Eli Lilly & Co. spent $128 million promoting Cymbalta (duloxetene) for the year through August, according to IMS Health. With an award-winning ad campaign and 70% sales growth in a cluttered category, the Hoosiers got their money’s worth, seeing $1.3 billion in 2006 sales and rating a 6-1 return on investment—virtually unheard of among top drug advertisers.

The SNRI won FDA approval  for major depressive disorder and diabetic peripheral neuropathy in 2004. Faced with a crowded market pitting it against the likes of Effexor, Zoloft, Paxil and Lexapro, and lacking a real point of differentiation beyond its pain indication, the Cymbalta team had to craft some standout advertising to break from the pack. DTC launched in October 2005, with unbranded work carrying the tagline “Depression hurts.”

“For us, the issues we were trying to address was that, despite the number of products approved over time and the progress made in understanding depression and making it more widely accepted, there was still a lot of stigma out there and a lot of people not getting the treatments they need,” says Monica Linde, manager of patient marketing for Neuroscience and an associate marketing consultant on the Depression Hurts campaign.

“So we were trying to think about what we could do to let sufferers who haven’t taken that step yet know that they don’t have to live life the way they’re living it if they can find the right treatment,” she says.

The campaign aimed to get viewers to look at depression differently. “We’re trying to bring to light lesser symptoms that people may not be aware of,” says Stacy Miller, consumer marketing manager for Cymbalta. “While people know about the classic symptoms, like sadness, loss of joy and fatigue, they’re less aware of the physical symptoms, like changes in weight, trouble sleeping and pain. It may not be as intuitive to think of this as part of mental illness.”

In April, 2006, Lilly switched to branded work, and the campaign has since gone through several iterations —the most recent of which emphasizes the way in which depression sufferers struggle to fulfill their daily obligations to their families and employers. “It’s about finding more accurate ways to help people recognize themselves, and helping them see that right now might not be as good as it gets,” says Miller.

Lilly’s messaging benefited from a broad range of market research techniques including focus groups, individual interviews and surveys.

In addition to TV, the campaign has included online advertising, with static and interactive banners using flash media, and national print, with a focus on titles aimed at women and a secondary concentration on entertainment news.

With Cymbalta maturing (the drug loses patent protection in 2011), Lilly is ratcheting down ad spend a bit (Q3 2007 spend was $26 million—down from $39 million for the quarter in 2006) and looking to maximize its profits from the franchise by adding additional indications for the drug— particularly its applications for pain. Cymbalta is the only antidepressant with a separate pain indication—for diabetic peripheral neuropathic pain, an indication it shares with Pfizer’s Lyrica. Lilly has filed for fibromyalgia, and is looking at Cymbalta’s potential in osteoarthritis and lower back pain. Last February, the drug was approved by FDA for generalized anxiety disorder, and in November, it got the OK for use as a maintenance therapy in patients with major depressive disorder.

Lilly has relied on the “Depression hurts” efforts to promote its GAD indication, since many symptoms are similar to those of depression, but has taken a more targeted approach to promoting its use for treating DPN pain, advertising heavily in specialty journals. But a 2005 mailer for DPN got the company in hot water with the FDA, which said in a warning letter that the promotion was “false and misleading” and omitted some of the most serious risk information associated with the drug. It was a rare black mark on an otherwise brilliant marketing effort.

From an ROI perspective, high marks must also go to Bristol-Myers Squibb/Otsuka’s Abilify, which saw an 8-1 return on their $53 million investment in promotion for the drug and saw a 23% gain in sales to $2.2 billion for the year through August, according to IMS Health. GlaxoSmithKline saw solid ROI for Lamictal and Avandamet for the same period. Last year’s MM&M large pharma team of the year, Vytorin, saw a 6-1 ROI on $128 million in advertising and promotion, with sales up 70% to $1.7 billion for the year through August, according to IMS Health data.

Roche’s Tamiflu garnered a respectable 4-1 ROI on a $16 million investment in its Happy Feet-themed Flu Facts campaign, one of the year’s most noteworthy creative executions and a first-ever movie tie-in for an Rx brand. Tamiflu saw sales up 28% for the year through August to $330 million over the same period in 2006.