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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?


To: Ibexx who wrote (7352)4/6/1999 9:18:00 PM
From: BigKNY3  Read Replies (2) | Respond to of 9523
 
Merck's "savior" painkiller awaits Monsanto rival

By Ransdell Pierson

NEW YORK, April 6 (Reuters) - Merck & Co. <MRK.N> is counting on an experimental painkiller named Vioxx to be its salvation as the nation's largest drug maker faces the loss of billions of dollars in revenue by 2001 from expiring patents on three of its currently best-selling drugs.

But Vioxx, now awaiting U.S. regulatory approval, will have to achieve almost immediate blockbuster sales in the face of unexpectedly brutal competition from Monsanto Co.'s <MTC.N> rival painkiller Celebrex, analysts said.

They said Vioxx must generate billions of dollars of annual sales for Merck to maintain double-digit earnings growth after patents expire in 2000 on its ulcer drug Pepcid and hypertension treatment Vasotec and in 2001 on anti-cholesterol agent Mevacor.

The three aging Merck drugs had combined global revenues of $4.26 billion in 1998, more than 25 percent of the company's drug sales last year. However, their sales are expected to plummet once the patents expire and other companies flood the market with generic versions of the compounds.

"Vioxx must get to $2 billion or more by 2001 to offset revenues that will be lost because of those patent expirations," said Neil Sweig, a New York-based drug analyst for Southeast Research Partners.

Vioxx and Celebrex are the first members of a promising new class of prescription drugs that work by selectively blocking the so-called COX-2 enzyme. They have been dubbed "Cox-2 inhibitors."

The U.S. Food and Drug Administration is expected to decide by May 23 whether to approve Vioxx (rofecoxib) for osteoarthritis, general pain relief and management of menstrual pain. An FDA advisory panel is scheduled to review Vioxx safety and efficacy issues on April 20-21. The FDA usually follows the recommendations of its advisory panels. The FDA typically either approves or denies the drug within a month or two after a panel meeting.

"I don't think there's any doubt Vioxx will be approved. It's a fait accompli in my opinion," said Ira Loss, a Washington-based analyst for HSBC Securities Inc.

Celebrex (celecoxib), launched in January for osteoarthritis and rheumatoid arthritis, is one of the best-selling new drugs in history with over 300,000 prescriptions a week being filled.

Merck and Monsanto products will battle to dominate the global analgesic market, currently an $8 billion pie consisting of a wide range of prescription and over-the-counter drugs. The U.S. market alone is pegged at $4 billion a year and quickly growing.

Studies suggest Vioxx and Celebrex work as well as older pain treatments known as non-steroidal anti-inflammatory drugs (NSAIDs) while causing far fewer ulcers and gastrointestinal problems -- a major marketing advantage for the two new painkillers.

NSAIDs such as aspirin, ibuprofen and naproxen also block COX-2. But they simultaneously inhibit the related COX-1 enzyme which protects the stomach lining, causing gastrointestinal problems that kill an estimated 16,500 Americans each year.

Monsanto estimates 21 million Americans suffer from osteoarthritis, the breakdown of joint cartilage from normal wear and tear. About 2 million Americans have rheumatoid arthritis, a far more serious disease in which the body's own immune system attacks joints.

ABN-AMRO analyst James Keeney predicted Vioxx will be launched by June and have a devilishly hard time catching up with Celebrex.

"Celebrex has had a faster uptake than perhaps any drug in history and its strong headstart will be a serious negative for Vioxx," said Keeney, who speculated most arthritis patients taking Celebrex would be unwilling to switch over to Vioxx.

Nevertheless, he predicted Vioxx would garner annual sales of $1.8 billion by 2001, enough to ensure company earnings growth of about 11 percent that year. Keeney said sales would come thanks to the vast number of osteoarthritis patients who want safe pain relief.

"Celebrex will be a very tough act for Vioxx to follow," said Sweig, although he predicted Vioxx could achieve sales of $2 billion in 2001 due to pent-up demand for safer analgesics.

Loss noted that Monsanto had enlisted Pfizer Inc <PFE.N> to co-market Celebrex, a fact which he said guarantees fierce hand-to-hand combat with Vioxx.

When the smoke clears, however, Loss said both drugs will emerge victorious. "The battle will expand the whole market for COX-2 drugs, whose combined sales could reach $6 billion within four years. The losers will be the NSAIDs."

13:31 04-06-99