Elan passes milestone for new painkiller

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The Independent Online

The Irish drug company Elan announced yesterday that its treatment for severe chronic pain had passed a key trial and would be on the market no later than the first quarter of next year.

The Irish drug company Elan announced yesterday that its treatment for severe chronic pain had passed a key trial and would be on the market no later than the first quarter of next year.

The company, led by Kelly Martin, came close to insovlency last year and has been selling assets to bring its debts under control, It said its Prialt drug for patients with sever chronic pain had successfully completed Phase III trials.

The trial centred on patients who had not achieved pain relief with other therapies like, for example, intrathecally delivered (into the fluid in the spinal cord) morphine. At week three, the study - a double-blind, placebo-controlled study, showed that patients taking Prialt saw "statistically significant improvement".

Prialt is used in the treatment of severe chronic pain by patients suffering from illnesses such as cancer and Aids where other painkillers no longer work. It is administered intrathecally with an internal or external pump.

Elan said its analysis showed the treatment to be "safe, efficacious and well tolerated". It plans to file an amendment to its New Drug Application with the US Food and Drug Administration in the second quarter of this year.

It expects to bring the treatment - a drug it estimates could make revenues of $1.3bn to $1.5bn over its life -- to market no later than the first quarter of next year.

Analysts at NCB Stockbrokers are forecasting $20m of sales of Prialt in 2005 and $50m the year after that and predict the drug's peak annual sales potential is around $150m.

Lars Ekman, Elan's president of research and development, said: "We are very encouraged by these definitive findings with Prialt and believe that this is significant news for patients suffering with severe chronic pain, many of whom are not now adequately treated." The FDA had previously issued an approvable letter for Prialt, asking for more information. This latest study, the company said, fulfilled that requirement.

The trial studied 220 patients with severe chronic pain to show the efficacy and safety of lower doses of Prialt. Elan said there were few serious side effects.

Elan cited data which shows there are around 2 million patients in the United States with chronic pain who fail to respond to existing treatments. Of those, around 300,00 might be considered suitable for intrathecal treatment like Prialt.

It is a fillip for the company that has been battling to get its debt under control. Last month, Elan sold its European sales and marketing business to the private equity group Apax Partners for $120m.

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