Hummmm....I wonder if this is news? What do they expect the CEO of Merck to say?!
Thursday April 29, 10:06 pm Eastern Time
Merck says Vioxx pain drug has edge over Celebrex
(adds details, quotes, Monsanto response, paras 12-20)
By Ransdell Pierson
NEW YORK, April 29 (Reuters) - Merck & Co.'s(MRK - news) experimental pain drug Vioxx has several advantages that will assure quick success despite the head start enjoyed by rival Celebrex, launched in January by Monsanto Co.(MTC - news), Merck's chief executive said Thursday.
In an interview with Reuters, Raymond Gilmartin said he expected sales of Vioxx would play a big role in offsetting potentially large revenue losses expected by 2001, when five of Merck's key prescription drugs -- including hypertension drug Vasotec and ulcer pill Priloseclose -- lose U.S. patent protection.
An advisory panel of the U.S. Food and Drug Administration last week recommended approval of Vioxx for treatment of pain associated with osteoarthritis and for acute pain, such as from dental surgery.
Wall Street expects the FDA to approve Vioxx by May 23. Whitehouse Station, N.J.-based Merck has said it intends to begin shipping the drug within days of the approval.
Vioxx will have to play catchup with Celebrex, already racking up over over 300,000 new U.S. prescriptions each week -- a faster takeoff than any drug in recent memory, including Pfizer Inc.'s (PFE - news) impotence pill Viagra.
Vioxx and Celebrex are members of a new class of drugs that ease pain by selectively blocking the COX-2 enzyme linked to inflammation.
Standard remedies known as non-steroidal anti-inflammatory drugs (NSAIDs) also block the enzyme, but can cause deadly ulcers by also blocking the COX-1 enzyme that protects the stomach lining.
''Based on the acceptance of Celebrex, this is a very large and very unsatisfied market,'' Gilmartin said, referring to the need for a new class of pain treatments that are safer than NSAIDs.
He said Merck had been concerned whether doctors and patients would embrace COX-2 drugs. ''That was the critical uncertainty, and it has been resolved (favorably),'' he said, by the success of Celebrex.
Celebrex was approved for treatment of pain associated with osteoarthritis and rheumatoid arthritis. An estimated 21 million Americans suffer from osteoarthritis, the breakdown of joint cartilage from normal wear and tear. About 2 million have rheumatoid arthritis, in which the body's own immune system attacks joints.
But Gilmartin said the FDA refused to approve Celebrex for acute general pain because of Monsanto's less-than-compelling data. ''The fact that we have a pain indication is a differentiation. It is an indicator basically of the efficacy and potency of Vioxx.''
Celebrex is taken once or twice a day for osteoarthritis and twice a day for rheumatoid arthritis, while Vioxx is taken once a day for both osteoarthritis and acute general pain.
''Vioxx has a longer sustained duration over a 24-hour period'' for pain, Gilmartin said. He said other data showed Vioxx patients ''can take the drug at any time of the day and wake up in the morning without the stiffness which is a problem for people with osteoarthritis.''
The later launch of Vioxx ''will not be a major handicap,'' Gilmartin said, because the Merck drug will differentiate itself from Celebrex as the only COX-2 drug approved for general pain and having ''true once-a-day dosing.''
But Monsanto scientist Dr. Steve Geiss said clinical trials of Celebrex showed it also worked ''all day long, regardless of whether a patient takes it once a day or twice a day. And our patients also wake up without stiffness.''
Gilmartin said Merck was also counting heavily on increasing sales of 14 other drugs and vaccines launched since 1994 to fill the revenue gap once patents expire on its five older medicines by 2001.
''Vioxx by itself could never really do it. It's really the cumulative affect of Vioxx and the other 14 drugs that are still growing strongly that will allow us to overcome the patent expirations,'' Gilmartin said.
Analysts have predicted Merck will launch two intravenous drugs by 2001 that could each generate annual sales of $500 million -- the antifungal Cancidas and the cephalosporin-class antibiotic MK-826.
But many continue to question whether they, Vioxx and Merck's existing medicines will indeed capture enough revenues to allow the world's largest drug maker to continue generating double-digit earnings growth.
Gilmartin said many earlier-stage Merck experimental drugs also hold promise, including a so-called ''naked DNA'' vaccine against the HIV virus that causes AIDS. He said initial data from clinical trials of the vaccine were expected within ''a couple of years.''
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More Quotes
and News: Merck & Co Inc (NYSE:MRK - news)
Monsanto Co (NYSE:MTC - news)
Pfizer Inc (NYSE:PFE - news)
Related News Categories: chemicals, health, insurance, US Market News
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