National Editor

Nearly tripling its in-house sales force to launch its insomnia drug Estorra, Sepracor Inc. is ending its co-promotion deal with the Ross Products division of Abbott Laboratories for the asthma therapy Xopenex.

Sepracor's stock (NASDAQ:SEPR) closed at $46.57, up $1.22.

Wall Street probably wasn't surprised by the news, since Marlborough, Mass.-based Sepracor disclosed its plan for the bigger sales team earlier this month, when the FDA's approvable letter arrived for Estorra - an event that boosted Sepracor's stock price more than 56 percent to close at $44.30.

"It's a close race [in the insomnia field], but Sepracor's definitely pulling ahead," said Heather Martin, analyst with the research firm Decision Resources in Waltham, Mass.

The Ross arm of Abbott Park, Ill.-based Abbott sells Xopenex to pediatricians in the U.S. in exchange for a commission, and Sepracor's crew promotes the drug to that sector, too, as well as to allergists, pulmonologists and primary-care physicians. With Sepracor's expansion of the 450-person sales force to about 1,250, the Ross deal is hardly needed.

Residual payments to Ross from Sepracor will total $30 million by the end of 2005, with another $3 million due by the end of 2006. Nebulized Xopenex (levalbuterol nitrate), a short-acting beta agonist indicated for bronchospasm caused by reversible obstructive airway disease, sold about $286.8 million in 2003, 51 percent more than the previous year's sales.

Sepracor is putting together a new drug application for the Xopenex hydrofluoroalkane metered-dose inhaler, which is hand-held. Several Phase III trials yielded positive results with the inhaler used by adults and children. (See BioWorld Today, Dec. 3, 2003.)

Meanwhile, Estorra (eszopiclone) is formulated in 1-mg, 2-mg and 3-mg tablets for various forms of insomnia in adult and elderly patients. Insomnia has been a hot indication lately, with positive Phase III data coming down the pike earlier this week from would-be Sepracor competitor Neurocrine Biosciences Inc., of San Diego. (See BioWorld Today, March 25, 2004.)

NBI has indiplon, a non-benzodiazapine agent that acts on a specific site of the GABA-A receptor, which is vying - along with Estorra, also in the new class of non-benzodiazepines - for a piece of the insomnia market now largely held by Paris-based Sanofi-Synthelabo SA's Ambien (zolpidem). Another drug on the market is Sonata (zaleplon) from King Pharmaceuticals Inc., of Bristol, Tenn.

New drug applications are expected by the middle of this year from NBI and partner Pfizer Inc., of New York, for the immediate-release formulation and for the modified-release version of indiplon.

Martin predicted indiplon will "eventually have more sales. [NBI] has the backing of Pfizer and their marketing power will drive it that much farther." She is preparing a report on sleep disorders for Decision Resources, due for release in late April.

Both drugs claim to have overcome the hangover drowsiness that bedevils many users of the approved insomnia therapies, although how they stack up against each other in that regard likely will not be known until later, Martin said.

"They're both going to be taking shares away from Ambien, but their safety results are pretty average, and nobody really showcases the downsides," she said. "It's tough to tell."