Novartis’s Seebri Drug More Effective Twice Daily: EMA

Novartis AG (NOVN)’s Seebri drug for smoker’s cough may be more effective when given twice a day, a finding that could put it at a disadvantage to Boehringer Ingelheim GmbH’s once-daily Spiriva lung treatment.

Information from a clinical trial suggests that taking 25 micrograms of Seebri twice a day may be better than taking 50 micrograms once a day, the European Medicines Agency said in an Aug. 1 assessment report. The document is the first time the details of the dosing study have been disclosed, Bloomberg Industries analyst Sam Fazeli said in a note published today.

The inhaled drug, which Novartis licensed from Vectura Group Plc (VEC) in 2005, may garner sales of $517.3 million by 2017, according to the average of three analyst estimates compiled by Bloomberg. While patients taking the medicine once a day may be more inclined to stick to the treatment, a twice-daily schedule may be safer and more effective, the agency said in its report. Seebri won approval in Europe as a once-daily treatment, Novartis said Oct. 1.

“The once-daily regimen has a clearly demonstrated efficacy and offers a benefit regarding patient compliance,” the agency said.

Optimal Dosing

The European agency has asked for an additional study in humans to find the optimal dosing schedule for the drug, according to the document.

“This may explain why the FDA asked for more trials,” Fazeli said in the note, referring to the U.S. drug regulator. GlaxoSmithKline Plc (GSK)’s umeclidinium also has data showing it may be better twice daily, he wrote.

The Swiss company said last year that marketing approval for the treatment in the U.S. would be delayed after the Food and Drug Administration requested more data on Seebri.

These new studies “will further explore the efficacy of once-daily Seebri Breezhaler as a COPD treatment and will also explore the efficacy of a twice-daily regimen of the same total daily dose,” Eric Althoff, a spokesman, said in an e-mailed statement.

Novartis is still developing the trial protocols and expects results of these studies three to five years after their approval, Althoff said.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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