FDA approves anti-epilepsy drug from Elan

Elan Corporation shares rose $1.94 to $44

Elan Corporation shares rose $1.94 to $44.31 late in the session on the New York Stock Exchange yesterday after it was announced that the US Food and Drug Administration (FDA) has approved a new anti-epilepsy drug.

The FDA has approved the marketing of Zonegran (zonisamide) capsules, an antiepilepsy drug indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Mr Donal Geaney, chairman and chief executive of Dublin-based Elan, said he believed the drug would be a welcome addition to the "roster of treatment" for epilepsy, since about one-third of the two million people with epilepsy in the US suffer from partial seizures not controlled with a single drug regime.

Zonegran was developed in Japan and in the US by Dainippon Pharmaceuticals of Osaka, Japan. It has been marketed in Japan under the name Excegran since 1989 - representing approximately one million patient years of exposure. Elan has licensed the sales and marketing rights for Zonegran from Dainippon for North America and Europe.

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Elan is the largest stock listed on the Dublin stock exchange. Its share price surged earlier this year when it announced that its application for its Ziconotide pain-killing drug had been accepted as filed by the FDA.

The FDA agreed a fast-track six month review of the application for the drug, which is being developed to treat severe chronic pain in diabetes, cancer and AIDS patients. The faster review period means that, if approved, the company could have the drug on the US market around the beginning of the fourth, quarter.

Elan's sales exceeded $1 billion in 1999, two years ahead of target, and it plans to double sales by 2003. How swiftly it can proceed towards this target depends significantly on how quickly it gets FDA approval for applications it has made.

Colm Keena

Colm Keena

Colm Keena is an Irish Times journalist. He was previously legal-affairs correspondent and public-affairs correspondent