Company Dreams of Waking Slumbering Pill’s Sales
CHICAGO _ When it comes to their sleeping pills, Americans want drugs that knock them out, despite the potential for dependency.
Just ask Takeda Pharmaceuticals North America Inc., which two years ago launched Rozerem as the first prescription anti-insomnia pill that is not a controlled substance. The sleep aid is barely making a dent in a $3.6 billion U.S. market.
So far Takeda is spending more annually on ads _ which feature a sleepless man, Abe Lincoln and a talking beaver _ than the drug is generating in revenues.
The troubles of Rozerem tell a rare story in the pharmaceutical industry of a brand-name pill, heavily marketed by television advertising, that has had lackluster sales. Takeda has spent $100 million annually advertising the drug as a safer alternative to top-selling prescription sleeping pills that come with warning labels about possible addiction. But Rozerem may have a problem because it does not have a sedating effect and is not as immediately effective as competitors.
“It will not knock them out and not necessarily give the greatest effect the first night that they take it,” said Dr. David Neubauer, associate director of the Johns Hopkins Sleep Disorder Center, who has been a consultant to Takeda and other makers of sleeping pills.
Ambien and Lunesta target benzodiazepine receptors that exist throughout the brain, triggering a deep sleep that tends to last seven to eight hours or more. However, the drugs also can trigger side effects that can lead to memory loss and balance issues, doctors say. Last year Rep. Patrick Kennedy D-R.I., named top-selling Ambien as part of the reason he became disoriented and crashed his car into a Capitol Hill security barricade.
Rozerem works completely differently from other sleeping pills by targeting melatonin receptors in the brain that are directly connected to the “sleep-wake” cycle. Because Rozerem is more specific, it has fewer side effects and induces a more normal sleep, the company and its studies indicate.
“Anybody who has taken Ambien, Lunesta, Sonata … they feel a sedating effect,” Neubauer said. “The major issue with Rozerem is that it is such a paradigm shift in relationship to everything that people have taken to improve their sleep in that virtually everything else is sedating. We seem to have a different mind-set when it comes to sleep medications.”
Rozerem has less than 3 percent of the U.S. market, according to industry sales figures. Ambien and its controlled-release version have about 77 percent of the market, and Lunesta, launched in 2005 just a few months before Rozerem, has about 16 percent of the market, according to IMS Health.
In the first quarter of this year, Takeda spent more than $40 million on Rozerem ads, TNS Media Intelligence figures show, and the company reported $26 million in sales during the same period.
Drug ads have been criticized for winning huge numbers of unnecessary prescriptions by putting the latest and typically most expensive brands into the hands of people who could be treated with a generic or over-the-counter medication. In the wake of Merck & Co.’s 2004 decision to pull the painkiller Vioxx from the market because of heart risks, studies showed that millions of Americans did not need the drug and could have been treated with over-the-counter pills like ibuprofen.
Rozerem’s lackluster sales come despite steps Takeda took to educate doctors before consumers were exposed to the drug. In the first year after the FDA approved Rozerem in July 2005, the company marketed to doctors so they were familiar with its differences from Ambien and Lunesta.
Takeda spent more than $90 million on TV and print ads last year for Rozerem, according to TNS Media Intelligence, including TV, print and billboards that center on the phrase “Your dreams miss you.”
The ads focus on the problem of insomnia and its next-day effects, and they are designed to play to the busy American who misses out on sleep because of work, stress and other issues, the company said.
Consumers are not convinced.
“The commercial is cute, but it is just not effective,” said Leslie Auerbach, 56, who has taken Rozerem. “If I am going on an overseas flight I take Ambien because I want to sleep. People I talk to know it works, and they want to be knocked out and they want a good night’s sleep.”
Some patients who take Rozerem have had difficulty maintaining sleep. Doctors and Takeda say Rozerem is an option for people who have difficulty falling asleep, or what sleep specialists refer to as “sleep onset” insomnia.
“It can help people fall asleep and stay asleep in the early part of the night,” Neubauer said.
But all is not lost. Sleep experts and Rozerem’s maker said the drug may take several weeks to have its greatest effect. Some compare it to anti-depressants, which are taken regularly but can take weeks before a patient sees results.
“We are patient and we know it takes time,” said Andy Hull, senior vice president of marketing at Takeda. “We think it is important to educate patients about a safer insomnia product.”
In new ads, created in a joint effort by Chicago-based agencies Cramer-Krasselt and AbelsonTaylor Inc., a man with insomnia bemoans to the fictional Abe Lincoln that he doesn’t “want to get hooked” if he uses a sleep prescription. “No worries,” Lincoln says. “There’s something different.”
Takeda would not comment on specific sales projections but expects to maintain the growth of its first quarter, when sales jumped 78 percent. In June, the company presented a study at a medical meeting in Minneapolis that showed Rozerem “does not affect middle of the night balance in older adults with insomnia.”
“These studies also showed that the patients’ memories were not affected by Rozerem the next morning,” said Gary Zammit, a psychologist and director of Sleep Disorders Institute in New York and a consultant to Takeda.
However, Rozerem has had its problems. In March the Food and Drug Administration ordered the makers of more than a dozen popular medications, including Ambien, Lunesta and Rozerem, to revise their labels to warn that the pills may cause users to drive, make phone calls, eat and even have sex while sleeping.
The FDA and outside medical experts who advise the agency said the incidence of such side effects were rare and not so severe that the drugs should be pulled from the market. Side effects also include difficulty breathing and other severe allergic reactions.
Rozerem also is up against an onslaught of ad spending by its rivals and a potentially cheaper version of Ambien, which recently became available in a generic form. In the first quarter of this year French drug giant Sanofi-Aventis, the maker of Ambien, spent about $45 million on consumer ads, largely for Ambien’s controlled-release version, while Sepracor Inc. spent more than $70 million for Lunesta, according to TNS Media Intelligence.
The drugmakers would not comment on the spending figures. Takeda, however, said it projects that sales will outpace spending this year.
Industry analysts have given Rozerem’s ads high marks for effectiveness in that market research studies show consumers are recognizing the ad and remembering the product, particularly given that Takeda is spending less than its rivals.
“This is a campaign that is getting a lot of criticism because it is unconventional, but it is one of the most memorable campaigns,” said Fariba Zamaniyan, senior vice president of IAG Research’s pharmaceutical practice. “From the functional ability to break through on television, it’s working on that perspective. The obstacle may be at the doctor’s office. … They are always going to be the gatekeeper.”
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