The whimsical consumer campaign for Takeda’s insomnia drug Rozerem has generated lots of buzz, just not the kind of recognition that leads to new patient starts. That may be changing.

While the original goal of the effort, by Chicago’s Cramer-Krasselt and AbelsonTaylor, was to cut through the heavy spending by market leaders Ambien and Ambien-CR from Sanofi-Aventis and Lunesta from Sepracor, Takeda said it’s evolving the campaign to increasingly drive trials of Rozerem (ramelteon). According to the company, two new TV spots that debuted this year building on the  offbeat cast of dream-inspired characters have prompted more patients to actually mention Rozerem by name when discussing treatment options with their physician.

“In the very beginning, you find yourself as being, in the mind of the consumer, ‘You’re the product…with Abe Lincoln and the beaver,’” said Chris Benecchi, director of Rozerem marketing for Takeda Pharmaceuticals North America. “Now ‘Rozerem’ is coming through much more strongly.”

Indeed, Takeda would like to see its entrant in the $3.9-billion Rx insomnia category step out from behind its marketing shadow. The company says momentum is on its side. US marketing partner TAP Pharmaceuticals, whose reps joined forces with those of Takeda’s US subsidiary in touting Rozerem to doctors, became “really integrated” earlier this year, Benecchi said. Stronger personal promotion efforts, combined with the two new DTC executions, helped Rozerem post its second straight quarter of modest growth. First-quarter fiscal sales (April-June) doubled over the year-ago period to $30 million, Takeda said in a statement, following a sales jump of 78% or $26 million in the previous quarter.

While the fact that sales are on track to outpace marketing spend has been publicized this year, less highlighted has been the shift in campaign objectives. The plan involves continuing to leverage awareness. The two spots—called “Catch the Bus” and “Off to Work”—feature stronger brand mentions. Benecchi said more patients are able to ask for the drug by name, because awareness is high: “Brand linkage metrics, consumer awareness numbers have all steadily progressed over the life of the product.”

The advertising tweaks follow the introduction of generic Ambien in May, which will drive down the cost of zolpidem. Other challenges include internal management changes at Takeda. Benecchi is the brand’s latest marketing steward, a role he assumed after Paul Boidy departed earlier this year. Tim Rudolphi led the marketing from Rozerem’s 2005 professional debut up until the launch of the DTC campaign in July 2006. Takeda said the shifts are routine. But they illustrate the tricky task of ensuring that the new drug’s fresh and innovative promotional approach stays on track despite shifts in management.

Aggressive promotional outlays from the two branded rivals make Rozerem’s uphill slog even tougher. “We still see very, very massive investments in this market segment coming, for example, from Lunesta. And we feel as long as this continues, we have also to continue,” Hanspeter Spek, Sanofi-Aventis head of operations, said during a conference call last week.

Sepracor poured about $316 million into Lunesta DTC last year, while Sanofi-Aventis spent about $180 million promoting its sleep drugs to consumers, Nielsen Monitor-Plus figures show.
“We are promoting at a level that we feel is really the right spending point for us to go and have an effect,” said Benecchi.

But Tokyo must be feeling the cash burn. Expenses are eating into profits for the Japanese drug maker, which reported a 5.1% rise in net income in the most recent quarter, mostly thanks to higher sales of diabetes drug Actos. In a conference call with analysts, Takeda cited “steady support” for promotional activities including the DTC Rozerem campaign, support for which reached about $110 million last year, according to Nielsen Monitor-Plus.

One has to wonder whether the firm is growing impatient with the promotional effort, whose ROI in terms of revenue has been lackluster. Through June of this year, market share hovered at 3%, according to Verispan, compared to Lunesta’s 18%, and the 66% share owned by Ambien CR and Ambien. Datamonitor predicts Lunesta, Rozerem’s closest competitor, will cross the $1-billion sales threshold next year and increase its market share to 22%.

New prescriptions for Rozerem averaged about 196,000 a quarter through the first six months of the year, compared to 865,000 for Lunesta, according to Verispan, and more patients asking for trials alone won’t help close that gap. Rozerem is a unique, non-scheduled prescription medicine whose mechanism of action leads to a gentler sleep-inducing effect than other insomnia drugs. That means its maximum sleep-promoting response may not be felt until after several days or weeks of treatment.

While Rozerem’s recent moderate sales growth is encouraging, long-term success depends on physicians’ ability to identify appropriate patients and then convince new ones to stick with the drug.
This sleeping giant may be about to rouse, but it won’t happen overnight.