With the annual market for diabetes drugs expected to reach at least $25 billion worldwide by 2011, up from $15 billion today, drug makers have been investing heavily in new approaches to treating diabetes. And data presented at the American Diabetes Association's annual scientific conference last week suggested they are having at least some success.
One of the four treatments, Byetta, given by injection, is already on the market. Another, Exubera, an inhalable form of insulin, has been approved and will reach pharmacies next month. The other two, Galvus and Januvia, both taken as pills, are awaiting approval from the Food and Drug Administration, by early next year.
Byetta, introduced in June 2005, has stirred especially high hopes. The drug causes significant weight loss in many patients — in contrast to most existing diabetes treatments, which cause weight gain that can potentially worsen the disease. In addition, some data in animal studies hints that Byetta may help the pancreas regrow the cells that produce insulin, a crucial process in slowing the course of diabetes. Analysts are optimistic about the commercial prospects of all four of the drugs, forecasting that they will become blockbusters, with more than $1 billion in worldwide sales each. The new drugs will probably cost $1,500 to $2,000 a year per patient, more than existing treatments, analysts say. Injectable insulin typically costs about $1,200 a year per patient. Current diabetes drugs work by lowering blood sugar, either by sensitizing the body to insulin or by encouraging the pancreas to make more insulin. But over time, the conventional therapies tend to lose their effectiveness, and most patients must eventually inject themselves with insulin. That is why the new drugs, with their new approaches, are generating such interest.
Galvus, from the Swiss drug company Novartis, and Januvia, from Merck, raise the levels of a naturally occurring hormone that is released in the stomach and intestines during eating. The hormone, called GLP-1, causes the pancreas to produce more insulin while simultaneously discouraging the liver from producing sugar.Both Galvus and Januvia, which are sometimes called gliptins, appear to have few side effects and work well with existing diabetes drugs, according to papers presented at the A.D.A. conference. Galvus and Januvia do not appear to be quite as potent at lowering blood sugar as metformin, the existing first-line diabetes drug. But because of their mild side effects, they will probably be given as an adjunct to metformin,. Galvus and Januvia could have annual sales as high as $2 billion each.
T he fourth new drug is Exubera, Pfizer's inhalable insulin, which the F.D.A. approved in January and Pfizer plans to begin marketing this month. Insulin, the standard treatment for late-stage diabetes since the 1920's, is the most potent method of controlling blood sugar and is used by about five million Americans every day.
Dr.Vikram.K Source: Bionews
