National Editor

With one product awaiting FDA action in late February, Sepracor Inc. said Phase III data were positive with the hand-held inhaler version of Xopenex (levalbuterol nitrate), a short-acting beta agonist for asthma already sold for administration by way of a nebulizer.

"It's a different dosage form, and the two dosage forms do not cannibalize each other, which is attractive to us," said David Southwell, chief financial officer of Marlborough, Mass.-based Sepracor.

The company's stock (NASDAQ:SEPR) rose 84 cents Tuesday to close at $25.82.

Detailed data were not disclosed, but the company said that in each of three, large-scale pivotal trials, the drug was well tolerated and met the targeted efficacy endpoints in adults and children with asthma.

Using the primary airway function measure FEV1 - a test of lung function that measures air forcefully exhaled in one second - the inhaler form of Xopenex yielded statistically and clinically significant improvements relative to placebo (p<0.001).

"We haven't determined exactly where and when the [complete] data will come out," Southwell said, adding that they probably will be published closer to the drug's launch.

The development program for the more convenient, metered-dose inhaler includes more than 1,800 pediatric and adult subjects in 12 clinical studies, and all of the studies to be included in Sepracor's new drug application are finished. Sepracor targets the end of the first quarter of 2004 for an NDA filing.

The company's 450-person sales force markets Xopenex in vials for nebulizers to treat or prevent bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. Product revenues for the nine months ended Sept. 30 totaled about $186.6 million, up 50 percent from the same period last year. Market share of new prescriptions was about 26 percent at the end of the third quarter of this year.

Analysts have estimated the inhaler market as three times as large as the nebulizer market, which could mean $800 million more annually for Sepracor.

"We don't comment on projections," Southwell said, adding that the market-size estimates are about right if generic albuterol is taken into account. Otherwise, Sepracor puts the nebulizer market at $1.2 billion and the inhaler market at $1.5 billion.

The company has marketed nebulized Xopenex since 1999, Southwell said, selling $15 million that year, $190 million last year, and an expected $265 million this year.

"Nebulized albuterol is really cheap," he said. "But I've never heard anyone suggest that albuterol is better than Xopenex [a single isomer of albuterol]. A lot of patients prefer it, which is why we command the price premium that we do." Patients report fewer beta-mediated side effects, such as increased pulse rate and blood sugar levels, he said.

The inhaler also, "fortunately, uses a non-CFC propellant," developed by 3M Drug Delivery Systems, of St. Paul, Minn., Southwell said - thus avoiding concerns about the effects on the ozone layer of historically used chlorofluorocarbons. More than 60 million metered-dose inhalers are made by 3M each year. It's the device most commonly used by patients for the treatment of asthma and chronic obstructive pulmonary disease.

Still pending at the FDA is Estorra (eszopiclone) for insomnia. Estorra's NDA contains data from 324 clinical trials that included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. Six randomized, placebo-controlled Phase III efficacy studies, including one with a positive control, in chronic or transient insomnia were conducted in adult and elderly patients. (See BioWorld Today, Nov. 17, 2003.)

Last month, the FDA extended from Nov. 30, 2003, to Feb. 29, 2004, the action date as required under the Prescription Drug User Fee Act. Sepracor said the delay apparently was not related to questions concerning safety or efficacy, and would not have a material impact on the anticipated launch of Estorra in mid-2004.