Glaxo withdraws drug in US
01 Dec 2000
British pharma major, Glaxo Wellcome, whose merger process with SmithKline Beecham has been prolonged by regulatory approval delays, suffered yet another blow when it voluntarily withdrew its drug for irritable bowel syndrome, Lotronex, from the US market.
The decision to withdraw, coming on the heels of a request by the US Food and Drug Administration, which was concerned about reports of some deaths associated with the drug, is likely to be extended to the rest of the world, including Europe, where the drug is awaiting regulatory clearance for marketing. The withdrawal of the drug is likely to have over $35 million impact on its books.
Lotronex has always been considered as one of Glaxo's brightest hopes in terms of generating revenue, with analysts predicting that it could deliver more than $1 billion worth of revenues to Glaxo. Now, with the recall, revenue projections are being scaled down.
While Glaxo's management disagreed with the FDA, it has pulled the drug off the shelves as a precautionary measure. Glaxo officials believe that Lotronex is effective and, with the side-effects being manageable, the benefits of the product when treating irritable bowel syndrome outweigh the risks. The company had argued that Lotronex was only dangerous when it was mis-prescribed, mainly to older women with constipation. It hopes to re-introduce the drug in the market with a more explicit label on the side effects.
The company, which once had an excellent record with regulators around the world, is suddenly facing several blow marks. Very recently another Glaxo drug, Relenza, a flu treatment was forced off the shelves by regulatory concerns over safety and efficacy.
