Iskowitz, Marc

With three launches in the space of six months, nobody’s resting easy in the $2.1 billion insomnia market. Sanofi-Aventis is looking to defend Ambien’s turf, while Sepracor’s Lunesta and Takeda’s Rozerem aim to put on share and seek footholds in a suddenly crowded market. Marc Iskowitz reports.

The market for anti-insomnia drugs has all the stuff of a Hollywood thriller: a David-vs.-Goliath story, edge-of-the-seat drama and a cast of thousands.

Sanofi-Aventis hopes to restore some youthful vigor to its blockbuster category-leader Ambien (zolpidem) with a new extended release formula. The franchise’s long reign is being challenged by Lunesta (eszopiclone) from Sepracor. Enter Rozerem (ramelteon), another player with a completely new mechanism of action from Takeda Pharmaceuticals North America.

The three new drugs debuted within six months of each other, starting with the April launch of Lunesta, which employed a simultaneous consumer and professional campaign. Rozerem made its professional debut in September, followed by an Ambien CR physician education campaign last month.

Analysts estimate that the three have serious potential to either grow the market or sap share from incumbent Ambien, which leads and has largely fueled the $2-billion prescription anti-insomnia category. The sleep field has proven a fast-growing one in recent years, jumping 20 percent in total sales from 2003 to 2004,22 percent from 2002 to 2003, and 26 percent from 2001 to 2002, according to IMS Health (Fig. 1). Similarly, new prescriptions have come at a quick pace, increasing eight percent 2003 to 2004, eight percent 2002 to 2003, 12 percent 2001 to 2002 and 11 percent 2000 to 2001.

Some 70 million Americans suffer from insomnia, according to the National Institutes of Health. But only three million Americans are actually on prescription medication for it. “There seems to be a huge disconnect between the number of those with the condition and those seeking prescription treatment from their physicians,” Rozerem product manager Tim Rudolphi told MM&M.

Though dwarfed in both size and time-to-market by Sanofi-Aventis, Takeda feels confident in its new entrant, which could benefit from a unique selling proposition. Rozerem is not scheduled as a controlled substance and thus does not lead to addiction. “Our whole campaign is really based around the fact that we had zero risk of abuse and dependence,” Rudolphi says.

Lunesta also is approved for long-term use, despite being classified as a controlled substance. Though also a controlled substance, Ambien CR is not limited to short-term treatment like original Ambien and so may better navigate abuse concerns than its predecessor or Lunesta.

Rozerem’s mechanism of action differs, too. Instead of working with a natural brain chemical called GABA, like Lunesta and Ambien, Takeda says Rozerem flips a switch in the brain’s “master clock,” or suprachiasmatic nucleus (SCN).

Sanofi-Aventis’ brand team is Grafting its own communication strategy built on 17 years’ experience. “We know the market, we know what patients want and what physicians are complaining about the most,” says Corinne Le Goff, Sanofi-Aventis vice president of marketing for CNS products. “That’s why we developed Ambien CR.”

The drug maker hopes to switch many Ambien users to the controlled release version by pitching it to doctors as a more “complete solution” Le Goff says. She anticipates 30-50 percent of Ambien patients will make the switch. Brand communications will emphasize Ambien CR’s indication for sleep maintenance, in addition to sleep induction. “When you have three patients with insomnia, two of them have maintenance problems,” Le Goff says. “Sleep induction represents [only] a fifth of insomnia problems.”

But with a host of potential rivals waiting in the wings, including Pfizer’s indiplon, Merck’s gaboxadol and Somaxon’s Silenor (doxepin), Sanofi-Aventis has its work cut out for it. Ambien’s 82.6 percent market share, based on sales activity through August (Fig. 2), is roughly eight percent off its 2004 end point of 89.9 percent.

Some of the missing share may have gone to Lunesta. In April, its first month on the market, the drug stunned analysts by seizing a 15.3 percent share, compared to Ambien’s 76.5 percent. Performance then dipped before cresting to 14.8 percent market share for August. Ambien hovered close to 80 percent throughout.

All told, Lunesta achieved an 8.6 percent share for Sepracor over its first five months, data from IMS Health show, ringing up $144 million in sales. That pales in comparison to Ambien’s $1.1 billion over the same period, but it proved enough to edge out several older drugs, including Sonata (zaleplon) from King Pharmaceuticals and Restoril (temazepam) from Mallinckrodt Pharmaceuticals (Sepracor could not be reached for comment on this article).

The drug’s innovative launch campaign featured an integrated consumer and professional effort by McCann HumanCare and sister agency Echo Torre Lazur. It also included aggressive consumer marketing tactics of the sort since shunned by the industry, with a DTC ad blitz including teaser spots.

By contrast, the Rozerem brand team will take an approach in line with PhRMA’s Guiding Principles on DTC Advertising, holding off on deploying DTC ads until the first half of 2006, Rudolphi says. For now, Takeda’s 1,000 U.S. field reps are focusing on educating clinicians about Rozerem’s unique mechanism of action, safety profile and in identifying appropriate patients.

“We certainly think that DTC could play a role in this condition and obviously then with Rozerem.” Rudolphi says. “But before we get there, it’s more important for us to ensure that healthcare providers fully understand the benefits of Rozerem, where it works, who it works with.”

Takeda marketers have expressed skepticism of mass-market DTC efforts like Lunesta’s. This summer, Richard DaIy, Takeda senior vice president, marketing, told MM&M: “There’s a tremendous opportunity for education on sleep, but the market isn’t growing (MM&M, August 2005).” However, the firm is working on a consumer campaign with Chicago’s Abelson-Taylor that includes patient education materials for physician offices and waiting rooms.

Sanofi-Aventis is going out with an as-yet unscheduled DTC campaign for Ambien CR, working with Publias’ Saatchi & Saatchi family of agencies on med ed, consumer and professional ads.

The firm will use the tried-and-true category defender’s strategy of emphasizing the brand’s trusted name. “We are the leaders, so we will behave as leaders,” Le Goff says.

Copyright Haymarket Media, Inc. Nov 2005

Provided by ProQuest Information and Learning Company. All rights Reserved