Glaxo Is Testing Capsule-Based Inhaler Against Advair Diskus
February 10, 2012, 9:39 AM ESTBy Makiko Kitamura
(Adds comment from CEO in fourth paragraph.)
Feb. 8 (Bloomberg) -- GlaxoSmithKline Plc is testing a capsule-based inhaler, suggesting the U.K.’s biggest drugmaker is developing a cheaper version of its best-selling asthma treatment to compete with generic versions.
Glaxo completed a 60-patient, mid-stage trial in June comparing its Advair Diskus dry-powder inhaler against a capsule-based version of the drug-device combination, according to a posting on the clinicaltrials.gov website. A company spokesman couldn’t immediately confirm when a late-stage trial would begin.
The patent for Advair, also marketed as Seretide, will expire in Europe next year. The drug lost patent protection in the U.S. in 2010, though no generic versions have reached the market. Regulators call for rigorous studies of breathing- disorder medicines to show equivalence to older products, slowing competition. Glaxo has eight respiratory drugs in “advanced” development, Chief Executive Officer Andrew Witty told reporters yesterday.
“Our strategy has been to develop a broad respiratory portfolio of new products to add to Seretide,” he said.
A single-dose, capsule-based inhaler is less complex and less expensive than the Advair Diskus, and may be aimed at customers in emerging markets, Bloomberg Industries analysts said in a note today. The experimental product may also be targeting possible generic versions of Advair, such as VR 315, which is being developed by Novartis AG’s Sandoz unit and Vectura Group Plc, the analysts said.
Delayed Competition
Glaxo may face at least one generic competitor to Advair in the U.S. as early as 2016 and three or more equivalents in Europe over the next three to four years, Andrew Baum, an analyst at Citigroup Inc., said in a note to investors on Feb. 3. Possible competitors include Teva Pharmaceuticals Industries Ltd. and Sandoz, he said.
Advair and Seretide revenue totaled 5.06 billion pounds ($8.05 billion) in 2011, or a fifth of Glaxo’s global sales.
Glaxo will seek regulatory approval this year of Relovair, which the company is developing as a successor to Advair. Results from a late-stage study on the drug, which didn’t prove superior to Advair, disappointed investors on Jan. 9. Glaxo is investigating reports of fatal pneumonia from the highest doses.
--Editors: Kristen Hallam, Robert Valpuesta
To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
