Sepracor Looking To Estorra DTC Ads To Wake Up Insomnia Market

Sepracor plans to spend $60 mil. on direct-to-consumer advertising for its insomnia agent Estorra in its first year on the market.

DTC advertising will be "a very important component" in Estorra promotions, CEO Timothy Barberich told analysts Sept. 25. "We're well positioned financially to grow the sales force and to spend probably about $100 mil. in marketing expense for the first 12 months of the product, of which $60 mil. will be [DTC] marketing."

Barberich characterized the insomnia market as "a market that is looking for a drug to help it grow."

The eszopiclone NDA was submitted Jan. 31 for treatment of transient and chronic insomnia; the firm expects to hear from FDA on Dec. 1, the first weekday following the user fee goal date.

Sepracor plans to increase its sales force from 450 to 1,250 reps to market Estorra. The additional reps will include a hospital team, "because there's a lot of comorbidity between insomnia and pain," Barberich said. "We'll also have about 100 reps detail psychiatrists, because there's comorbidity between insomnia and anxiety and depression." The remainder of the sales force, approximately 900 reps, will concentrate on primary care.

"If you look at this on a product detail equivalent basis, we expect to have at least as many as any competitor that will be on the market for the next few years," Barberich maintained.

Pfizer and Neurocrine Biosciences are planning to use about 1,000 reps for their upcoming insomnia agent, indiplon. The product, which is targeted for NDA submission in early 2004, will be promoted by 800 Pfizer GP reps and a Neurocrine specialty sales team of 200 (see ¹ (Also see "Pfizer/Neurocrine Indiplon Looking For First Sleep Interruption Claim" - Pink Sheet, 1 Oct, 2003.)).

By targeting psychiatrists, Sepracor is hoping to capture some of the off-label insomnia market; sedating antidepressants, such as trazodone, are commonly used. "That's certainly a market that we want to go after," Barberich noted.

Sepracor is stressing long-term use and sleep maintenance as advantages over Sanofi-Synthelabo's Ambien (² (Also see "Sepracor Estorra NDA Includes Data For Sleep Maintenance, Long-Term Use" - Pink Sheet, 1 Feb, 2003.), p. 10).

"We've demonstrated that we put patients to sleep quickly, we keep them asleep for a long time, we achieve sleep maintenance in all of our studies, there are no next-day residual effects the next morning, no hangover and no tolerance, rebound or withdrawal effects," Barberich stated.

"We've completed a six-month or one-year study, depending on whether you look at it as a blinded study or an open label," he added. "Hopefully we can use that to market the drug as a drug that doesn't have a restriction on the amount of time it can be used."

The study demonstrated statistically significant improvement in sleep onset with no reduction in efficacy over time. "That shows that [Estorra] doesn't wear off over time and it works consistently over a long period of time," Barberich said. Similar results were seen for total sleep time and wake time after sleep onset.

Promotional efforts will also likely stress quality of life benefits, particularly the lack of next-day residual effects seen with older sleep agents.

Sepracor presented recent data showing that eszopiclone significantly reduced the number of naps and duration of daytime naps versus placebo (p<0.03 and p<0.005) in elderly patients who took naps during a two week study. Barberich maintained that naps were "perhaps a more objective measurement" of next-day effects.

The quality of life benefits were carried over into significant improvements in daytime alertness (p<0.03) and sense of physical well-being (p<0.05). "Results of this study also showed a trend towards significance in improved daytime ability to function and reduced morning sleepiness (p=0.06 for each)," the firm said.

Data from the 231-patient Phase III double-blind, placebo-controlled trial were presented at the International Congress of the International Psychogeriatric Association in Chicago Aug. 22. Significant results were also seen in sleep maintenance endpoints (wake time after sleep onset, sleep onset and total sleep time).

Sepracor will continue to present eszopiclone data at medical meetings and has several publications planned throughout the year.