fyi. SBH published clinical data from their TZD, Avandia, at the American Diabetes Association meeting this weekend. Key points:
1 - 493 patient 26 week study, showed it significantly reduced blood sugar (no data in article) and was free of serious side effects. Also noted the drug has been tested in 5,500 patients.
Fyi, apparently the FDA will require 12 month data for future glucose lowering drugs, although Rezulin was approved on 6 month data.
2 - As Henry has pointed out here, Avandia is 100x as potent as Rezulin
3 - Merrill Lynch predicts $1.8B in sales in 2005 if the clinical data shows it to be better than Rezulin (clinical data should bear this out). SKB expects to file the NDA in 1999
4 - Article also mentions a third TZD in the clinic, piglitizone from Takeda, licensed to Lilly (who else?) ... as has been discussed here.
SmithKline Diabetes Drug Appears Safe, Effective, Study Shows
Chicago, June 14 (Bloomberg) -- SmithKline Beecham Plc's experimental oral diabetes drug significantly lowered levels of blood sugar in patients and was free of serious side effects that have dogged a similar drug on the market, a new study found.
The study, released in Chicago at the annual meeting of the American Diabetes Association, could boost the prospects of what analysts say is one of the London-based drugmaker's most promising new drugs in development.
Merrill Lynch & Co. forecasts the drug, called Avandia, could generate $1.8 billion in sales by 2005 if it proves effective and safer than troglitazone, a drug invented by Sankyo Co. and licensed to Warner-Lambert Co. in the U.S. and Glaxo Wellcome Plc in Europe.
I think there's no question that it will be used frequently'' if its promise of greater safety holds true, said Barry Goldstein, a researcher on the SmithKline-sponsored study and head of the division of endocrinology, diabetes and metabolic diseases at Jefferson Medical College in Philadelphia.
SmithKline's Avandia is about 100 times as potent as troglitazone, Goldstein added, meaning doctors can prescribe less of it and lower the risk of potential side effects. In addition, Avandia works in a slightly different way, which also appears to lessen side effects compared to troglitazone, he said.
Both troglitazone, marketed by Warner-Lambert as Rezulin, and Avandia are members of a new class of oral treatments for so- called type 2 diabetes, the most common form of the chronic disorder characterized by the body's inability to properly regulate blood sugar levels. Type 2 diabetics make up the majority of the estimated 16 million Americans who suffer from diabetes.
While Rezulin is one of Morris Plains, New Jersey-based Warner-Lambert's strongest selling new drugs, reports of serious liver complications, including deaths, prompted the company to twice strengthen its warning label to patients. It advised doctors to closely monitor patients on the drug, which generated $420 million in sales last year.
London-based Glaxo halted sales of its version of the drug last year in the U.K. after at least five people died, although the company has said it plans to reintroduce the drug with a stronger label and monitoring requirements.
The Avandia study, which included 493 patients and took place over 26 weeks, found that the drug ''produces clinically and statistically significant lowering of blood sugar in type 2 diabetes patients,'' SmithKline said in a statement.
It said there have been no serious reported side effects, such as jaundice and liver failure, in patients taking the drug in any of its clinical trials. The drug, for which SmithKline expects to seek approval next year, has been tested on nearly 5,500 people to date.
Avandia, also known as rosiglitazone, ''appeared to be free of clinically significant side effects,'' SmithKline said. The most common side effects were respiratory infections and headache, the company said.
Patients were routinely monitored for blood enzyme levels that may indicate liver damage, similar to what is recommended for Rezulin, the company said.
Japan's Takeda Chemical Industries is also developing a new drug, known as pioglitazone, in the same class as the Warner- Lambert and SmithKline drugs. If approved, Indianapolis-based Eli Lilly & Co. will sell Takeda's drug in the U.S.
The interest by drug manufacturers is a mark of the promise of this group of drugs, which work by enhancing the body's sensitivity to insulin, Goldstein said. Insulin, a naturally occurring hormone, helps the body regulate levels of blood sugar.
16:26:10 06/14/1998 |
