If unbranded direct-to-consumer ads in support of Pfizer’s Lyrica for fibromyalgia moved the needle on prescriptions, branded creative could boost uptake even more.

That’s what Pfizer is hoping as the DTC campaign for Lyrica evolves to include new TV and print work that mentions the drug by name.

Fibromyalgia is a syndrome characterized by widespread muscle pain andfatigue that until relatively recently had no diagnostic criteria and no approved treatments. Now, in addition to Lyrica (pregabalin), the FDA is set to decide on Eli Lilly’s Cymbalta infibromyalgia on or before June 2008, while Forest Labs and Cypress filed milnacipran for thatindication on Dec. 31st. Two other compounds are inlate-stage clinical development. New therapies are expected to grow the fibromyalgia market from under $400 million in 2006 to $2 billion by 2016, Datamonitor predicts.

The disease is hindered by a lack of awareness andunderstanding, though, with over 50% of patients undiagnosed.

“This is almost a textbook definition of an unmet medicalneed,” said Ian Read, VP,president of Pfizer Worldwide Pharmaceutical Operations, during a conference call with analysts last September.

DTC promotional spending on Pfizer’s Lyrica

July-Sept. 2007 $9,205,322
April-June 2007 $18,145,127
Jan.-March 2007 $12,095,235
Total $39,445,684
Source: Nielsen Monitor-Plus, Dec. 2007

That’s where DTC comes in. Ad campaigns for Rx drugs often follow a well-trod path, and Lyrica’s is no exception. Unbranded outreach began over the summer with an awareness effort with the NationalFibromyalgia Association (NFA). PSAsfeatured people who suffer from fibromyalgia speaking about theirexperience with the disorder and a call to visit a Web site,www.fibrohope.org, for more information.

Introduced in the fall, branded DTC spots touting Lyrica for fibromyalgia(pictured upper left) are running on TV and online at Lyrica.com. Print ads appear in Newsweek.The branded spots employ basically the same messaging as the unbrandedones. The Lyrica push was part of a 2007 DTC surge by the drug makerthat also saw debut ads for new smoking cessation aid Chantix, as wellas new TV spots for ED drug Viagra and painkiller Celebrex.

“I find the whole transition from unbranded to branded to be veryfascinating. When you see brands do it, it generally means they’re verysuccessful,” said Jim Joseph, EVP manging director, Saatchi & SaatchiConsumer Health + Wellness, a unit of Publicis. “[Pfizer is] following that classic curve, which means the marketing isworking.” That is, if its condition-awareness efforts weren’t resonating, the branded ads may have been delayed, or initiated sooner.

Indeed, Pfizer has seen a greater number of new and total patient prescriptions following the June approval forfibromyalgia, launch of Lyrica for that indication in July, and initiation of the unbranded DTC work, noted Bear Stearns analystJohn Boris in an investor note last month. As of Dec. 14, Lyrica hadposted new and total prescriptions (NRx’s/TRx’s) of 118,871 and 203,737,respectively. While that was slightly lower that the previous week’s totals of122,509 and 211,988, Boris said he was impressed with the data points’ upwardtrajectory over the previous four weeks.

The unbranded Lyrica program is still running, an NFA spokesperson said. Keeping both on is another classic strategy. “The truth is, different strategies appeal to different consumers,” Joseph said.  “Some consumerswill be more drawn to an unbranded piece and others more drawn to a brandedpiece because it’s a little more tangible. At the end of the day, though, they build on each other when you have two forces in the marketplace working intandem. You can expect the sales to continue, maybe even at an acceleratedrate.”

He likened the situation to the campaign for Merck’s HPV vaccine Gardasil, whose unbranded messaging was not so different from its branded messaging, either. “[Gardasil] sawexplosive growth after [Merck] launched the branded campaign, because the two builton each other.”

For the 12 months ended November 2007, Lyrica US revenue topped $965.8 million, according to Verispan. The drug was approved in 2006, initially for treating nerve pain associated with diabetes and shingles, as wellas for partial onset seizures. In the third quarter of 2007, sales grew 37% to $465 million, compared to the sameperiod the year prior.

Fibromyalgia, which affects some three-to-sixmillion people in the US, is expected to triple the number of USpatients who can benefit from Lyrica, Pfizer has said. The company is also testing the drug in general anxiety disorder, key data for which are expected in 2009. Datamonitor estimates Lyrica fibromyalgia salescould grow to $641 million in 2016, making it the market leader. That could help Pfizer staunch some of the losses anticipated from the looming sunset of patent exclusivity for the firm’s bestselling-drug, the cholesterol-lowering drug Lipitor, in the 2010-2011 timeframe.

Which is why analysts are watching Lyrica closely. Pfizer did not return a call seeking comment on the ads. Kaplan Thaler handles the Lyrica consumer ad account,while the professional business resides with Euro RSCG Life LM&P.

Accordingto NielsenMonitor-Plus, through the first three quarters of the year Pfizer had spent nearly $40 million promoting Lyrica to consumers. Since ad spend is reported once the ads run, according to Nielsen, Pfizer’s fourth-quarter spending on Lyrica was expected to increase over the amount spent during the prior three-month period (see chart). Its spending on Lyrica DTC promotion reached $27.5 million for all of 2006.