impotency treatment that became the fastest-selling drug in history its first month.
''That's what I would put my finger on as the next blockbuster drug, not only in terms of medicinal value but in terms of cult following,'' said Stephen Tang, a drug industry specialist with A.T. Kearney, a management consulting firm in New York.
Typical estimates call for annual Viagra sales to reach $3 billion by 2002. Celebra sales could eventually top $4 billion, said Salomon Smith Barney analyst Christina Heuer.
With the global market for prescription painkillers, not including over-the-counter sales, at $5 billion, Ms. Heuer predicts Celebra could be ''the most significant new drug introduction of 1999.''
Celebra is expected to be the first out of the blocks from a new class of drugs called cox-2 inhibitors, so named because they block the inflammatory enzyme cyclooxygenase. Aspirin and similar anti-inflammatory drugs do that too, but they go too far, also blocking the cox-1 enzyme that protects the stomach lining.
Doctors believe the new class of painkillers may also provide a significant side benefit. Patients are more likely to get better faster, or improve more profoundly, if they're willing to take their medicine and stay on it.
When Mrs. Howe was prescribed standard anti-inflammatory drugs that hurt her stomach, she conceded, ''I wasn't a very compliant patient.''
Celebra's manufacturer, Monsanto Corp.'s Searle unit, is expected to ask the Food and Drug Administration for an expedited six-month review by September. If that happens, the drug could be on the market by early next year in the United States and late 1999 abroad.
Having tested Celebra's effects on rheumatoid arthritis, osteoarthritis and dental pain, scientists are now researching signs that Celebra might help prevent colon cancer and Alzheimer's disease, in which cox-2 is believed to play a role.
If it is approved for rheumatoid arthritis, the most severe joint disease, doctors would be free to prescribe it for a number of painful conditions.
Searle will have to move quickly. Merck & Co. is about six months behind in developing a rival painkiller named Vioxx. Glaxo Wellcome PLC, Johnson & Johnson and Roche Laboratories also have cox-2 drugs on the way. Already Merck and Searle are entangled in a legal battle over patents.
Monsanto, Searle's parent, has agreed to be acquired by American Home Products Corp., but the new owner won't be marketing Celebra. Searle signed up Pfizer for that agreeable task long before the acquisition.
Whoever handles it, Wall Street appears to be betting on Celebra.
''Cox-2, that's potentially the next big blockbuster, and I think Monsanto and Pfizer have the upper hand,'' said Hemant K. Shah, an independent drug industry analyst in Warren, N.J. ''The first product always has the advantage.''
Prozac's $2.6 billion in worldwide sales, for instance, makes it the best-selling antidepressant years after similar rivals - Pfizer's Zoloft, Glaxo's Wellbutrin, SmithKline Beecham's Paxil - came on the market.
In addition to the cox-2 class, Wall Street analysts recognize several candidates as wild-card contenders in the race for the next wonder drug:
- Pfizer's antibiotic Trovan. Ms. Heuer estimates the drug could bring in $1.5 billion in 2002, matching 1997 sales of SmithKline's top-selling antibiotic Augmentin.
- Avandia, an oral diabetes drug by SmithKline. Analysts say it could become a blockbuster if it lacks the side effects of Warner-Lambert's Rezulin, which was pulled from the market in the United Kingdom after a few patients suffered liver failure.
-Leptin, Amgen Inc.'s weight-loss hormone. Some patients lost 35 pounds in six months, but doctors remain wary of obesity drugs since last August's recall of the diet pills fenfluramine - one half of the popular fen-phen drug cocktail - and Redux. Knoll Pharmaceuticals' new diet pill, Meridia, drew a lackluster 11,185 prescriptions last month, according to researcher IMS Health. Leptin is also being tested on diabetes patients.
But even blockbusters will have a hard time topping Viagra, with an unprecedented 1.7 million prescriptions in three months.
''There's never been a drug like this so far in the history of the business,'' said Joseph P. Riccardo, a drug industry analyst at Bear Stearns & Co. in New York. |