Pfizer's ability to reach what may be an untapped population
of people suffering from fibromyalgia got a boost last week when Lyrica became
the first FDA-approved therapy for the condition.
which the FDA says affects about 3 to 6 million people in the US
annually, is viewed as an important indication. Some analysts say it could add
as much as a billion dollars to sales. Now that the company can begin urging
patients with the disorder to speak with their doctors about Lyrica—four months earlier than
expected, thanks to priority review—it may place a bigger emphasis on DTC.
declined to comment about its advertising plans. "There are several things
we're considering, but we haven’t made any firm decisions at this point,"
a spokesman told MM&M.
awareness of the condition, whose symptoms can include debilitating pain, sleep
problems, stiffness and fatigue, is sure to be a key theme.
in fibromyalgia is something that will be more patient-driven than
physician-driven," observed Barbara Ryan, an analyst with Deutsche Bank. "The
ability to advertise directly to consumers, at least in this particular
indication, would be important."
the FDA says there is no test to confirm a diagnosis, clear diagnostic criteria
for fibromyalgia were established in 1990 by the AmericanCollege
of Rheumatology. Awareness is low, however.
issue is that a lot of physicians and patients themselves don’t actually know
about those diagnostic criteria,” the Pfizer spokesman said. “Right now it’s
been something that’s been discussed and taught about in the specialist
communities but not necessarily in the broader primary care communities.”
have shown that some patients have decreased pain after taking Lyrica
(pregabalin), but the mechanism by which the drug produces such an effect is
plans to launch the indication to physicians in the third quarter but would not
reveal its DTC timeline. The Lyrica consumer ad account resides with Kaplan
Thaler, while Euro RSCG Life LM&P handles professional. Both declined to
consumers won’t come cheap. In 2006, Lyrica’s first full year on the US
market, Pfizer spent $27.5 million promoting the drug to consumers for its
other indications: nerve pain associated with diabetes and shingles, as well as
partial onset seizures. Lyrica was approved in late 2004 but didn't launch
until the following September due to a delay in getting classification from the
Drug Enforcement Agency (the product is a controlled substance). According to
Nielsen Monitor-Plus, in the first quarter of this year, the DTC budget was
analysts are having difficulty sizing the market the new indication may open
up, because they can’t gauge the extent to which existing fibromyalgia patients
already were being treated with products like Lyrica that have pain
indications, or how much of Lyrica’s use had been for this population. Thus far
doctors have been treating it with a mixture of painkillers and
had $1.2 billion in 2006 sales. Prudential analysts forecast $1.6 billion in US
sales 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 billion
and thinks the fibromyalgia market alone could be worth another billion
are at least forecasting [Lyrica] will have strong sales growth over the next
several years in the 20-40% range,” said Ryan, who had anticipated the new
indication and so had already been factoring it into estimates. “We’ll have to
watch the data.”