Glaxo Wellcome Abandons Plans to Sell IBS Treatment Lotronex Globally

Strategic Insights -

Glaxo Wellcome, the UK's largest drugs company, has abandoned plans to sell Lotronex, its irritable bowel syndrome (IBS) treatment, after US regulators demanded a recall due to safety concerns. The decision follows a failed attempt to persuade the US Food and Drug Administration (FDA) that Lotronex's benefits outweigh its risks, which was sparked by reports of five fatalities linked to the medication. Glaxo's representatives met with the FDA two weeks ago to request an independent scientific assessment of Lotronex, but their proposal was rejected. The company had previously tightened the warning label on the drug in August, but this was not sufficient to alleviate the FDA's concerns.

Key Takeaways:

  • Glaxo Wellcome has abandoned plans to sell Lotronex globally due to safety concerns raised by the US FDA.
  • The FDA rejected Glaxo's proposal to conduct an independent scientific assessment of Lotronex after receiving reports of five fatalities linked to the medication.
  • The company had previously tightened the warning label on the drug in August, but this was not enough to address the FDA's concerns.
  • Glaxo denies any causal link between Lotronex and the reported fatalities, stating that the side effects cease when patients are taken off the medicine.
  • The decision will dent sentiment towards Glaxo, which is finalizing its merger with SmithKline Beecham, and reinforce the weakness of its research and development track record.
  • Lotronex's development is estimated to have cost £500m, with additional costs incurred in building up a sales force.
  • Peak sales were forecast to reach £450m.

Statistics:

  • £500m: estimated cost of developing Lotronex
  • £450m: forecast peak sales of Lotronex
  • 38: number of countries outside the US where Glaxo had filed applications to sell Lotronex
  • 5: number of fatalities linked to Lotronex
  • 2 weeks: time period between Glaxo's meeting with the FDA and the decision to abandon plans to sell Lotronex
  • August: month when Glaxo tightened the warning label on Lotronex

Sources:

  • The Times (reported by the Financial Times)
  • Public Citizen (US consumer group)
  • Glaxo Wellcome (through various press releases and statements)
  • FDA documentation (not explicitly cited, but referenced as part of the regulatory process)