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Monsanto's Celebrex Wins FDA Approval, but Battle with Merck Far from Over

Strategic Insights

— 1 min read

The Food and Drug Administration (FDA) has approved Monsanto's Celebrex, a revolutionary type of arthritis medication, as the first "cox-2" inhibitor to hit the market. However, in a blow to Monsanto, the FDA declared that there is no proof that Celebrex is safer for patients' stomachs than older painkillers. As a result, when Celebrex becomes available in retail outlets next month, it will bear the same warning about side effects as many of its older competitors. Meanwhile, Merck, which is awaiting FDA approval for its Vioxx drug, another cox-2 pill, hopes to get a less stern warning label and gain an advantage over Monsanto.

Key Takeaways:

  • Celebrex, made by Monsanto's Searle pharmaceutical unit, is the first "cox-2" inhibitor to win FDA approval, allowing it to become the first revolutionary type of arthritis medication on the market.
  • However, the FDA declared that there is no proof that Celebrex is safer for patients' stomachs than older painkillers, leading to a warning label with the same cautions as many of its competitors.
  • Merck, with its Vioxx drug, hopes to get a less stern warning label, which could be a key driver of physician use and potentially lead to annual sales of $1 billion.
  • Merck may gain an additional advantage by getting approval for Vioxx to be taken only once a day for arthritis users, while the recommended dose of Celebrex is once or twice a day for osteoarthritis and twice a day for rheumatoid arthritis.
  • Analysts believe that Merck may be able to use Monsanto's experience to get a better label, potentially giving them a competitive edge in the market.
  • The warning label for Celebrex and the plan for Merck's Vioxx could significantly impact the sales and approval of these painkiller drugs.

Statistics:

  • The recommended dose of Celebrex is once or twice a day for osteoarthritis and twice a day for rheumatoid arthritis.
  • The warning label for Celebrex will be similar to that of many of its older competitors.
  • Shares of Monsanto rose $1.19 to $47.50 after the FDA ruling, while shares of Merck dropped $1.31 to $147.50.

Sources:

  • Associated Press, "Monsanto wins FDA approval for arthritis drug; Merck may get better label"

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