Monsanto, Merck pain drugs face FDA side-effect scrutiny
Monday August 3, 6:08 pm Eastern Time
By Ransdell Pierson
NEW YORK, Aug 3 (Reuters) - Monsanto Co. (MTC - news) and Merck & Co. (MRK - news) are racing to launch the first in a new class of pain and arthritis drugs but the rival companies first have to persuade U.S. regulators the medicines cause fewer ulcers and less gastrointestinal bleeding than existing remedies, analysts say.
The companies aim to introduce competing products in the class of drugs known as ''Cox-2'' inhibitors. They hope to snatch sales away from so-called NSAID drugs, which include over-the-counter standards like aspirin and ibuprofen, as well as prescription medicines like
naproxen.
''Cox-2 drugs could be the next blockbuster pharmaceuticals area because they will begin displacing NSAIDs (non-steroidal anti-inflammatory drugs), a huge market now worth $10 billion'' in annual sales, said ABN-AMRO drug analyst Mario Corso.
Monsanto's G.D. Searle pharmaceuticals unit is expected to seek U.S. Food and Drug Administration marketing approval any day for its experimental Cox-2 class drug Celebra (celecoxib) and to launch its product by early 1999, analysts said.
Merck has said it will file a New Drug Application with the FDA for its contender, Vioxx, by December. Merck's later filing is expected to give Searle a three-to-four-month jump in getting its product to market.
Corso said Celebra and Vioxx could each command annual sales of $2 billion globally within four years of their launch. They work by blocking the enzyme cyclooxygenase-2, known as Cox-2, which has been linked to pain and inflammation.
NSAIDs also work by inhibiting the Cox-2 enzyme. But they also block Cox-1, a related enzyme that protects the stomach lining, resulting in such side effects as ulcers and gastrointestinal bleeding, believed to be responsible for more than 7,000 deaths in the United States each year.
Searle and Merck have been secretive about their rival drugs, presumably because of an ongoing patent dispute.
Corso said limited clinical data released by the companies hint that their drugs are as effective as NSAIDs but spare patients the gastrointestinal side-effects by leaving the Cox-1 enzyme unaffected.
''The clear excitement about these drugs is that they have a superior side-effect profile to NSAIDs. And to prosper, they will have to be able to champion that advantage on their drug labels,'' Corso
said.
But Neil Sweig, a Southeast Research Partners drug analyst, cautioned that it is yet far from certain the FDA will allow either drug to make such superior safety claims.
''Being able to make a claim of better safety than NSAIDs will be the Holy Grail for these drugs. To succeed, they must show a significantly lower incidence of GI bleeding and ulcers,'' Sweig said.
''The jury is still out when it comes to the FDA and what safety claims it will allow,'' EVEREN Securities analyst Jeffrey Kraws said.
Even so, Kraws said he believes both drugs would win the right to make ''compelling'' claims of equivalent or better pain relief than NSAIDs with a lower incidence of GI effects.
Searle is expected to seek FDA approval to market Celebra for osteoarthritis, rheumatoid arthritis and pain, analysts said.
Officials at the Monsanto drug unit told Reuters they could not comment on Celebra because of regulatory restrictions on public statements posed by Monsanto's pending merger with Madison,
N.J., drugmaker American Home Products Corp. (AHP - news).
But Pfizer Inc. (PFE - news), which will co-market Celebra for Searle, indicated at a July 24 analyst meeting its belief that Celebra would be able to win FDA permission to claim on its label that its side effects are less than those of NSAIDs, Corso said.
Merck spokeswoman Rebecca Higbee said her company initially would seek approval to market Vioxx for osteoarthritis and acute and chronic pain, while continuing studies of the drug for rheumatoid arthritis.
''Our studies to date show our drug is as effective as NSAIDs with the safety profile of placebo,'' or dummy pills, she said.
Analysts noted that Vioxx would be a once-a-day drug, a possible marketing advantage to Celebra's twice-a-day dosing.
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