Elan makes new application in the US for ziconotide

Elan Corporation has submitted a new drug application in the US for ziconotide, a new treatment for chronic intractable pain in diabetes, cancer and AIDS patients.

If approved, the firm plans a roll-out of the drug in the second half of the new year, focusing first on the US market. Elan's president and chief operations officer Mr John Groom said the drug had potential market of about one million patients in the US.

Asked about Elan's potential revenue from the drug, Mr Groom said: "Most analysts are predicting revenues in the $300$500 million (€298.5497.5 million) category once peak sales are reached." He added that this would take "three to five years".

Ziconotide was discovered by Neurex, a US firm which Elan purchased for $700 million in 1998.

Elan described the drug as a neuronal calcium channel blocker, which will be administered through the spinal chord using an implanted pump. While this system was common in the US, it was not generally available in Europe, Mr Groom said.

The target market would include about 750,000 patients in the US with advanced diabetic and circulatory conditions and 250,000 cancer and AIDS patients, he said. The cost per patient would be $6,000-$8,000 per year.

The treatment, which blocks pain signals to the brain, does not deal with the patients' underlying condition, Mr Groom said. "These are very difficult patients who no longer respond to other forms of treatment."

Elan hopes to complete a filing for approval to sell the drug in Europe next year, with a roll-out in some markets in 2001. The firm also plans to apply to administer ziconotide epidurially to treat acute post-operative pain.

The firm was planning to introduce about five products in 2000, Mr Groom said. These included a treatment for epilepsy known as zonegran and a migraine treatment known as frovatriptan, both of which are at different stages of review by the Food and Drug Administration in the US.

The new drug application submission for ziconotide, which comprised more than 750 volumes and 300,000 pages of text, contains analyses of more than 1,000 patients treated with ziconotide. In two key studies, patients treated with ziconotide experienced a significant reduction in pain compared to use of a placebo.

Patients included in the pain studies had either failed systematic opioid or morphine-like therapy, or become intolerant of therapy due to side effects.