Pfizer’s ability to reach what may be an untapped populationof people suffering from fibromyalgia got a boost last week when Lyrica becamethe first FDA-approved therapy for the condition.
Fibromyalgia,which the FDA says affects about 3 to 6 million people in the USannually, is viewed as an important indication. Some analysts say it could addas much as a billion dollars to sales. Now that the company can begin urgingpatients with the disorder to speak with their doctors about Lyrica—four months earlier thanexpected, thanks to priority review—it may place a bigger emphasis on DTC.
Pfizerdeclined to comment about its advertising plans. “There are several thingswe’re considering, but we haven’t made any firm decisions at this point,”a spokesman told MM&M.
Drivingawareness of the condition, whose symptoms can include debilitating pain, sleepproblems, stiffness and fatigue, is sure to be a key theme.
“Demandin fibromyalgia is something that will be more patient-driven thanphysician-driven,” observed Barbara Ryan, an analyst with Deutsche Bank. “Theability to advertise directly to consumers, at least in this particularindication, would be important.”
Whilethe FDA says there is no test to confirm a diagnosis, clear diagnostic criteriafor fibromyalgia were established in 1990 by the AmericanCollegeof Rheumatology. Awareness is low, however.
“Theissue is that a lot of physicians and patients themselves don’t actually knowabout those diagnostic criteria,” the Pfizer spokesman said. “Right now it’sbeen something that’s been discussed and taught about in the specialistcommunities but not necessarily in the broader primary care communities.”
Studieshave shown that some patients have decreased pain after taking Lyrica(pregabalin), but the mechanism by which the drug produces such an effect isunknown.
Pfizerplans to launch the indication to physicians in the third quarter but would notreveal its DTC timeline. The Lyrica consumer ad account resides with KaplanThaler, while Euro RSCG Life LM&P handles professional. Both declined tocomment.
Reachingconsumers won’t come cheap. In 2006, Lyrica’s first full year on the USmarket, Pfizer spent $27.5 million promoting the drug to consumers for itsother indications: nerve pain associated with diabetes and shingles, as well aspartial onset seizures. Lyrica was approved in late 2004 but didn’t launchuntil the following September due to a delay in getting classification from theDrug Enforcement Agency (the product is a controlled substance). According toNielsen Monitor-Plus, in the first quarter of this year, the DTC budget was$12.1 million.
Meanwhile,analysts are having difficulty sizing the market the new indication may openup, because they can’t gauge the extent to which existing fibromyalgia patientsalready were being treated with products like Lyrica that have painindications, or how much of Lyrica’s use had been for this population. Thus fardoctors have been treating it with a mixture of painkillers andantidepressants.
Lyricahad $1.2 billion in 2006 sales. Prudential analysts forecast $1.6 billion in USsales this year, growing to $2.7 billion by 2012. Deutsche Bank, for which Pfizer is an investment banking client, pegged 2008 earnings at $1.7 billionand thinks the fibromyalgia market alone could be worth another billiondollars.
“Weare at least forecasting [Lyrica] will have strong sales growth over the nextseveral years in the 20-40% range,” said Ryan, who had anticipated the newindication and so had already been factoring it into estimates. “We’ll have towatch the data.”
