Sepracor Inhaler Reduces Asthma Symptoms in Trials

Sepracor Inc. said on Tuesday its new, pocket-sized inhaler reduced symptoms of asthma in late-stage clinical trials, and it plans to file an application for marketing approval in the first quarter of 2004.

Sepracor Inc. said on Tuesday its new, pocket-sized inhaler reduced symptoms of asthma in late-stage clinical trials, and it plans to file an application for marketing approval in the first quarter of 2004. The Xopenex HFA metered-dose inhaler is a more convenient version of Sepracor’s existing Xopenex nebulizer. The inhaler is a hand-held device, compared to the large, non-portable nebulizers that are used mainly at home or in hospitals. The company said the new inhaler met the main goal of its three Phase III trials, producing a statistically significant reduction in symptoms of asthma relative to a placebo. If approved, the drug could substantially expand the company’s market for asthma treatments, as it can easily be carried in a pocket or purse by asthma sufferers. “You can just put it in your pocket and take a puff,” said Ken Wahl, an analyst at Mehta Partners, who said Sepracor is steadily building a portfolio of respiratory drugs. The company is expected to seek approval next year for another asthma drug, an altered form of Foradil, sold by Novartis AG . “This inhaler is more than just a line extension,” Wahl said. “It’s a real improvement on the existing product.” Sepracor’s shares rose 98 cents, or nearly 4 percent, to $25.96 in mid-morning trading on Nasdaq. David Southwell, the company’s chief financial officer, said the inhaler won’t cannibalize Sepracor’s nebulizer sales, which topped $186 million in the first nine months of this year. “These are very different markets,” he said. “A lot of patients prefer the nebulizer, they find it works better. But it is important for us to have an MDI inhaler if we’re going to cover the whole waterfront. The MDI market is substantially larger than the inhalation market.” Xopenex competes mainly with a generic drug called albuterol. Xopenex is considered better than albuterol and analysts expect combined sales from the nebulizer and inhaler to reach as much as $750 million. Sepracor is planning to manufacture the inhaler in partnership with 3M Co., which makes many of the inhalers commonly used to treat asthma and chronic obstructive pulmonary disease. 3M will receive a royalty on the product. Analysts are also keenly awaiting U.S. regulators’ decision on whether to approve Sepracor’s experimental sleeping drug, Estorra, a modified version of a drug sold in Europe. (Source: Reuter’s Health, Toni Clarke Yahoo Health News, December 2003)