Pharmaceutical R&D Pipeline News

Therapy Analysis - Drug Reprofiling

New indications for old drugs: a fruitful basis for drug discovery

The process of bringing novel pharmaceuticals to the market is becoming an increasingly costly business. Even for the giants of Big Pharma, delivering novel and profitable drugs to offset the ever-spiralling cost of pharmaceutical research is a delicate balancing act, one with huge financial risks involved.

For drugs to be successful, they must be both efficacious and acceptably safe. These obstacles make drug development increasingly difficult. Since 2003, around 200 drugs per year have been reported as discontinued (Graph 1), and ten times this many products are simply dropped from active pipelines (Graph 2). July saw Myriad Genetics discontinue its oral flurbiprofen analogue tarenflurbil, for the treatment of Alzheimer’s disease, after it failed to meet primary efficacy endpoints in Phase III trials. More recently, in October Merck & Co joined the lengthening list of companies to discontinue a CB1 antagonist, in this case taranabant for the treatment of obesity, after Phase III trial data suggested an unacceptable risk of psychiatric side-effects.

This pressure to deliver safe and effective drugs is further compounded post-launch by the limited patent life of newly-marketed drugs. The cost of blockbuster drugs coming off patent is estimated to total around US$29 billion in 2008, opening the way for generics to acquire a sizeable share of the market. This means that even following a successful launch, pharmaceutical companies face a race against time to try and gain a return on their huge investment in the development of that drug. The substantial risks and expenses involved in this process often leads pharmaceutical companies to seek new indications for already-known drugs; the process of drug reprofiling.

read full 'Drug Reprofiling' article>>