Bayer's synthetic alpha glucosidase inhibitor, miglitol, has now been approved in its first market, the Netherlands, the firm told the Markeltetter. The Netherlands acts as the rapporteur for the rest of the Eurpean Union.
Miglitol will be probably not be launched by Bayer itself, which is seeking commercial partners for the drug, but depending on how negotiations go could be on the market before the end of the year or early next. A US approval is expected in 1997. The reason is that miglitol is a synthetic follow-up to Bayer's already successful Glucobay (acarbose), which is extracted from microorganisms. The drug has very similar properties to acarbose, according to Bayer.
After miglitol, subsequent approvals will include cerivastatin (formerly BAY W6228), a potent HMG-CoA reductase inhibitor for the treatment of hypercholesterolemia. The company filed for approval of cerivastatin in the USA, Europe and Japan in the summer, and optimistically expects to get clearance in at least one territory by year-end. Bayer has said that it intends to follow the example set by Sandoz with its fluvastatin product, and attempt to wrest market share from the established drugs in this class on grounds of price. The company has forecast sales of 700 million Deutschemarks ($463 million) at peak.
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