LONDON, Oct 25 (Reuters) - Two lung drugs being developed by Novartis a
nd its British partner Vectura face delays in the United States, the Swiss drugmaker said on Tuesday.
The news represents a significant setback for Vectura, the Swiss drugmaker's small partner, and shares in the British inhaled medicine specialist tumbled more than 20 percent in early trading.
NVA237, or glycopyrronium bromide, will require additional clinical data to support its U.S. submission and will consequently be delayed, Novartis said in an update with third-quarter results.
The changes to the NVA237 programme will also affect approval timing for QVA149, and additional clinical studies will be required for this product as well in the United States.
NVA237 helps patients with chronic obstructive pulmonary disease (COPD) in a similar way to a rival drug called Spiriva from Pfizer and Boehringer Ingelheim.
Novartis wants to combine it with another drug, indacaterol, to treat COPD, as it takes on market leader GlaxoSmithKline by developing a new kind of two-in-one medicine.
U.S. authorities have approved a 75 microgram dose of indacaterol, but Novartis failed to win backing for its higher 150 mcg dose.
Novartis gave no details about the issues delaying the two products, but the fact both NVA237 and QVA149 are affected suggests there could be a problem with the dose response, according to Michael King, an analyst with Nomura Code.
King said the need for additional clinical studies could add more than two years to the development programme, depending on the nature of the additional studies.
Novartis CEO Joe Jimenez told reporters he did not have an updated timetable for the two lung drugs.
In Europe, NVA237 has been submitted for approval under the brand name Seebri Breezhaler, and the target to submit QVA149 for approval remains on track for 2012 in Europe and the rest of world.
(Reporting by Ben Hirschler; Editing by Will Waterman) Keywords: NOVARTIS/VECTURA
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