Sepracor plans to double staff, launch ads

Sepracor Inc. plans to roughly double its workforce to about 2,000 people and launch a major advertising campaign after receiving a conditional approval from the US Food and Drug Administration for its new insomnia treatment, the Marlborough drug maker's chief financial officer said yesterday.

Sepracor said on Saturday it received an "approvable" letter from the FDA for the drug, Estorra, and that the agency hadn't requested additional clinical or preclinical trials while it considers final marketing approval, which the company said it expects by the end of this year and possibly sooner.

The National Institutes of Health estimates insomnia affects more than 50 million Americans, and treatment of the condition has become a hot area as drug makers bring to market new classes of pills.

Estorra will be an improvement on other treatments already marketed, such as Ambien and Sonata, because Estorra helps patients stay asleep and does not lose effectiveness over time, Sepracor said. In addition, the FDA's proposed label for Estorra will show the prescription pills can be taken for unrestricted periods, a fact the company likely will cite in a $60 million advertising campaign it plans to start after it receives final approval, said David P. Southwell, Sepracor's chief financial officer.

That will put Sepracor in direct competition with Sonata, made by King Pharmaceuticals Inc. of Tennessee and with France's Sanofi-Synthelabo Group, the producer of Ambien. Southwell estimates the current US market for the insomnia drugs to be $3.5 billion and growing as more people become aware of the available drugs. "Based on the way our drug will be positioned, we think there's no reason we can't get a leading share of this market," Southwell said.

Sepracor officials plan a conference call with investors today, but Southwell said the company doesn't plan to issue a new revenue forecast for the year pending final approval from the FDA. Currently the company's other products include an asthma drug sold mainly through hospitals and general practitioners, plus royalties it receives on antihistamines it has licensed to others, including Allegra and Clarinex. In 2003, the company lost $136 million on revenue of $344 million.

Sepracor plans a rapid expansion of its sales force to 1,250 people from 450 today, Southwell said, including 900 sales people marketing the drug to general practitioners. Including sales managers, total employment will rise to about 2,000 by the time of the product's expected launch later this year, from 1,000 today, he said, with employment in Marlborough increasing to 1,000 from 500 and the remainder spread across the country.

Ross Kerber can be reached at kerber@globe.com.