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Monday November 13, 5:58 PMNovartis diabetes drug delayed in U.S., shares fallZURICH, Nov 13 (Reuters) - A U.S. decision on approving Novartis AG's key diabetes drug Galvus has been delayed by three months after the firm asked the Food and Drug Administration to consider new clinical trials data, sending its shares sharply lower.Novartis said on Monday the FDA would examine new data, which provide evidence that skin problems in a preclinical animal study have not been seen in clinical studies with patients treated for Type 2 diabetes. "It was our decision," said Novartis spokesman John Gilardi. "It's a setback but we're still confident of getting it to the market quickly." The move leaves the Swiss group lagging U.S. rival Merck & Co. Inc. in the race to launch a new class of diabetes drugs, known as DPP-4 inhibitors. Merck's Januvia was approved last month. Novartis shares were down 1.6 percent at 72.55 euros at 0955 GMT, after opening 10 percent lower and being briefly halted. Galvus is one of three blockbuster hopes in the Novartis pipeline of new drugs, along with Tekturna and Exforge for hypertension. The FDA review period for Galvus, an oral drug, has been extended from end-November until the end of February 2007. "If the only thing is a three-month delay, obviously it's not all that serious, but they're highlighting a safety issue that they had not published before so that's new to the market," said Kepler Equities analyst Denise Anderson. "It certainly increases the risk profile of the drug," Anderson said. "It does increase the risk of an even longer delay." BILLION-DOLLAR OPPORTUNITY Novartis still hopes to launch Galvus next year in the United States, but some investors fear it will now lose the first-mover advantage to Merck. Both Galvus and Januvia have been touted by analysts as potential $1 billion-a-year-plus sellers and the new DPP-4 inhibitors are expected to compete intensely in the lucrative market of oral treatments for diabetes. They are designed to enhance the body's own ability to lower elevated blood sugar and could become an important new way to control Type 2 diabetes -- the most common form of the disease, which is becoming a major health crisis around the world. Analysts believe DPP-4 drugs are likely to become popular in the market for oral diabetes treatments, since they are not associated with weight gain, a major side effect of established diabetes drugs known as TZDs. That is significant as most Type 2 diabetics are overweight or obese. When patients gain weight from medicines they often stop taking it, and patient compliance is considered one of the biggest obstacles in diabetes treatment. The two leading brands of TZDs which could be hit by the new DPP-4 competitors are Actos, from Takeda Pharmaceutical Co., and Avandia, sold by GlaxoSmithKline. Diabetes, which is linked with obesity, affects about 195 million people worldwide and the number of sufferers could top 330 million by 2025, according to the International Diabetes Federation. (Additional reporting by Ben Hirschler in London) |
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