U.S. seeks more information on Novartis lung drug

A file photo illustration of pills of all kinds, shapes and colours, March 2003.

ZURICH (Reuters) - U.S. regulators have asked for more information on dosing proposed for a drug from Novartis AG for "smoker's lung," or chronic obstructive pulmonary disease, the Swiss group said on Monday.

Novartis said it would work with the Food and Drug Administration to review already submitted data for the drug, QAB149, as well as recently available data to determine what, if any, further clinical trials would be required.

"We think Novartis' attempts to build a respiratory franchise will only bear fruit once combination data and products are in the market, something that will not happen for many years," said Kepler Capital Markets analyst Tero Weckroth.

"From this point of view, a delay for QAB does not have a major impact on numbers," Weckroth said.

Novartis will initially sell QAB149 as a monotherapy. But industry analysts believe unlocking the medicine's full sales potential -- which some have put at $3-$5 billion a year -- will depend on combining QAB149 with other treatments.

Novartis is studying combinations with NVA237, a new drug it is developing with Vectura, and with Schering-Plough's inhaled steroid mometasone. Those combinations may not reach the market until around 2013, analysts estimate.

Novartis shares were trading flat at 51.95 Swiss francs by 3:38 a.m. EDT, versus a 0.5 percent rise in the DJ Stoxx European healthcare index. Vectura shares fell 3.2 percent.

QAB149, or indacaterol, is the first once-daily bronchodilator treatment for adult patients with COPD.

The European Medicines Agency recommended approval of the drug last month in a boost for Novartis' ambitions in respiratory medicine, a field currently dominated by GlaxoSmithKline, AstraZeneca and Pfizer.

"We are confident that Novartis will be able to address the FDA's dosing concerns over QAB149, particularly in view of the product's recent European approval," said PiperJaffray analyst Sam Fazeli.

(Editing by Mike Nesbit and Rupert Winchester)