Monday, October 17, 1994
After the long wait to compare the results of Biogen Inc.'s pivotal trial of beta interferon with the results of Berlex/Chiron Corp.'s version, the only thing that's crystal clear is that both drugs work. So assuming that the FDA approves BGEN's product expeditiously, in all likelihood the drugs will play out their competition in the marketplace in about 18 months.
To get a sense of how well Betaseron has penetrated the market and thus what BGEN will be up against, BioCentury talked to several neurologists about their current treatment practices: how they are making treatment decisions with regard to Betaseron, what percentage of their eligible patients they're putting on the drug and any problems they're encountering with its use.
They then were asked which drug they would choose once both are on the market given what's known today about each.
Finally, several marketing consultants discussed how they would position each drug: how they would counsel Berlex to defend its established position; and how they would advise BGEN to build a franchise.
All six of the clinicians interviewed are putting their eligible patients on Betaseron, which was approved for use in the relapsing-remitting form of the disease. Betaseron's pivotal trial hinged on the drug's impact in reducing exacerbations or flare-ups of the disease and didn't reach statistical significance in ameliorating disability as was shown by BGEN's data last week (see BioCentury Extra, Oct 11).
Some, like Kenneth Johnson of the University of Maryland, are sticking to the label guidelines. Johnson was a principal investigator in the Betaseron trial as well as Teva Pharmaceuticals' copolymer- I trial and has worked with beta interferon.
He recommends that ambulatory relapsing-remitting MS patients start using the drug very early. "In some cases with the first attack we wait to see what the clinical disease is like, but we tend to start more rather than fewer patients early," he said. The university has about 150 patients on the drug. He hasn't recommended its use in patients with chronic progressive disease.
William Sibley of the University of Arizona also is writing prescriptions for all eligible patients who want to be on Betaseron "because I think the data are pretty compelling."