Glaxo Says U.K. Rejects Diabetes Drug Application (Update3)
Bloomberg News
Mar 22 1999 3:38PM ET
Glaxo Says U.K. Rejects Diabetes Drug Application (Update3)
(Adds Salomon Smith Barney rating change, background.)
London, March 22 (Bloomberg) -- Glaxo Wellcome Plc, the biggest British drugmaker, said U.K. regulators rejected its bid to resume U.K. sales of a diabetes drug, which rival Warner- Lambert Co. sells in the U.S. as Rezulin.
U.S. regulators also are taking a closer look at the drug, licensed from Japan's Sankyo Co. A Food and Drug Administration panel Friday will review the drug and its potential to harm the liver. About 35
deaths have been linked to Rezulin, which has been taken by more than 1 million people worldwide.
Glaxo withdrew the drug, which it sold as Romozin, in the U.K. in December 1997 after it was linked to serious liver problems and at least five deaths. The U.K. Medicines Control Agency turned down
Glaxo's bid to reintroduce the drug, even with the addition of a liver monitoring program as is used in the U.S. Meanwhile, Glaxo has advanced work on a new diabetes medicine.
''It's not very good news at all for Rezulin,'' said Hemant Shah, an independent pharmaceutical analyst. ''It puts more pressure on the FDA. It also makes it difficult to see how other European regulators could approve the product now.''
Warner-Lambert, based in Morris Plains, New Jersey, fell 2 13/16 to 67 7/8 in late trading. Salomon Smith Barney analyst Christina Heuer cut her rating on Warner-Lambert to ''neutral'' from
''outperform.''
In London, Glaxo fell 11 pence to 1901p. In the U.S, American depositary shares of Glaxo fell 1/16 to 61 3/16. Glaxo said the U.K. Medicines Control Agency turned down the request on the Sankyo diabetes drug.
Phase II Testing
Glaxo's own diabetes drug in the second of three phases of testing required to apply for FDA approval. If the drug succeeds in this stage and subsequent, more extensive testing, it could be on the market in a few years, analysts said.
Glaxo now has no diabetes drugs of its own to sell, said Ramona DuBose, a company spokeswoman. Diabetes treatments are considered one of the more attractive markets for drugmakers. In the U.S. alone, about 15 million people now have Type II, or adult onset, diabetes.
Even with reports of liver problems and stringent warnings on the drug's label, Rezulin brought in $748 million in sales for Warner-Lambert last year.
Rezulin could face competition as early as this year from new drugs, such U.K.-based SmithKline Beecham Plc's Avandia and Actos, a Takeda Chemical Industries drug that Indianapolis-based Eli Lilly & Co. will sell. SmithKline and Takeda are expected to press to get information about possible lower incidence of liver side effects into their drugs' labels, if approved.
Celebrex
Monsanto Co. has built its new arthritis medicine Celebrex into a potential blockbuster in a similar way. Although the Celebrex label likens it to older painkillers, such as ibuprofen, the FDA let
Monsanto add information about studies that indicate Celebrex is less likely to irritate the stomach.
SmithKline said its Avandia hasn't caused liver damage in 21 studies, which included more than 5,000
participants. After hearing of the problems with Rezulin, SmithKline carefully examined the research
done on Avandia and didn't find the same side effects, the company said.
''That raises the question of why not,'' said Anthony Rebuck, director of clinical research for
SmithKline's diabetes drugs, in an interview last week.
Avandia may have an advantage in that it can control blood- sugar levels in much smaller doses than does Rezulin, Rebuck said.
Avandia pills contain about 4 milligrams to 8 milligrams of active medicine, while Rezulin pills contains 200 milligrams, 400 milligrams or 800 milligrams of medicine, Rebuck said. There is simply less of the drug needed to produce similar effects in the body, he said.
Rebuck is among the SmithKline researchers who will present the company's studies before an FDA panel on April 22. The panel will review Actos the next day.
Alternative
If SmithKline can persuade doctors that Avandia's a safer alternative to Rezulin, it likely will be able to quickly build the drug into a blockbuster, analysts have said. Another factor will be its cost. Rezulin costs about $5 a day, making it one of the more expensive diabetes treatments.
''If they're priced well and they don't have the liver side effects, you will see a lot of patients being switched'' from Rezulin to the new medicines, said Michael Pfeifer, director of the Diabetes and Obesity Center at East Carolina University School of Medicine.
He estimates about 250 of his 2,000 patients take the drug, which lets many patients avoid taking insulin shots. A diabetic himself, Pfeifer also takes Rezulin.
Still, the FDA likely will be skeptical of this sort of claim and require the new drugs to carry warnings about the possibility of side effects involving the liver, said Charles Engelberg, an analyst with
AmeriCal Securities.
''It would be a very big surprise to us if either drug had enough data to exclude'' language about liver side effects on the label, he said. ''It's way too soon to tell (whether the drugs are safer.) Maybe, five
years from now, we'll know.''
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