To: Dave Gore who wrote (8983 ) 6/28/2002 3:30:45 PM From: hotlinktuna Respond to of 16631 Dave...ELAB 17.60 +1.20 as ELN slides on this: Friday June 28, 11:30 am Eastern Time Reuters Company News FDA clears generic form of Elan's Zanaflex (Recasts, adds details throughout) NEW YORK, June 28 (Reuters) - Irish drugmaker Elan Corp (NYSE:ELN - News; Irish:ELN.I - News) said on Friday U.S. regulators approved a generic version of its key drug to treat muscle spasms, which will hurt Elan's sales in the second half of the year. ADVERTISEMENT The U.S. Food and Drug Administration cleared generic drugmaker Eon Labs Inc. (NasdaqNM:ELAB - News) to make a 4 mg dosage form of Elan's Zanaflex, known by chemical name tizanidine HCl, which treats muscle spasticity. Elan said it planned to quantify the expected financial impact of the development during its second-quarter earnings conference call in July. Eon Labs, which is based in New York, said it planned to begin shipments of the generic drug immediately. The news sent Elan shares, which have fallen 87 percent this year over concerns of its accounting methods and regulatory delays on key new medicines, down 15 percent, or 97 cents, to $5.63 on the New York Stock Exchange. Eon shares gained 5 percent, or 84 cents, to $17.24 on the Nasdaq market. Dublin-based Elan posted first-quarter Zanaflex sales in 2 mg and 4 mg dosage forms of $53.7 million, of which $40.3 million was accounted for by the Zanaflex 4 mg dosage. This represented about 9 percent of $429 million total revenue for the quarter. But Elan said it expects total net sales for Zanaflex in the third and fourth quarters to be lower than in the year's first two quarters. Second-quarter sales of the medicine are expected to be similar or slightly higher than sales recorded in the first quarter. Elan also said it had a "product enhancement strategy" for Zanaflex that it will continue to pursue, including new formulations and dosage forms. The Irish drugmaker is struggling to rebound from a series of setbacks this year. Early this year the U.S. Securities and Exchange Commission launched an investigation into Elan's accounting methods, which include special investment vehicles that have bolstered company earnings. Elan warned in February that its 2002 revenue growth would be slower than expected because of delays in launching new prescription drugs and because an earlier reorganization had not produced expected cost savings. The company suffered an especially painful setback this year when it was forced to halt mid-stage trials of its Alzheimer's vaccine after four patients fell sick. It has also suffered long delays in winning U.S. approval for migraine treatment Frova and Myobloc for muscle spasms. And U.S. regulators have required Elan to conduct an unexpected new 18-month safety trial on experimental pain treatment Prialt. Email this story - Most-emailed articles - Most-viewed articles -------------------------------------------------------------------------------- More Quotes and News: Elan Corp PLC (Irish:ELN.I - News; NYSE:ELN - News) Eon Labs Inc (NasdaqNM:ELAB - News) Related News Categories: biotech, health care, medical/pharmaceutical ELAB just a few cents from 52wk high...tuna