Novartis is counting on Galvus, which some analysts say may generate $1 billion in annual sales, to compensate fo patent losses on older products such as the Lamisil antifungal. An ongoing delay in approval in the US has put Novartis far behind Merck and its Januvia pill, which is generating considerable prescription volume. Both drugs are part of a new class of diabetes meds known as DPP-4 inhibitors.
Novartis received an approvable letter for Galvus in February, which means the FDA is prepared to approve the drug, but some conditions must still be met. The agency is waiting for more safety data after skin lesions had been seen in monkeys and agency approval may not occur until 2010. But this is the third EU approval for Novartis in the past week. The other two - the Exelon patch for Alzheimer's and the Tasigna cancer med.