Makers of MS drug Tysabri say FDA delaying verdict on drug's sale until June

Wednesday, March 22nd 2006, 8:35 am

By: News On 6

DUBLIN, Ireland (AP) _ The Irish and U.S. manufacturers of a suspended multiple sclerosis drug said Wednesday that American regulators have delayed until June their decision on whether to permit Tysabri to return to the market.

In a joint statement, Elan Corp. PLC of Ireland and Biogen Idec Inc. of Cambridge, Mass., said the Food and Drug Administration had extended the time it would take to reach a verdict from next week until late June.

``The companies have been informed by the FDA that the agency requires additional time to review information regarding the Tysabri risk management plan. Under this revised timeline, the companies anticipate action from FDA on or before June 28, 2006,'' the companies said.

The unexpected delay rattled investors in Elan, which is pinning its hopes for future profitability on Tysabri. In the first few hours of trading on the Irish Stock Exchange in Dublin, Elan shares fell 96 euro cents ($1.16), or 7.9 percent, to 11.22 euros ($13.56) _ about half their value before Tysabri's suspension from sale a year ago.

Jack Gorman, an analyst at Davy Stockbrokers in Dublin, described the FDA delay as ``a marginal negative.'' But he said his expectation that Tysabri would return to the market in mid-2006 ``remains fully intact.''

The FDA in November 2004 approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system. But Elan and Biogen withdrew the drug three months later when three people taking Tysabri in clinical trials contracted a rare, often fatal brain disease called PML; two died. Both companies subsequently said they found no additional PML cases among other Tysabri users.

On March 9, an advisory panel to the FDA voted unanimously to recommend that the agency should permit Tysabri to be sold again in the U.S., subject to new restrictions. The panel cited the drug's strong ability to help MS sufferers block the recurrence of key effects, such as sudden partial paralysis.