Novartis balks at Eylea-vs.-Lucentis data

Bayer and Regeneron ($REGN) are touting new data on their macular degeneration drug Eylea. And no wonder: The VIEW 1 and VIEW 2 studies found that Eylea matched rival drug Lucentis in head-to-head comparisons.

Approved in the U.S. in November 2011, Eylea is waiting for an OK from European regulators. It appears to be forthcoming; the European Medicines Agency's drug-review committee recommended it for approval last month, PharmaTimes notes.

But in the meantime, Novartis ($NVS) is striking back. The Swiss drugmaker, which markets Lucentis outside the U.S., questioned the new trials, saying that their dosing regimens didn't match actual treatment practices. "[I]t should be noted that the monthly dosing regiment of [Lucentis] used in these studies is not reflective of ... the way Lucentis is used in the 'real life' clinical setting," the company told PharmaTimes.

Novartis has a lot at stake. It's already faced with a low-cost competitor in the form of Avastin, the cancer drug used off-label to treat wet AMD. With Eylea on the market, at a price slightly lower than Lucentis's, Novartis could lose share, if U.S. sales are any indication.

Within 9 months of its launch in the States, Eylea had grabbed 13% of the wet AMD market, BioTrends Research Group said in a report. Regeneron is now projecting higher sales for the year than initially expected: $700 million to $750 million, compared with previous projections of $500 million to $550 million.

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