Fox Business News
September 27, 2011
Novartis To File Lung Drug In Europe After Strong Trials
By Goran Mijuk
ZURICH - Novartis AG (NVS) on Tuesday said it will file experimental lung medicine NVA237 with European regulators in the wake of strong trial data, raising the odds that its lung-drug franchise will develop into a multi-billion-dollar business.
Novartis said data from two studies, dubbed GLOW1 and GLOW3, which will be presented at a meeting in the Netherlands, showed NVA237 significantly increased patients' lung function compared with a placebo, as well as improving exercise endurance.
Novartis said it will submit the drug for European Union approval under the brand Seebri Breezhaler for treatment of chronic obstructive pulmonary disease. A U.S. filing, analysts have said, is expected later this year.
Novartis' foray into the COPD market, which is expected to grow by 4.6% per year and reach a size of $13 billion by 2019, according to consultancy Decision Resources, could help the drug maker further broaden its portfolio, which includes specialty medicines, generic drugs and eye-care products.
COPD is currently managed using drugs that merely lessen its symptoms--dilating the airways and dampening inflammation to reduce wheezing, for instance--with no effect on the underlying disease or its progression. More than 210 million people are affected by the illness.
"These results illustrate the potential benefits of NVA237 for COPD patients," said David Epstein, division head of Novartis Pharmaceuticals. "[The results] are especially encouraging as we move ahead with plans to develop a fixed-dose combination with Onbrez Breezhaler," Epstein said.
Onbrez Breezhaler, which is also known as indacterol, used in combination with NVA237, could become a blockbuster if approved, analysts have said, putting a peak sale estimate at above $1 billion. However, issues surrounding the dosing of the combinational drug could delay or even thwart a potential market launch, analysts have warned.
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