Lipitor loses out on Alzheimer’s lifeline
pharmafile | April 22, 2008 | News story | Research and Development |Â Â Â
Pfizer's blockbuster statin Lipitor has shown no impact on the treatment of Alzheimer's disease, scotching the company's hopes for a potentially lucrative licence extension.
Lipitor is the world's best-selling anti-cholesterol treatment, but it is just three years away from losing patent protection and Pfizer had hoped it could also be used to treat Alzheimer's.
The company carried out the largest ever study into the effects of a statin on the disease, but the LEADe trial found adding Lipitor to treatment with Pfizer's Alzheimer's drug Aricept had no significant impact.
The trial examined patients with mild-to-moderate Alzheimer's disease, comparing treatment with Lipitor (atorvastatin) 80 mg and Aricept (donepezil) 10 mg to a treatment of placebo plus Aricept 10 mg.
The trial showed no significant differences in cognition or global function (key measures of Alzheimer's progression) and no statistically significant differences were seen on various cognitive, behavioral and functional secondary endpoints.
Statins have been suggested as potential treatments for the neuro-degenerative disease for some time, but firm evidence on their efficacy has been hard to come by and in the last year two other trials have come to conflicting conclusions.
In July 2007 an observational study of a number of statins found simvastatin to be associated with a reduced incidence of dementia, Lipitor had only modest benefits.
The LEADe trial, as the most authorative study to date of a statin in Alzheimer's, could now close off this avenue of research.
Its results come at a difficult time for Lipitor which, although still the world's best-selling statin, is losing sales as its 2011 patent expiry approaches.
In the first quarter of this year sales fell by 7% to $3.1 billion (about £1.6 billion), but suffered particularly heavily in the important US market where they were down 18% on the previous quarter.
The company acknowledged the highly competitive nature of the US statin market, where there is competition from both branded and generic drugs in an increasingly cost-sensitive environment.
But chief executive and chairman Jeff Kindler added: "Lipitor remains a powerful global brand supported by extensive outcomes data and it continues to grow on an operational basis in many international markets." Pfizer also suffered at the hands of generic challengers across its portfolio, with profits falling 18% to $2.8 billion and revenues dropped 5%.
