An executive familiar with initial plans said the product's first-year marketing budget could exceed $50 million.
`97 APPROVAL AT EARLIEST
Roche's orlistat, to be marketed under the name Xenical, isn't due for a ruling on final Food & Drug Administration approval until next year at the earliest. But with medical treatment taking center stage for the first time in 20 years in Americans' battle to lose weight, Roche wants to be ready with an aggressive marketing plan.
The company named Lowe & Partners/SMS and its sister units Lowe Direct and Lowe McAdams Healthcare, all New York, to handle the launch after a shoot-out with FCB/Leber Katz Partners, FCB Direct and FCB Healthcare.
"This is one of Roche's most important products. There's a huge untapped market," said Maryann Kuzel, marketing director-metabolic products for Roche.
Some 50 million Americans are clinically obese, or 20% above ideal body weight.
ONLY SECOND OF ITS KIND
Xenical could become only the second prescription drug approved to treat obesity in the past 20 years. The first, Redux from American Home Products Corp.'s Wyeth-Ayerst division, was approved in April and has gotten off to a fast start.
Industry analysts said that in only five years it could reach $1 billion in sales-about as much as U.S. consumers now spend annually on diet aids such as shakes and over-the-counter pills.
Although some experts have been waiting for a major marketing effort for Redux, Wyeth-Ayerst recently said it plans only an obesity education campaign. Klemtner Advertising handles medical advertising.
Roche has concluded clinical testing on Xenical and plans to file summaries of the tests to the FDA in late November. The company hopes to get marketing approval early next year, at which point it would begin campaigns aimed at medical professionals, managed-care organizations and consumers.
Approval isn't guaranteed, of course. An FDA advisory panel recently recommended against approving sibutramine, a Knoll Pharmaceuticals drug somewhat similar to Redux, because of concerns about high blood pressure.
SAME AIM, DIFFERENT METHODS
Xenical and the other new drugs share the same basic aim: to help obese people lose weight and keep it off. But each works differently.
Redux affects users' brains, limiting the urge to eat. Effectiveness declines after about six months. Xenical works on the body's digestion, blocking absorption of about a third of the fat in a person's diet. People using Xenical only need to take it with meals that include fat, and can take it forever if necessary.
"Patients on Xenical lost 65% more weight than panelists [not taking the drug but] on a well-balanced diet," said Philippe Burnham, brand director at Roche, who added that Xenical is the only one of the new obesity drugs to have completed two-year clinical trials.
For Lowe, Xenical is a big win. The agency bought the McAdams healthcare unit this year and beefed up Lowe Direct with some new hires this summer. Co-Chairman Marvin Sloves said the agency wouldn't have won without the three-pronged team effort.
Contributing: Michael Wilke.