Novartis signals serious U.S. delay for blockbuster COPD program

Novartis's blockbuster plans to develop a game-changing combo COPD therapy for the U.S. market have run into a serious delay. The pharma giant noted today that investigators will need to come up with a fresh set of clinical data for NVA237--one half of the late-stage QVA149 program, which will now require new clinical studies--derailing its schedule on the much more important combo therapy.

That news cost its development partner, Vectura, a big chunk of its stock value. Analysts have estimated that an approval of the drug could open the door to a multibillion-dollar market.

Novartis ($NVS) unveiled the delay in its most recent quarterly report, worsening analysts' jitters that QVA149 is experiencing significant clinical issues. The other half of the combo treatment is indacaterol, which has won regulatory support at the low dose while running into opposition on the high dose, a potential issue for the next-gen trial work underway.

Michael King, an analyst with Nomura Code, tells Reuters' Ben Hirschler that he's worried the delay is due to a problem with the high dose. And depending on the exact type of data that Novartis will need to pursue in new studies, the developer could be looking at a two-year delay.

Interestingly, Novartis has experienced none of these issues in Europe, where it will file for an approval early next year. Novartis CEO Joe Jimenez did not say how long he expects the U.S. delay will last.

- here's the press release from Vectura
- get the story from Reuters

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